Trial · NCT03418038
Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
NCT03418038, Phase 2, Recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia. Trials, record NCT03418038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03418038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia
- NCT number
- NCT03418038
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Mayo Clinic
- Conditions
Clonal Cytopenia of Undetermined Significance, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Hodgkin Lymphoma, Recurrent Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Lymphoma, Chronic Myelomonocytic Leukemia
- Interventions
Ascorbic Acid, Carboplatin, Cisplatin, Cytarabine, Dexamethasone, Etoposide, Gemcitabine Hydrochloride, Ifosfamide, Laboratory Biomarker Analysis, Oxaliplatin, Placebo Administration, Questionnaire Administration, Rituximab, Decitabine, Biospecimen Collection, Core Biopsy, Bone Marrow Aspiration, Bone Marrow Biopsy, Echocardiography, Positron Emission Tomography, Magnetic Resonance Imaging, Central Venous Cannula Insertion, Portacath Placement, Computed Tomography, Decitabine and Cedazuridine
- First posted
- 2018-02-01
- Last updated
- 2026-09-28
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) (Arms A and B) | Up to 2 years | 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 diffuse large B-cell lymphoma (DLBCL) arms, comparison of overall response rates between the two treatment groups will be performed using a one-sided chi-square test at significance level 0.10. |
| Primary | ORR (Arm C) | Up to 2 years | Defined as an objective status of CR or PR evaluated by RECIL criteria after 2 cycles of treatment. The proportion of successes will be estimated 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. |
| Primary | Hematologic response (HI) rate (Arm D) | At 20 weeks | Defined as an objective status of HI-E (minor or major response), HI-P, or HI-N evaluated by Myelodysplastic Syndrome International Working Group (IWIG) 2018 criteria at 20 weeks. Exact binomial ninety-five percent confidence intervals for the true success proportion will be calculated in each arm. |
| Primary | Overall Response Rate (ORR) in Arm E | At completion of cycle 4 (each cycle is 21 days) | Defined as an objective status of complete remission, complete cytogenetic remission, partial remission, bone marrow response, or clinical benefit after 4 cycles of therapy as defined by the 2015 IWG myelodysplastic syndrome/ myeloproliferative neoplasm response criteria. |
| Secondary | Clinical benefit rate (Arms A, B, and C) | Up to 2 years | Will be estimated in each arm by the number of patients who achieve a CR, PR, minor response (MR), or stable disease (SD) on the cycle 2 response assessment divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated. The clinical benefit rate will be compared between the DLBCL arms using the chi-square test (or Fisher's exact test if the data in the contingency table is sparse). |
| Secondary | Overall survival | From registration to death due to any cause, assessed up to 2 years | The distribution of overall survival will be estimated in each arm using the method of Kaplan-Meier. In the DLBCL arms, the comparison of overall survival between the two treatment arms will be based on the log-rank test. |
| Secondary | Progression-free survival | From date of first treatment to the earliest date of documentation of disease progression or death due to any cause, assessed up to 2 years | The distribution of progression-free survival will be estimated in each arm using the method of Kaplan-Meier. In the DLBCL arms, the comparison of progression-free survival between the two treatment arms will be based on the log-rank test. |
| Secondary | Percent of transplant eligible patients proceeding to transplant (Arms A, B and C) | Up to 2 years | Will be estimated in each arm by the number of patients proceeding to transplant divided by the total number of patients who were considered transplant eligible. Exact binomial 95% confidence intervals for the true success rate will be calculated. The rate will be compared between the DLBCL arms using the chi-square test (or Fisher's exact test if the data in the contingency table is sparse). |
| Secondary | Transfusion dependency (Arm D) | Up to 2 years | Transfusion dependency will be summarized descriptively. The number of patients transfusion dependent at baseline and during follow-up will be summarized. |
| Secondary | Incidence of adverse events | Up to 2 years | Assessed using Common Terminology Criteria for Adverse Events (CTCAE). The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. In the DLBCL arms, the overall adverse event rates for Grade 3 or higher hematologic and non-hematologic adverse events at least possibly related to treatment will be compared between the two treatment groups using the chi-square test (or Fisher's exact test if the data in the contingency table is sparse). The rate of febrile neutropenia will be evaluated in each arm. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39352751 | DERIVED |
Source PubMed
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | NIH RePORTER |
| P50CA097274 | Lymphoma Specialized Program of Research Excellence (SPORE) in Human Cancer | WEINER, GEORGE J.; WITZIG, THOMAS E. | UNIVERSITY OF IOWA | NATIONAL CANCER INSTITUTE | 2002 to 2021 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03418038
GET https://conductscience.org/api/trials/v1/NCT03418038/registered