Trial · NCT03418038
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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. |
| Secondary | Incidence of adverse events | Up to 2 years | Assessed using Patient Reported Outcomes (PRO)-CTCAE (Arms A and B). PRO-CTCAE scores range from 0-4, with corresponding response choices for frequency (Never / Rarely / Occasionally / Frequently / Almost constantly), for severity (None / Mild / Moderate / Severe / Very severe) and interference (Not at all / A little bit / Somewhat / Quite a bit / Very much). The scores for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. PRO-CTCAE scores 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). |
| Secondary | Continued salvage therapy beyond cycle 2 (Arm A, B and C) | Up to 2 years | Will be assessed by evaluating the number of patients who achieve an improved response after cycle 4 compared to the cycle 2 assessment in patients who received additional cycles of ascorbic acid/placebo added to salvage therapy beyond cycle 2. In addition, the number of patients who changed salvage therapies after cycle 2 will be assessed. This analysis will be primarily descriptive. |
| Secondary | Clinical benefit rate (Arm E) | Up to 2 years | The rates of complete response, complete cytogenetic remission, partial remission, marrow response, and clinical benefit will be estimated by the number of patients with each response type divided by the number of evaluable patients. |
| Secondary | Hematologic response rate in Arm E | Up to 2 years | The rates of erythroid response, platelet response, neutrophil response, spleen response and symptom response will be estimated by the number of patients with each response type divided by the number of evaluable patients. |
| Other | Biomarker analysis on blood and tissue (Arms A, B, and C) | Baseline up to 2 years | Will consider the correlative research exploratory. |
| Other | Biomarker analysis (Arm D) | Baseline up to 2 years | Variant allele frequency (VAF), biomarkers levels from Olink study, values of the cytokines, endothelial dysfunction, inflammation markers and levels of 5mc/5hmc will be measured at baseline, after completion of treatment (at 20 weeks), and at one-year post-registration. Values will be summarized graphically and descriptively at each time point and changes across time will be explored. Due to small sample size, these correlative analyses will be considered exploratory. |
| Other | Molecular response (Arm D) | Up to 2 years | Defined as a 2 standard deviation reduction in VAF from baseline VAF. Exact binomial 95% confidence intervals for the true success rate will be calculated. |
| Other | TET2 activity (Arm D) | At baseline and weeks 12, 20, 52 | Values will be summarized graphically and descriptively at each time point and changes across time will be explored. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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