High-dose IV ascorbic acid therapy for patients with CCUS with TET2 mutations.
Zhuoer Xie, Jenna Fernandez, Terra Lasho...
https://pubmed.ncbi.nlm.nih.gov/39352751Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID03418038
Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed or Refractory Lymphoma, Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia
Led by Mayo Clinic · Updated on 2026-04-16
80
Participants Needed
4
Research Sites
140 weeks
Total Duration
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Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of high dose intravenous ascorbic acid combined with chemotherapy in patients with relapsed or refractory lymphomas, clonal cytopenia of undetermined significance (CCUS), and chronic myelomonocytic leukemia (CMML). This phase II trial aims to determine how ascorbic acid added to standard chemotherapy affects response rates, safety, and survival outcomes compared to chemotherapy alone. The study also explores biological markers related to oxidative stress and DNA methylation to better understand treatment effects. Participants are assigned to different treatment arms based on their disease type. Some receive intravenous ascorbic acid plus combination chemotherapy every 21 days for up to 4 cycles, while others receive placebo with chemotherapy or ascorbic acid alone with varying schedules. Specific regimens include drugs such as rituximab, ifosfamide, carboplatin, etoposide, decitabine, and others, administered intravenously or orally. Some patients undergo stem cell transplantation based on their response. The study includes procedures like blood sample collection, biopsies, echocardiography, PET/CT or MRI scans, and central venous line placement. During the study, participants undergo regular assessments to monitor treatment response and side effects. These include imaging scans, bone marrow biopsies, and blood tests to evaluate overall response rates and hematologic improvements. Follow-up visits occur every 3 months initially, then every 6 months after disease progression for up to 2 years. Researchers also collect patient-reported outcomes and monitor safety events throughout the study period to better understand the impact of the treatments being tested.
CONDITIONS
Brief 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
You may qualify if you...
- Age 18 years or older
- Biopsy-proven relapsed or refractory lymphoma with measurable or assessable disease
- Eligible for specific chemotherapy regimens depending on lymphoma type
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Adequate blood counts and organ function within specified limits
- Negative pregnancy test if applicable
- Willingness to have a central venous line placed
- Willingness to provide mandatory blood and tissue specimens for research
- Willingness to return for follow-up visits
- Diagnosis of CCUS with specific mutations for ARM D
- New or established diagnosis of CMML with specific mutations for ARM E
- Ability to complete questionnaires as required
You will not qualify if you...
- Pregnant or nursing persons
- Persons unwilling to use adequate contraception if of childbearing potential
- Recent therapy within 2 weeks before registration (with some exceptions)
- Severe concurrent illnesses or uncontrolled infections
- Active central nervous system lymphoma or involvement requiring specific therapy
- Other active malignancies except certain treated cancers
- History of recent myocardial infarction or significant heart failure
- Known glucose-6-phosphate dehydrogenase deficiency
- Uncontrolled or symptomatic kidney stones
- Known paroxysmal nocturnal hemoglobinuria
- For ARM D and E, additional exclusions related to co-morbidities, infections, or heart conditions
- Use of systemic immunosuppressive steroids above specified doses for ARM E
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 cycles over several months depending on arm
Participants receive intravenous ascorbic acid combined with chemotherapy or placebo according to their assigned arm. Treatment cycles repeat every 21 or 28 days depending on the arm, with up to 4 cycles for arms A, B, and C, up to 3 cycles for arm D, and up to 12 cycles for arm E. Participants undergo blood sample collection, biopsies, and imaging throughout treatment. Arm D and E participants also have central venous line placement before starting treatment.
Multiple visits every 21 or 28 days for up to 12 cycles depending on arm
Follow-up
Duration - Up to 2 years
After treatment completion, participants are followed up every 3 months, then every 6 months after any disease progression, for up to 2 years to monitor outcomes and safety.
Visits every 3 months initially, then every 6 months after progression
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
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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