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| Overall Recruitment Status: Study terminated early |
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| Official Title |
| A Phase 1b/3 Double-blind, Randomized, Active-controlled, 3-stage, Biomarker Adaptive Study of Tazemetostat or Placebo in Combination With Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma |
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| Region |
Sponsors |
| Hawaii |
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| Acronym |
KP IRB No. |
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1588413-1 |
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| Study Type |
Phase |
| Clinical Trial |
Phase I |
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| Study Population Description |
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| Purpose |
| This is a multicenter, double-blind, active-controlled, randomized, 3-stage, biomarker enrichment design featuring early futility stopping and sample-size re-estimation with safety run-in designed to evaluate the efficacy and safety of tazemetostat in combination with R2 in subjects with R/R FL, who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy. |
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| Detailed Description |
| Stage 1 is a safety run-in phase, stage 2 is an efficacy and safety phase for an assessment of the EZH2 Mutant Type population and overall FL population regardless of EZH2 mutation status, and optional stage 3 with efficacy and safety phase for subjects with EZH2 mutation. Stage 3 with Mutant Type population alone will be executed in case the
efficacy of the overall population in stage 2 fails whilst the efficacy of EZH2 Mutant Type is sufficiently promising. Stage 2 will include 2 futility interim analyses based on ORR for the first futility and PFS for the second one. In addition, there is a possible sample size re-estimation based on PFS. This is to ensure early detection of the presence/absence of clinical efficacy benefit as well as ensuring adequate powering based on the trial results to demonstrate a meaningful efficacy difference. |
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| Gender |
Age Limit |
| Male & Female |
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- Have voluntarily agreed to provide written informed consent and demonstrated willingness and ability to comply with all aspects of the protocol
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- Males or females are =18 years of age at the time of providing voluntary written informed consent
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- Life expectancy =3 months before enrollment
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- Subjects with a history of hepatitis B or C are eligible on the condition that subjects have adequate liver function as defined by Inclusion Criterion #15 and are hepatitis B surface antigen negative and/or have undetectable hepatitis C virus (HCV) RNA
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- Have histologically confirmed FL, grades 1 to 3A.
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- Prior exposure to tazemetostat or other inhibitor(s) of EZH2
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- Prior exposure to lenalidomide for the treatment of FL
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- 3. Subjects who have mixed or transformed histology
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- Has thrombocytopenia, neutropenia, or anemia of grade =3 (per CTCAE Version 5.0 criteria) or any prior
history of myeloid malignancies, including myelodysplastic syndrome (MDS)
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- Has a prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (TALL).
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