Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed/ Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) at the end of 2 cycles for intravenous (IV) ascorbic acid (AA) added to standard salvage therapy compared to standard salvage therapy plus normal saline in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who have relapsed within the first 24 months of end of their therapy. \[Arms A versus (vs) B\] II. To determine the ORR at the end of 2 cycles of AA plus standard salvage chemotherapy in patients with other types of relapsed/refractory lymphomas not eligible for Arms A/B \[peripheral T-cell lymphoma (P…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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:…
Interventions
- Dietary SupplementAscorbic Acid
Given IV
- DrugCarboplatin
Given IV or PO
- DrugCisplatin
Given IV or PO
- DrugCytarabine
Given IV or PO
- DrugDexamethasone
Given IV or PO
- DrugEtoposide
Given IV or PO
- DrugGemcitabine Hydrochloride
Given IV or PO
Locations (4)
- Mayo Clinic Health Systems-MankatoMankato, Minnesota
- Mayo Clinic in RochesterRochester, Minnesota
- Mayo Clinic Health System-Eau Claire ClinicEau Claire, Wisconsin
- Mayo Clinic Health System-Franciscan HealthcareLa Crosse, Wisconsin