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NCT03418038 · ClinicalTrials.gov registry record · Phase 2
Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
A Phase 2 study of Chronic Myelomonocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 4
- Study locations
NCT03418038: Recruiting Phase 2 study of Chronic Myelomonocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, sponsored by Mayo Clinic.
NCT03418038 is a Phase 2 study of Chronic Myelomonocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 80 participants, roughly in line with the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target. The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03418038, a Phase 2 study of Chronic Myelomonocytic Leukemia and Recurrent Diffuse Large B-Cell Lymphoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Defined as an objective status of complete response (CR) or partial response (PR) evaluated by Response Evaluation Criteria in Lymphoma (RECIL) criteria after 2 courses of treatment in all arms. Will be compared between the two arms. The proportion of successes will be estimated in each arm by the number of successes divided by the total number of evaluable patients. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. For the di
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Dexamethasone
- DRUG Cytarabine
- DIETARY_SUPPLEMENT Ascorbic Acid
Study Locations (4)
Minnesota
- Mayo Clinic Health Systems-Mankato - Mankato
- Mayo Clinic in Rochester - Rochester
Wisconsin
- Mayo Clinic Health System-Eau Claire Clinic - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-03-23 |
| Est. Completion | 2033-11-02 |
| Phase | Phase 2 |
What NCT03418038 shows while recruiting
NCT03418038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target.
The record links to 8 conditions, with Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03418038 reports a single indexed study location in Minnesota, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03418038 about?
NCT03418038 is a clinical study titled "Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia". 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 ...
What is the current status of trial NCT03418038?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2018-03-23. Estimated completion is 2033-11-02.
What conditions does trial NCT03418038 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Clonal Cytopenia of Undetermined Significance.
What interventions are being tested in trial NCT03418038?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Ascorbic Acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03418038?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03418038 being conducted?
This trial has 4 study locations across Minnesota, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03418038's enrollment target sits among peer trials
80 20th of 73 higher than 54 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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