Study on Ascorbic Acid and Chemotherapy for Treating Relapsed or Hard-to-Treat Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03418038

Provider View

This clinical trial is exploring whether adding ascorbic acid (vitamin C) to chemotherapy can help treat patients with lymphoma that has returned or is not responding to treatment, as well as those with CCUS and chronic myelomonocytic leukemia. The study aims to see if ascorbic acid can make cancer cells more sensitive to chemotherapy, potentially killing more cancer cells.

Patient Parameters

Program Overview

This study is testing if combining ascorbic acid (vitamin C) with chemotherapy can help treat patients with certain types of cancer that have come back or are not responding to treatment. The cancers being studied include relapsed or refractory lymphoma, clonal cytopenia of undetermined significance (CCUS), and chronic myelomonocytic leukemia (CMML). Researchers believe that ascorbic acid might make cancer cells more sensitive to chemotherapy, which could help kill more cancer cells.

Description

The study is divided into different groups based on the type of cancer and treatment plan:

  • Arm A and B: Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will receive either ascorbic acid or a placebo along with standard chemotherapy. The goal is to see if ascorbic acid improves the response to treatment.

  • Arm C: Patients with other types of relapsed or refractory lymphomas will receive ascorbic acid with standard chemotherapy regimens. The aim is to evaluate the response rate and safety of this combination.

  • Arm D: Patients with CCUS will receive high-dose ascorbic acid to assess its effect on blood cell counts and overall health.

  • Arm E: Patients with chronic myelomonocytic leukemia (CMML) will receive ascorbic acid and decitabine to evaluate the response and safety of this treatment.

Throughout the study, patients will undergo various tests and procedures, including blood tests, imaging scans, and biopsies, to monitor their response to treatment and any side effects. After completing the study treatment, patients will have follow-up visits every few months to check their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of relapsed or refractory lymphoma, CCUS, or CMML.
  • Have measurable or assessable disease, meaning the cancer can be tracked using scans or other tests.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Women of childbearing potential must agree to use effective contraception during the study.
  • Be willing to provide blood and tissue samples for research purposes.
  • Be willing to return to the study site for follow-up visits.
  • For Arm D: Have a diagnosis of CCUS with specific genetic mutations.
  • For Arm E: Have a diagnosis of CMML with specific genetic mutations and no prior CMML-directed therapy.

Exclusion Criteria

  • Pregnant or nursing women.
  • People who are unwilling to use effective contraception if they are of childbearing potential.
  • Have received any other cancer treatment within two weeks before starting the study, with some exceptions.
  • Have other serious medical conditions that could interfere with the study.
  • Have active infections or other illnesses that are not well-controlled.
  • Have a history of heart attack within the last six months or severe heart problems.
  • Have a known deficiency in G6PD, an enzyme important for red blood cell function.
  • Have active cancer in the central nervous system or other active malignancies, with some exceptions for certain skin cancers.
  • For Arm D: Have a confirmed diagnosis of a blood cancer other than CCUS.
  • For Arm E: Have other overlapping blood disorders or active central nervous system disease.

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