OncoMatch/Clinical Trials/NCT03418038
Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
Official title: 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
Is NCT03418038 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments for clonal cytopenia of undetermined significance.
Treatment: Carboplatin · Cisplatin · Cytarabine · Dexamethasone · Etoposide · Gemcitabine Hydrochloride · Ifosfamide · Oxaliplatin · Rituximab · Decitabine · Decitabine and Cedazuridine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Primary Central Nervous System Lymphoma
Myelodysplastic Syndrome
Biomarker criteria
Required: MYC rearrangement
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Required: BCL2 rearrangement
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Required: BCL6 rearrangement
High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Required: TET2 mutation
CCUS with one or more TET2 mutations
Required: SRSF2 mutation
TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)
Required: U2AF1 mutation
TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)
Required: SF3B1 mutation
TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)
Required: ZRSR2 mutation
TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)
Required: DNMT3A mutation
epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2)
Required: EZH2 mutation
epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2)
Required: IDH1 mutation
epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2)
Required: IDH2 mutation
epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2)
Required: TET2 mutation
chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation
Required: IDH1 mutation
chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation
Required: IDH2 mutation
chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CMML directed therapy
Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. Prior exposure to hydroxyurea is allowed.
No prior CMML directed therapy
Lab requirements
Blood counts
Hemoglobin ≥ 8.0 g/dL (may transfuse to meet this requirement); ANC ≥ 1500/mm^3; Platelet count ≥ 75000/mm^3
Kidney function
Creatinine ≤ 1.6 mg/dL; if > 1.6 then calculated creatinine clearance must be ≥ 55 ml/min using Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2 x ULN (if > 2 x ULN direct bilirubin is required and should be ≤ 1.5 x ULN); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Hemoglobin ≥ 8.0 g/dL (may transfuse to meet this requirement), obtained ≤ 14 days prior to registration; ANC ≥ 1500/mm^3, obtained ≤ 14 days prior to registration; Platelet count ≥ 75000/mm^3, obtained ≤ 14 days prior to registration; Total bilirubin ≤ 2 x ULN (if > 2 x ULN direct bilirubin is required and should be ≤ 1.5 x ULN), obtained ≤ 14 days prior to registration; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement), obtained ≤ 14 days prior to registration; Creatinine ≤ 1.6 mg/dL; if over 1.6 then the calculated creatinine clearance must be ≥ 55 ml/min using the Cockcroft-Gault formula, obtained ≤ 7 days prior to registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Health Systems-Mankato · Mankato, Minnesota
- Mayo Clinic in Rochester · Rochester, Minnesota
- Mayo Clinic Health System-Eau Claire Clinic · Eau Claire, Wisconsin
- Mayo Clinic Health System-Franciscan Healthcare · La Crosse, Wisconsin
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03418038 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CMML directed therapy disqualifies patients from enrollment.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require BCL6?
Yes, BCL6 rearrangement is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify