Actively Recruiting
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
Eligibility Criteria
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
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
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
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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