Phase 2 Study of High-Dose Intravenous Ascorbic Acid with Chemotherapy for Treating Relapsed or Refractory Lymphoma, Clonal Cytopenia, and Chronic Myelomonocytic Leukemia

What this Trial Is About

Researchers are evaluating the effects of high dose intravenous ascorbic acid combined with chemotherapy in patients with relapsed or refractory lymphomas, clonal cytopenia of undetermined significance CCUS, and chronic myelomonocytic leukemia CMML. This phase II trial aims to determine how ascorbic acid added to standard chemotherapy affects response rates, safety, and survival outcomes compared to chemotherapy alone. The study also explores biological markers related to oxidative stress and DNA methylation to better understand treatment effects. Participants are assigned to different treatment arms based on their disease type. Some receive intravenous ascorbic acid plus combination chemotherapy every 21 days for up to 4 cycles, while others receive placebo with chemotherapy or ascorbic acid alone with varying schedules. Specific regimens include drugs such as rituximab, ifosfamide, carboplatin, etoposide, decitabine, and others, administered intravenously or orally. Some patients undergo stem cell transplantation based on their response. The study includes procedures like blood sample collection, biopsies, echocardiography, PETCT or MRI scans, and central venous line placement. During the study, participants undergo regular assessments to monitor treatment response and side effects. These include imaging scans, bone marrow biopsies, and blood tests to evaluate overall response rates and hematologic improvements. Follow-up visits occur every 3 months initially, then every 6 months after disease progression for up to 2 years. Researchers also collect patient-reported outcomes and monitor safety events throughout the study period to better understand the impact of the treatments being tested.

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