Health Trials

Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia

ConditionsClonal Cytopenia of Undetermined SignificanceHigh Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent Diffuse Large B-Cell LymphomaRecurrent Hodgkin LymphomaRecurrent LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory LymphomaChronic Myelomonocytic Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Arms A, B, C, and D are closed to enrollment.

Eligibility criteria

Qualifiers

Age >= 18 years

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 < 6 months prior to treatment on this protocol will be acceptable

NOTE: Arms A/B - 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

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

Disqualifiers

Pregnant persons

Nursing persons

Persons of childbearing potential who are unwilling to employ adequate contraception

Any therapy =< 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

Trial design

Treatments tested in this trial

  • Ascorbic Acid
  • Carboplatin
  • Cisplatin
  • Cytarabine
  • Dexamethasone
  • Etoposide
  • Gemcitabine Hydrochloride
  • Ifosfamide
  • Laboratory Biomarker Analysis
  • Oxaliplatin
  • Placebo Administration
  • Questionnaire Administration
  • Rituximab
  • Decitabine
  • Biospecimen Collection
  • Core Biopsy
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Echocardiography
  • Positron Emission Tomography
  • Magnetic Resonance Imaging
  • Central Venous Cannula Insertion
  • Portacath Placement
  • Computed Tomography

Treatment groups

80 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov