[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"allogeneic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:allogeneic-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100483795","apollo-personalized-rehabilitation-program-in-allogeneic-bone-marrow-transplantation-100483795",false,"NCT05579678","APOLLO: Personalized rehAbilitation PrOgram in aLLOgeneic Bone Marrow Transplantation","APOLLO","Inclusion Criteria:\n\n* eligible for allogeneic transplantation\n\nExclusion Criteria:\n\n* none","ALL","18 Years","70 Years",{"count":20,"type":21},45,"ESTIMATED","OBSERVATIONAL","People who undergo allogeneic bone marrow transplant for blood cancers receive the highest chemotherapy doses possible that humans can receive and still survive. As a result, they have devastating side effects during the procedure and for many years afterwards. Damage to organs and muscles cause long-lasting physical weakness and the psychological experience is severe enough to be termed 'post traumatic stress disorder' that also lasts for many years. These effects are worsened by the fact that most Canadians live several hours away from treatment and transplant centers, leaving them entirely on their own to manage these difficult long term effects. The APOLLO team will perform a qualitative study to learn the experiences of people undergoing allogeneic bone marrow transplant while they receive access to a supportive care computer 'app' and telephone support from nursing, exercise and nutrition experts. In this way, the APOLLO team will learn the most helpful type and timing of supportive care from those who know best.",[25],"Allogeneic Disease","RECRUITING","2026-05-06",{"date":29,"type":30},"2026-05-11","ACTUAL",{"date":32,"type":30},"2022-11-20",{"date":34,"type":21},"2026-08-31",{"name":36,"class":37},"University of Alberta","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":52,"conditions":53,"keywords":64,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100605053","phase-2-radioimmunotherapy-conditioning-with-131i--apamistamab-for-allogeneic-transplant-in-relapserefractory-aml-100605053","NCT07157514","Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse\u002FRefractory AML","An Adaptive, Operationally Seamless Phase II \u002F III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease","Inclusion Criteria:\n\n1. Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.\n2. 2R\u002FR AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission \\\u003C6 months, relapse refractory to salvage combination therapy or second or subsequent relapse\n3. Documented CD45 expression by leukemic cells via flow cytometry.\n4. ≥18 years of age and not suitable for myeloablative conditioning regimen.\n5. Circulating blast count \\\u003C10,000\u002Fmm³ (hydroxyurea allowed).\n6. Calculated creatinine clearance (Cockcroft-Gault) \\>50 mL\u002Fmin.\n7. Adequate hepatic function: AST\u002FALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).\n8. Karnofsky performance score ≥70.\n9. Expected survival \\>60 days.\n10. Central venous catheter line in place before study treatment.\n11. 8\u002F8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).\n12. Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.\n13. Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.\n14. Able to understand procedures, provide informed consent, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Positive human anti-mouse antibody (HAMA) at screening.\n2. \\>20% leukemic blasts in marrow.\n3. Prior radiation to maximally tolerated levels of any critical organ.\n4. Active CNS leukemia (blasts in CSF or CNS chloromas).\n5. Prior allogeneic or autologous HSCT.\n6. Candidates suitable for myeloablative conditioning.\n7. Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy\n8. QTcF \\>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).\n9. Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).\n10. Active, uncontrolled infection.\n11. Acute promyelocytic leukemia (t\\[15;17\\]).\n12. Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (\\>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression\n13. Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.\n14. Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).",{"count":47,"type":21},306,"INTERVENTIONAL",[50,51],"PHASE2","PHASE3","This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.",[54,55,56,57,58,59,60,61,62,25,63],"Acute Leukemia","Myeloid Leukemia","Acute Myelogenous Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Transplant-Related Disorder","Refractory AML",[57,65,66,67,68,69,63,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Leukemia","Acute Myeloid","Acute Bone Marrow Cell Transplant","Transplant","Bone Marrow HCT","Relapsed AML","I-131","Iomab","I131- Apamistamab","Iodine","Iodine-131","131-I AML","Iomab-B","Radioimmunotherapy","Allogeneic Transplant","Radiotherapy","CD45","Anti-CD45 antibody","Apamistamab","Fludarabine","Bone Marrow Transplant","Radiolabeled antibody therapy","131I -apamistamab","NOT_YET_RECRUITING","2025-09-04",{"date":91,"type":30},"2025-09-10",{"date":93,"type":21},"2026-01",{"date":95,"type":21},"2034-02",{"name":97,"class":98},"Actinium Pharmaceuticals","INDUSTRY",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":48,"phases":109,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100505005","phase-1-wharton-jelly-mesenchymal-stromal-cells-as-gvhd-prophylaxis-100505005","NCT05855707","Wharton Jelly Mesenchymal Stromal Cells as GVHD Prophylaxis","Wharton's Jelly Mesenchymal Stromal Cell (WG-MSC) Injections as GVHD Prophylaxis in Hematopoietic Allogeneic Stem Cell Transplantation With an Haplo-identical Donor : a Dose Escalation Study","HAPLO-GEL","Inclusion Criteria:\n\n* With AML\u002FALL\u002FSMD\u002FSMP or lymphoid neoplasm requiring allogeneic stem cell transplantation\n* In complete response (CR) for AML\u002FALL or CR,partial response (PR) or non pre-treated for SMD\u002FSMP and lymphoid neoplasm\n* Without a HLA matched related donor available and with identification of a haploidentical donor (brother, sister, parents, adult children or cousin)\n\nWith usual criteria for HSCT:\n\n* ECOG ≤ 2\n* No severe and uncontrolled infection\n* Cardiac function compatible with high dose of cyclophosphamide\n* Adequate organ function: ASAT and ALAT ≤ 2N, total bilirubin ≤ 1.5N, creatinine clearance ≥30ml\u002Fmin (except if those abnormalities are linked to the hematological disease)\n\n  * Requiring a RIC or non myeloablative conditioning:\n\n    (i) \\>50 years old; (ii) heavily pre-treated; (iii) Comoribidities according to Sorror et al. Blood 2005;106(8):2912-9, notamment HCT\u002FCI≥ 3 (JAMA. 2011 Nov 2;306(17):1874-83).\n  * With health insurance coverage (bénéficiaire ou ayant droit)\n  * Understand informed consent or optimal treatment and follow-up\n  * Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment and within 12 months for women of childbearing age and 6 months for men of childbearing age after the last dose of cyclophosphamide\n\nExclusion Criteria:\n\n* History of Cancer in the last 5 years\n* Uncontrolled infection: Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR HBV or HCV and hepatic cytolysis due to HBV\n* Uncontrolled coronary insufficiency, recent myocardial infarction \\\u003C6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \\\u003C50%\n* Pulmonary failure with DLCO\\\u003C50%\n* Addition of immunosuppressant treatment for GVHD prophylaxis (except immunosuppressant allowed per protocol)\n* Renal failure with creatinine clearance \\\u003C50ml \u002F min\n* Pregnancy (β-HCG positive) or breast-feeding\n* Any debilitating medical or psychiatric illness which would preclude the realization of the SCT or the understanding of the protocol\n* Under protection by law (tutorship or curatorship)\n* Unwilling or unable to comply with the protocol",{"count":108,"type":21},12,[110],"PHASE1","Despite progress in chemotherapy, targeted therapy and immunotherapy, allogeneic hematopoietic stem cell transplantation (allo-SCT) is still the only curative procedure for some hematological malignancies. The probability of finding a matched sibling donor (MSD) is estimated under the classical 30%, because of the age of patients and their relatives, and a matched unrelated donor (MUD) can take time to identify. Currently in France, 25% of the allo-SCT are performed with an haplo-identical related donor. The Baltimore group developed an approach using haploidentical related donors, RIC, T-replete bone marrow and post-transplant high dose cyclophosphamide (PTCy) in patients with advanced hematological malignancies. PTCy has shown to eradicate alloreactive donor and host T-cells, activated by respective antigens, thereby reducing the incidence of graft versus host disease (GvHD) but delaying hematopoietic recovery. Therefore, the main source of graft is peripheral blood stem cells (PBSC) mobilized by G-CSF in France. Unfortunately, with PBSC we observe a higher cumulative incidence of GvHD (around 50%) and a higher toxicity-related mortality (TRM), especially for recipients \\>50 years old. The co-transplantation of Mesenchymal Stem Cells (MSC) at the time of transplantation has previously shown a double interest in GvHD immunomodulation and hematopoiesis support. Pre-clinical studies (in mice) have shown that mesenchymal stromal cells (MSCs) from Wharton's Jelly reduce the incidence of GvHD when the infusions are weekly repeated. We propose a phase I clinical trial to find the maximum tolerated dose (MTD) of a weekly infusion of WJ-MSC administered as GvHD prophylaxis and as a support for a faster hematological reconstitution after haplo-identical allo-SCT.",[25,113,114],"GVHD,Acute","Graft Failure","2023-05-04",{"date":117,"type":30},"2023-05-11",{"date":119,"type":21},"2023-09",{"date":121,"type":21},"2026-09",{"name":123,"class":37},"Central Hospital, Nancy, France"]