[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-lymphoma":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,76,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100490236","collecting-blood-and-tissue-sample-donations-for-research-for-hivaids-related-cancers-100490236",false,"NCT05663502","Collecting Blood and Tissue Sample Donations for Research for HIV\u002FAIDS-Related Cancers","Biospecimen Collection and Donation to the AIDS and Cancer Specimen Resource (ACSR): A Companion Protocol to AMC Trials","Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Participant must be HIV- positive and have a diagnosed malignancy. If participants are HIV-negative, they must have a newly diagnosed or recurrent malignancy that has an established scientific connection (e.g., shared etiology) to an AIDS- associated malignancy such as:\n\n  * classic Kaposi sarcoma\n  * transplant-associated Kaposi sarcoma,\n  * anal cancer,\n  * multicentric Castleman's disease,\n  * Epstein Barr Virus (EBV) -positive lymphoma\n  * plasmablastic lymphoma\n  * Hodgkin's lymphoma.\n\n    * For participants that are HIV-positive, HIV infection must be documented by means of any one of the following: :\n\n      * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n      * Documentation of receipt of antiretroviral therapy (ART) by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Receipt of at least two agents is required; each component agent of a multi-class combination ART regimen will be counted toward the 2-agent requirement, excepting receipt of a pre-exposure prophylaxis (PrEP) regimen alone \\[e.g., Truvada\\], which is exclusionary);\n      * HIV ribonucleic acid (RNA) detection by a licensed HIV RNA assay demonstrating \\> 1000 RNA copies\u002FmL;\n      * Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n* Participants with HIV infection, regardless of participation in an AMC clinical trial, must have a diagnosis of cancer, cancer or a condition that places them at a higher risk of cancer.\n* The investigator determines that the participant (or his\u002Fher legally authorized representative \\[LAR\\]) has the ability to provide informed consent and the participant or LAR provides written informed consent.","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","This study collects blood and tissue samples for research of human immunodeficiency virus (HIV)\u002Facquired immunodeficiency syndrome (AIDS)-related cancers. Collecting blood and tissue samples and studying biomarkers in the laboratory may help doctors to learn how are biologic or genetic factors related to HIV and cancers that occur commonly in people living with HIV.",[24,25,26,27,28,29,30,31,32,33,34,35],"Anal Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","HIV Infection","Kaposi Sarcoma","Lymphoma","Malignant Solid Neoplasm","Multicentric Castleman Disease","Plasmablastic Lymphoma","Recurrent Kaposi Sarcoma","Recurrent Lymphoma","Recurrent Plasmablastic Lymphoma","Transplant-Related Kaposi Sarcoma","RECRUITING","2026-05-28",{"date":39,"type":40},"2026-06-01","ACTUAL",{"date":42,"type":40},"2023-05-10",{"date":44,"type":20},"2035-08-31",{"name":46,"class":47},"AIDS Malignancy Consortium","NETWORK",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100193148","effects-of-dexrazoxane-hydrochloride-on-biomarkers-associated-with-cardiomyopathy-and-heart-failure-after-cancer-treatment-100193148","NCT01790152","Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment","Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy","Inclusion Criteria:\n\nStudy Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV\n\n* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS\n* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)\n* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia\u002Flymphoblastic lymphoma \\[P9404, high-risk DFCI 95-01\\] or Hodgkin lymphoma \\[P9425\u002FP9426\\])\n* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation\n* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \\[also includes fields directed towards the neck, upper abdomen, or spine\\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible\n* STRATUM I: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \\[COG?s\\] Statistics and Data Center \\[SDC\\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse\u002Fsubsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)\n* STRATUM II: Alive, but have experienced relapse of their original cancer and\u002For have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis\n* STRATUM II: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM III: OSTEOSARCOMA SURVIVORS\n* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and\u002For parents\u002Flegal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors\n* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:\n\n  * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible\n  * \\\u003C 31 years of age at time of initial osteosarcoma diagnosis\n  * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002\n  * No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \\>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \\>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis\n  * Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg\u002Fm\\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria\n  * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies\n  * No exposure to DRZ at any point in time\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3\n* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and\u002For radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year\n* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \\[DICOM\\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable\n* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)\n* Based on echocardiography, must have either left ventricular fractional shortening =\\\u003C 28.0% or ejection fraction =\\\u003C 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection\n* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \\[ACE\\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months\n* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":57,"type":20},420,"This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.",[60,61,62,63,64,33,65],"Hodgkin Lymphoma in Remission","Leukemia in Remission","Lymphoblastic Lymphoma","Osteosarcoma","Recurrent Leukemia","Recurrent Malignant Neoplasm","2026-05-14",{"date":68,"type":40},"2026-05-18",{"date":70,"type":40},"2014-03-05",{"date":72,"type":20},"2026-12-31",{"name":74,"class":47},"Children's Oncology Group",79,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":109},"100429351","phase-1-cbl0137-for-the-treatment-of-relapsed-or-refractory-solid-tumors-including-cns-tumors-and-lymphoma-100429351","NCT04870944","CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma","A Phase 1\u002F2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma","Inclusion Criteria:\n\n* Parts A and B: Patients must be \\>= 12 months and =\\\u003C 21 years of age at the time of study enrollment\n* Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n\n  * Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including untreated or progressive) are eligible\n  * Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy\n* Part A: Patients must have either measurable or evaluable disease\n* Part B: Patients must have measurable disease\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age. Patients must have a Karnofsky or Lansky score \\>= 50%\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive\n\n    * Solid tumor patients: \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids: If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid. Patients with CNS tumors receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy \\[XRT\\]\u002Fexternal beam irradiation including protons: \\>= 14 days after local XRT; \\>= 150 days after TBI, craniospinal XRT or if radiation to \\>= 50% of the pelvis; \\>= 42 days if other substantial bone marrow (BM) radiation\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, I-131 metaiodobenzylguanidine \\[131I MIBG\\]): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior exposure to CBL0137\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* For patients with solid tumors without known bone marrow involvement:\n\n  * Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (performed within 7 days prior to enrollment unless otherwise indicated)\n  * Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. At least 5 of every cohort of 6 patients must be evaluable for hematologic toxicity for the dose-escalation part of the study. If dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 or a creatinine based on age\u002Fsex as follows (performed within 7 days prior to enrollment unless otherwise indicated):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n  * 1 to \\\u003C 2 years: 0.6 (male); 0.6 (female)\n  * 2 to \\\u003C 6 years: 0.8 (male); 0.8 (female)\n  * 6 to \\\u003C 10 years: 1 (male); 1 (female)\n  * 10 to \\\u003C 13 years: 1.2 (male); 1.2 (female)\n  * 13 to \\\u003C 16 years: 1.5 (male); 1.4 (female)\n  * \\>= 16 years: 1.7 (male); 1.4 (female)\n* Patients with solid tumors:\n\n  * Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with solid tumors:\n\n  * Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL (performed within 7 days prior to enrollment unless otherwise indicated)\n* Shortening fraction of \\>= 27% by echocardiogram (performed within 7 days prior to enrollment unless otherwise indicated) or\n* Ejection fraction of \\>= 50% by gated radionuclide study (performed within 7 days prior to enrollment unless otherwise indicated)\n* Corrected QT (QTC) \\\u003C 480 msec (performed within 7 days prior to enrollment unless otherwise indicated)\n* Patients with seizure disorder may be enrolled if seizures well controlled without the use of enzyme-inducing anti-convulsant agents. Well controlled is defined by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior therapy must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* Patients have consented to receive a central venous catheter prior to the administration of CBL0137. A central line is required for CBL0137 administration\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving drugs that are strong inducers or inhibitors of CYP3A4, CYP2B6 (e.g., carbamazepine) and CYP1A2 (e.g., ciprofloxacin, enoxacin, fluvoxamine, smoking) are not eligible. These agents are to be avoided for 7 days prior to the start of CBL0137 and for the duration of the protocol therapy. Sensitive substrates of CYP2D6 (e.g., atomoxetine, desipramine, dextromethorphan, eliglustat, nebivolol, nortriptyline, perphenazine, tolterodine, R-venlafaxine) should also be avoided for the duration protocol therapy\n* Patients who are receiving drugs associated with a known risk of Torsades de Pointes (TdP) are not eligible. Drugs associated with known risk of Torsades de Pointes (TdP) are to be avoided for 7 days prior to the start of CBL0137 and for duration of the protocol therapy\n* Patients with known peripheral vascular disease are excluded\n* Patients with a history of pro-thrombotic disorder are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","12 Months","21 Years",{"count":86,"type":20},63,"INTERVENTIONAL",[89,90],"PHASE1","PHASE2","This phase I\u002FII trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.",[93,94,95,96,33,97,98,99,100,101],"Diffuse Midline Glioma, H3 K27-Altered","Metastatic Malignant Neoplasm in the Central Nervous System","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Diffuse Midline Glioma, H3 K27-Altered","Recurrent Malignant Solid Neoplasm","Recurrent Primary Malignant Central Nervous System Neoplasm","Refractory Lymphoma","Refractory Malignant Solid Neoplasm","Refractory Primary Malignant Central Nervous System Neoplasm","2026-05-01",{"date":104,"type":40},"2026-05-05",{"date":106,"type":40},"2022-01-28",{"date":72,"type":20},{"name":74,"class":47},35,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":87,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":5},"100317852","phase-2-ascorbic-acid-and-chemotherapy-for-the-treatment-of-relapsed-or-refractory-lymphoma-ccus-and-chronic-myelomonocytic-leukemia-100317852","NCT03418038","Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia","Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed\u002F Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted \\> 6 months; refractory is no response or relapse within 6 months; previous biopsies \\\u003C 6 months prior to treatment on this protocol will be acceptable\n\n  * NOTE: Arms A\u002FB - relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\n  * NOTE: Arm C patients include relapsed or refractory lymphoma patients of any type for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed or refractory double-hit high grade lymphoma patients and relapsed or refractory Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding\n* Measurable or assessable disease: measurable disease is defined as measurable by computed tomography (CT) \\[dedicated CT or the CT portion of a positron emission tomography (PET)\u002FCT\\] or magnetic resonance imaging (MRI): to be considered measurable, there must be at least one lesion that has a single diameter of \\>= 1.5 cm\n\n  * NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler; patients with assessable disease by PET are also eligible as long as the assessable disease is biopsy proven lymphoma\n* Arms A\u002FB - eligible for treatment with ifosfamide, carboplatin, and etoposide (+\u002F- rituximab)\n* Arm C eligible for treatment with one of the following standard, every 3 week, platinum-based salvage regimens (with or without monoclonal antibody as appropriate for the disease):\n\n  * Ifosfamide\u002Fcarboplatin\u002Fetoposide (ICE) or rituximab\u002Fifosfamide\u002Fcarboplatin\u002Fetoposide (RICE);\n  * Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or RDHAP;\n  * Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);\n  * Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);\n  * Oxaliplatin, cytosine arabinoside, dexamethasone (OAD) or rituximab, oxaliplatin, cytosine arabinoside, dexamethasone (ROAD)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\>= 8.0 g\u002FdL (may transfuse to meet this requirement), obtained =\\\u003C 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Platelet count \\>= 75000\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN), obtained =\\\u003C 14 days prior to registration\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement), obtained =\\\u003C 14 days prior to registration\n* Creatinine =\\\u003C 1.6 mg\u002FdL; if over 1.6 then the calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula, obtained =\\\u003C 7 days prior to registration\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) test done =\\\u003C 14 days prior to registration\n\n  * If positive, the CD4 count must be \\> 400\n* Provide written informed consent\n* Willingness to have a central venous line \\[peripherally inserted central catheter (PICC) or PORT\\]\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM D: Patients who had a diagnosis of CCUS with one or more TET2 mutations or TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2) or epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2). CCUS diagnosis being defined based on the absence of definitive morphologic evidence of hematologic neoplasms from bone marrow biopsy evaluation combined with evidence of pathogenic myeloid somatic mutation with a variant allele frequency (VAF) of at least 2% using our institution's next generation sequencing (NGS) panel (OncoHeme, Mayo Clinic)\n* ARM D: ECOG performance status (PS) 0, 1 or 2\n* ARM D: Patients must meet at least 1 of these 3 laboratory criteria to be enrolled:\n\n  * Hemoglobin =\\\u003C 10g\u002FdL (obtained =\\\u003C 7 days prior to registration)\n  * Absolute neutrophil count (ANC) =\\\u003C 1000\u002Fmm\\^3 (obtained =\\\u003C 7 days prior to registration)\n  * Platelet count =\\\u003C 100,000\u002Fmm\\^ 3 (obtained =\\\u003C 7 days prior to registration)\n* ARM D: Total bilirubin =\\\u003C 2 x ULN (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Creatinine =\\\u003C 1.6 mg\u002FdL (obtained =\\\u003C7 days prior to registration). If \\> 1.6, then the Calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM D: Negative pregnancy test, for persons of childbearing potential only (obtained =\\\u003C 7 days prior to registration). NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* ARM D: Provide written informed consent\n* ARM D: Willingness to have a central venous line (PICC or PORT)\n* ARM D: Willingness to provide mandatory blood specimens for correlative research\n* ARM D: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM D: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM E PRE-REGISTRATION: Age ≥ 18 years\n* ARM E PRE-REGISTRATION: New or an established diagnosis of 2016 World Health Organization (WHO) defined chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation requiring treatment with DNA methyltransferase inhibitors\u002Fhypomethylating agents\n* ARM E PRE-REGISTRATION: No prior CMML directed therapy.\n\n  * Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. NOTE: Prior exposure to hydroxyurea is allowed. Continuation beyond the first cycle must be discussed with the principal investigator (PI)\n* ARM E PRE-REGISTRATION: Creatinine ≤ 1.6 mg\u002FdL. If \\> 1.6, then the Calculated creatinine clearance must be ≥ 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM E PRE-REGISTRATION: Willingness to provide mandatory research bone marrow sample for correlative research\n* ARM E PRE-REGISTRATION: ECOG performance status (PS) 0, 1, or 2\n* ARM E PRE-REGISTRATION: Provide written informed consent\n* ARM E REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* ARM E REGISTRATION: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM E REGISTRATION: Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* ARM E REGISTRATION: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Platelet count ≥ 20,000\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Total bilirubin ≤ 1.5 x ULN ( ≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Ability to complete questionnaire by themselves or with assistance\n* ARM E REGISTRATION: For a person of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study. Adequate contraception is defined as follows:\n\n  * Complete true abstinence\n  * Consistent and correct use of one of the following methods of birth control:\n\n    * Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient\n    * Implants of levonorgestrel\n    * Injectable progestogen\n    * Intrauterine device (IUD) with a documented failure rate of less than 1% per year\n    * Oral contraceptive pill (either combined or progesterone only)\n    * Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen\n* ARM E REGISTRATION: WOCBP must have a negative serum or urine pregnancy test ≤ 7 days prior to registration. NOTE: WOCBP include any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\> 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL. Even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* ARM E REGISTRATION: Persons who are able to father a child must use contraception during the study and for 3 months after the last treatment dose.\n\n  * Complete true abstinence\n  * Latex condom with a spermicidal agent\n  * Diaphragm with spermicide\n* ARM E REGISTRATION: Willingness to have a central venous line (PICC or PORT)\n* ARM E REGISTRATION: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any therapy =\\\u003C 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretion. Exception: Palliative radiation is allowed\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the lymphoma\n* Other active malignancy than lymphoma\n\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer that could interfere with this protocol therapy; patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria; patients with non-melanotic skin cancer may enroll\n* History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* Patients with active central nervous system (CNS) lymphoma or active cerebrospinal fluid (CSF) involvement with malignant cells requiring CNS-specific therapy with IV or intrathecal (IT) methotrexate (MTX); Note: Patients with any prior CNS lymphoma (parenchymal or leptomeningeal) MUST be in complete remission (CR) in those compartments without any maintenance therapy required\n* Patients with uncontrolled or symptomatic kidney stones\n* Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Bona-fide hematological neoplasm\n* ARM D: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* ARM D: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM D: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM D: History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM D: Patients with uncontrolled or symptomatic kidney stones\n* ARM D: Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E PRE-REGISTRATION: Myelodysplastic syndrome (MDS)\u002Fmyeloproliferative neoplasm (MPN) overlap syndromes other than CMML\n* ARM E PRE-REGISTRATION: Active central nervous system disease\n* ARM E PRE-REGISTRATION: Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* ARM E PRE-REGISTRATION: Concurrent active malignancy, except adequately treated nonmelanoma skin cancer. History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for \\> 2 years\n* ARM E PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM E PRE-REGISTRATION: Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of ≥ 20 mg\u002Fday prednisone (or equivalent). Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids\n* ARM E PRE-REGISTRATION: Patients with uncontrolled or symptomatic kidney stones\n* ARM E REGISTRATION: New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* ARM E REGISTRATION: History of myocardial infarction ≤ 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM E REGISTRATION: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac arrhythmia, unstable angina pectoris, clinically significant nonhealing or healing wounds, pulmonary congestion or pulmonary edema, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, clinical dehydration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM E REGISTRATION: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception",{"count":118,"type":20},80,[90],"This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.\n\nArms A, B, C, and D are closed to enrollment.",[122,123,124,125,33,126,99,127],"Clonal Cytopenia of Undetermined Significance","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Hodgkin Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Chronic Myelomonocytic Leukemia","2026-04-13",{"date":130,"type":40},"2026-04-16",{"date":132,"type":40},"2018-03-23",{"date":134,"type":20},"2033-11-02",{"name":136,"class":137},"Mayo Clinic","OTHER"]