Trial · NCT05627245
Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
NCT05627245, Phase 1, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment. Trials, record NCT05627245. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05627245
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment
- NCT number
- NCT05627245
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 48 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Recurrent Follicular Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, Refractory Follicular Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma, Refractory Transformed Non-Hodgkin Lymphoma
- Interventions
- Belinostat, Biopsy Procedure, Biospecimen Collection, Computed Tomography, Pharmacokinetic Study, Positron Emission Tomography and Computed Tomography Scan, Tazemetostat
- First posted
- 2022-11-25
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (Dose escalation) | Up to end of cycle 1 (Cycles = 21 days) | Defined as the highest dose level at which \< 33% of the dose cohort (0 of 3 or 1 of 6) experience a dose-limiting toxicity in the first cycle. |
| Secondary | Disease response | Following cycle 2 and 6, and every 3-6 cycles, assessed up to 1 year after completion of study treatment | Will be assessed by positron emission tomography/computed tomography scan following cycle 2 and 6, and then every 3-6 cycles. Response will be defined by the Lugano Classification. |
| Secondary | Overall response rate | Up to 1 year after completion of study treatment | Defined as complete response + partial response. Will be estimated and the exact 95% confidence interval will be constructed based on binomial distribution. |
| Secondary | Progression-free survival | From time to enrollment to progression or death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method and compared by the log-rank test. |
| Secondary | Overall survival | From time to enrollment to death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method and compared by the log-rank test. |
| Secondary | Duration of response | From first response to relapse or death, assessed up to 1 year after completion of study treatment | Will be estimated by the Kaplan-Meier method. |
| Secondary | Total number of cycles | Up to 2 years | The mean and range will be calculated. |
| Secondary | Number of dose delays | Up to 2 years | The mean and range will be calculated. |
| Secondary | Number of dose reductions | Up to 2 years | The mean and range will be calculated. |
| Secondary | Pharmacokinetic profile for tazemetostat and belinostat | Cycle 1, day 1 (C1D1) (belinostat only) and C2D1 | Plasma concentrations of both tazemetostat and belinostat using area under the "concentration time" curve, maximum concentration, time to maximum concentration, and half-life will be calculated for the two study drugs. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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 |
|---|---|---|---|---|---|
| UM1CA186689 | VICKtOrY Early Clinical Trials Consortium | LORUSSO, PATRICIA M. | YALE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 |
Source 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/NCT05627245
GET https://conductscience.org/api/trials/v1/NCT05627245/registered