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| A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| Clinicaltrials.gov identifier | recruitment status | First Posted | Last update posted |
| NCT05244070 | Recruiting | February 17, 2022 | July 8, 2022 |
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| study description |
| Brief Summary |
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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). |
| Condition or Disease: |
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma |
| Intervention/treatment: |
Drug: BMS-986403 Drug: Fludarabine Drug: Cyclophosphamide |
| Phase: | Phase 1 |
| Detailed Description |
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N/A |
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| study design | ||||||||||||||||||||||
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| Arms and interventions |
| Arm | Intervention/treatment |
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Experimental: BMS-986403 + Fludarabine + Cyclophosphamide |
Drug: BMS-986403 Specified dose on specified days Drug: Fludarabine Specified dose on specified days Drug: Cyclophosphamide Specified dose on specified days |
| outcome measures |
| Primary Outcome Measures: |
1. Number of participants with adverse events (AEs) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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3. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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4. Number of participants with dose-limiting toxicity (DLT) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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5. Maximum-tolerated dose (MTD) based on the incidence of DLTs that occur during the DLT evaluation period [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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6. Recommended Phase 2 Dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation period [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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| Secondary Outcome Measures: |
1. Overall response rate (ORR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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2. Complete remission rate (CRR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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3. Duration of response (DOR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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4. Duration of complete remission (DOCR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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5. Time to response (TTR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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6. Time to CR (TTCR) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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7. Progression free survival (PFS) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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8. Overall survival (OS) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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9. Pharmacokinetics by polymerase chain reaction (PCR): Maximum concentration (Cmax) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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10. Pharmacokinetics by PCR: Time to peak (maximum) concentration (Tmax) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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11. Pharmacokinetics by PCR: Area under the curve (AUC) [ Time Frame: Up to 2 years after BMS-986403 infusion ] |
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| Eligibility Criteria |
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Criteria |
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Inclusion Criteria: Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable) Exclusion Criteria: Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study Systemic fungal, bacterial, viral, or other infection that is not controlled Active autoimmune disease requiring immunosuppressive therapy Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen Other protocol-defined inclusion/exclusion criteria apply |
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| Contacts and Locations |
| Contacts |
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com Contact: First line of the email MUST contain the NCT# and Site #. |
| Locations |
| United States, Alabama | Local Institution | Birmingham |
| United States, California | Local Institution | Duarte |
| United States, Massachusetts | Local Institution | Boston |
| United States, New Jersey | John Theurer Cancer Center | Hackensack |
| United States, Ohio | University of Cincinnati Medical Center-University of Cincinnati Cancer Center | Cincinnati |
| United States, Ohio | Local Institution | Columbus |
| United States, Texas | Local Institution | Houston |
| United States, Washington | Local Institution | Seattle |
| United States, Wisconsin | Local Institution | Milwaukee |
| Canada, Alberta | Local Institution | Calgary |
| Canada, Nova Scotia | Local Institution | Halifax |
| Canada, Ontario | Local Institution | Toronto |
| France | Local Institution | Marseille |
| France | Local Institution | Rennes |
| France | Local Institution | Villejuif |
| Italy | Local Institution | Bergamo |
| Italy | Local Institution | Bologna |
| Italy | Local Institution | Milano |
| Spain | Local Institution | Barcelona |
| Spain | Local Institution | Madrid |
| Spain | Local Institution | Salamanca |
| United Kingdom | Local Institution | Cambridge |
| United Kingdom | Local Institution | Leeds |
| United Kingdom | Local Institution | London |
| United Kingdom | Local Institution | Manchester |
| Sponsors and Collaborators |
| Bristol-Myers Squibb |
| Investigator | ||
| Study Director : | Bristol-Myers Squibb | Bristol-Myers Squibb |
| More Information | ||||||||||||||
| Responsible Party : | Bristol-Myers Squibb | |||||||||||||
| ClinicalTrials.gov Identifier : | NCT05244070 | |||||||||||||
| Other Study ID Numbers : | CA097-001, 2021-003274-31 | |||||||||||||
| First Posted : | February 17, 2022 | |||||||||||||
| Last Update Posted : | July 8, 2022 | |||||||||||||
| Last Verified : | July 2022 | |||||||||||||
| Studies a U.S. FDA-regulated Drug Product: | Yes | |||||||||||||
| Studies a U.S. FDA-regulated Device Product: | No | |||||||||||||
| Keywords provided by Bristol-Myers Squibb: |
BMS-986403 Relapsed and/or Refractory Small Lymphocytic Lymphoma (CLL) Chronic Lymphocytic Leukemia (SLL) |
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| Additional relevant MeSH terms : |
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