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Sponsor decision
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This study will investigate the efficacy and safety of MK-4827 in participants with relapsed mantle cell lymphoma (MCL) and in a subset of participants with inactivation of the Ataxia-Telangiectasia Mutated (ATM) gene.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-4827 | Experimental | All Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-4827 | Drug | MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who have a complete response (CR) or partial response (PR) during the study | Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with adverse events | From the day of enrollment through 30 days after the last dose of study drug | |
| Time from allocation to disease progression or death from any cause (Progression-free survival) | Tumor assessments will be performed every 9 weeks for the first year the participant is on treatment, every 12 weeks in year 2, and every 6 months in year 3 and beyond |
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Inclusion Criteria :
Exclusion Criteria :
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |