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OncoMatch/Clinical Trials/NCT03418038

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

Is NCT03418038 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for clonal cytopenia of undetermined significance.

Phase 2RecruitingMayo ClinicNCT03418038Data as of May 2026

Treatment: Carboplatin · Cisplatin · Cytarabine · Dexamethasone · Etoposide · Gemcitabine Hydrochloride · Ifosfamide · Oxaliplatin · Rituximab · DecitabineThis 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.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Diffuse Large B-Cell Lymphoma

Hodgkin Lymphoma

Acute Myeloid Leukemia

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: TET2 mutation with concurrent splicing gene mutation

TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)

Required: SRSF2 mutation

splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)

Required: U2AF1 mutation

splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)

Required: SF3B1 mutation

splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2)

Required: ZRSR2 mutation

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: salvage therapy

no prior salvage therapy

Cannot have received: same platinum-based regimen

Exception: must not have received the same regimen in the past without responding

must not have received the same regimen in the past without responding

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. Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. Prior exposure to hydroxyurea is allowed.

Cannot have received: any therapy

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

Any therapy ≤ 2 weeks prior to registration

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 over 1.6 then the calculated creatinine clearance must be ≥ 55 ml/min using the 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 →

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