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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003274-31 | EudraCT Number |
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Business objectives have changed.
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The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986403 + Fludarabine + Cyclophosphamide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986403 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 2 years after BMS-986403 infusion | |
| Number of participants with serious adverse events (SAEs) | Up to 2 years after BMS-986403 infusion | |
| Number of participants with clinical laboratory abnormalities | Up to 2 years after BMS-986403 infusion | |
| Number of participants with dose-limiting toxicity (DLT) | Up to 2 years after BMS-986403 infusion | |
| Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period | Up to 2 years after BMS-986403 infusion | |
| Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period | Up to 2 years after BMS-986403 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Up to 2 years after BMS-986403 infusion | |
| Complete remission rate (CRR) | Up to 2 years after BMS-986403 infusion | |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0005 | Birmingham | Alabama | 35249 | United States | ||
| Local Institution - 0016 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Fludarabine |
| Drug |
Specified dose on specified days |
|
| Cyclophosphamide | Drug | Specified dose on specified days |
|
| Up to 2 years after BMS-986403 infusion |
| Duration of complete remission (DOCR) | Up to 2 years after BMS-986403 infusion |
| Time to response (TTR) | Up to 2 years after BMS-986403 infusion |
| Time to CR (TTCR) | Up to 2 years after BMS-986403 infusion |
| Progression free survival (PFS) | Up to 2 years after BMS-986403 infusion |
| Overall survival (OS) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) | Up to 2 years after BMS-986403 infusion |
| Pharmacokinetics by PCR: Area under the curve (AUC) | Up to 2 years after BMS-986403 infusion |
| Duarte |
| California |
| 91010 |
| United States |
| Local Institution - 0007 | Boston | Massachusetts | 02114 | United States |
| Local Institution - 0026 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0009 | Columbus | Ohio | 43210 | United States |
| Local Institution - 0002 | Seattle | Washington | 98109-4433 | United States |
| Local Institution - 0024 | Barcelona | 08035 | Spain |
| Local Institution | Madrid | 28040 | Spain |
| Local Institution | Salamanca | 37007 | Spain |
| ID | Term |
|---|---|
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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