Trial · NCT05205252
A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
NCT05205252, Phase 1, Phase 2, Withdrawn, Epizyme, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. Trials, record NCT05205252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05205252
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
- NCT number
- NCT05205252
- Status
- Withdrawn
- Phases
- Phase 1, Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Epizyme, Inc.
- Conditions
- Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy
- Interventions
- Tazemetostat, Tafasitamab, Lenalidomide, Acalabrutinib, Daratumumab (Intravenously), Mosunetuzumab, Daratumumab (Subcutaneously), Hyaluronidase-Fihj, Pomalidomide, Dexamethasone 20mg
- First posted
- 2022-01-25
- Last updated
- 2023-08-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug | Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b | The safety and tolerability of tazemetostat in combination with each partner drug in participants with R/R malignancies will be evaluated. RP2D of tazemetostat for further evaluation in phase 2 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs). |
| Primary | Phase 2: Objective Response Rate (ORR) | Time from the date of first dose of study drug to the time of response, assessed up to 24 months. | Overall response rate is defined as proportion of participants with a best response of at least partial remission (including partial remission and complete remission for participants with non-Hodgkin lymphoma in Arms 1, 2, 3, or 5 or partial remission, complete remission, stringent complete response, or very good partial response). |
| Secondary | Phase 2: Progression Free Survival (PFS) | Up to 24 months. | Progression free survival is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause. |
| Secondary | Time to response (TTR) | Up to 24 months | Defined as the time from the first dose of study drug to the earliest date of CR or PR per Lugano Classification (Arms 1, 2, 3, and 5) or sCR, CR, VGPR, or PR per IMWG 2016 criteria (Arm 4) as assessed by Investigator review. |
| Secondary | Phase 2: Duration of Response (DOR) | Up to 24 months | Duration of response is defined as the time from the initial response (at least partial remission) to documented disease progression. |
| Secondary | Phase 2: Disease control rate (DCR) | Up to 24 months | Defined as the percentage of participants who achieve complete response (CR), partial response (PR), or stable disease per Lugano Classification (Arms 1, 2, 3, or 5) or stringent complete response (sCR), CR, very good partial response (VGPR), PR, or stable disease per IMWG 2016 criteria (Arm 4) at 6 months on study treatment, as assessed by Investigator review. |
| Secondary | Phase 2: Overall Survival (OS) | Up to 24 months | Overall survival is defined as the time from the first dose of study drug to date of death due to any cause. |
| Secondary | Time to next treatment (TTNT) | Up to 24 months | Defined as the time from the first dose of study drug to the start of subsequent anticancer therapy |
| Secondary | Percentage of participants with Treatment Emergent Adverse Event (TEAEs) | Up to 24 months | An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Percentage of participants with clinically significant changes in laboratory parameters | Up to 24 months | Percentage of participants with clinically significant changes in laboratory parameters including, hematology, serum chemistry, coagulation and urinalysis will be reported. The clinical significance will be evaluated by the investigator. |
Source ClinicalTrials.gov
Outcomes0
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.
Grants0
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.
None in this release.
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/NCT05205252
GET https://conductscience.org/api/trials/v1/NCT05205252/registered