Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03418038

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

Led by Mayo Clinic · Updated on 2026-04-16

80

Participants Needed

4

Research Sites

814 weeks

Total Duration

On this page

Sponsors

M

Mayo Clinic

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Biopsy-confirmed relapsed or refractory lymphomas with relapse after response lasting more than 6 months or refractory disease with no response or relapse within 6 months
  • For Arms A/B: Relapsed or refractory diffuse large B-cell lymphoma within 24 months of anthracycline-based therapy, no prior salvage therapy
  • For Arm C: Relapsed or refractory lymphoma eligible for platinum-based regimens; no limit on prior therapies; must not have had the same platinum regimen without response
  • Measurable or assessable disease by CT, PET/CT, or MRI with at least one lesion 1.5 cm or larger
  • Eligible for specific chemotherapy regimens per arm
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Adequate blood counts and organ function within specified limits
  • Negative pregnancy test for persons of childbearing potential
  • Negative HIV test or controlled HIV with CD4 count over 400
  • Willingness to provide informed consent, have central venous line placement, provide mandatory blood and tissue samples, and attend follow-up visits
  • ARM D: Diagnosis of CCUS with specified mutations; laboratory values meeting defined criteria; ECOG 0-2
  • ARM E: Diagnosis of CMML with specific mutations; no prior CMML therapy except limited exceptions; ECOG 0-2; adequate organ function; ability to complete questionnaires; contraceptive use if applicable
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons, or persons of childbearing potential unwilling to use adequate contraception
  • Therapy within 2 weeks prior to registration except specified exceptions
  • Severe co-morbid illnesses or uncontrolled intercurrent illnesses that may interfere with safety or study compliance
  • Receiving other investigational agents for lymphoma
  • Active malignancies other than lymphoma except certain treated cancers
  • Recent myocardial infarction, symptomatic heart failure, or significant heart dysfunction
  • Known glucose-6-phosphate dehydrogenase deficiency
  • Active central nervous system lymphoma or malignant cerebrospinal fluid involvement requiring CNS therapy
  • Uncontrolled or symptomatic kidney stones
  • Known paroxysmal nocturnal hemoglobinuria
  • ARM D: Presence of bona fide hematological neoplasm
  • ARM E: Myelodysplastic syndrome/myeloproliferative neoplasm overlap syndromes other than CMML, active CNS disease, active malignancy except certain treated cancers, severe co-morbid illnesses, uncontrolled illnesses, or contraindications to study drugs
  • Persons unwilling to comply with contraception requirements if applicable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States, 56001

Not Yet Recruiting

2

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

3

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States, 54701

Not Yet Recruiting

4

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States, 54601

Active, Not Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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