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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003235-29 | EudraCT Number |
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The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.
Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy).
The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy.
The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 or the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and NHL.
Part B Cohort B will further evaluate the potential effects of food on the PK and safety of CC-99282.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose Escalation | Experimental |
| |
| Part B: Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-99282 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with laboratory abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with vital sign abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with electrocardiogram (ECG) abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Number of participants with physical examination abnormalities | From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years) | |
| Dose Limiting Toxicity (DLT) | Up to 28 days in Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Maximum plasma concentration of drug (Cmax) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) | |
| Pharmacokinetics - Area under the plasma concentration-time curve (AUC) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 109 | Scottsdale | Arizona | 85259 | United States | ||
| Local Institution - 111 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Rituximab | Drug | Specified dose on specified days |
|
| Obinutuzumab | Drug | Specified dose on specified days |
|
| Tafasitamab | Drug | Specified dose on specified days |
|
| Valemetostat | Drug | Specified dose on specified days |
|
| Maximum tolerated dose (MTD) | Up to 28 days in cycle 1 |
| Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) |
| Pharmacokinetics - Terminal-phase elimination half-life (T-HALF) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) |
| Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) |
| Pharmacokinetics: Apparent volume of distribution (Vz/F) | Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days) |
| Objective response rate (ORR) | Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR). Determined by the Lugano Classification for NHL response criteria | Up to approximately 6 years |
| Time to response (TTR) | Determined by the Lugano Classification for NHL response criteria | Up to approximately 6 years |
| Duration of response (DoR) | Determined by the Lugano Classification for NHL response criteria | Up to approximately 6 years |
| Progression free survival (PFS) | Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause Determined by the Lugano Classification for NHL response criteria | Up to approximately 6 years |
| Overall survival (OS) | Time from first dose of CC-99282 to death from any cause Determined by the Lugano Classification for NHL response criteria | Up to approximately 6 years |
| ORR | Defined as the percent of subjects whose best response is Complete Response (CR) or Partial Response (PR). Determined using the modified International PCNSL Collaborative Group (IPCG) criteria | Up to approximately 4 years |
| TTR | Determined using the modified International PCNSL Collaborative Group (IPCG) criteria | Up to approximately 4 years |
| DOR | Determined using the modified International PCNSL Collaborative Group (IPCG) criteria | Up to approximately 4 years |
| PFS | Determined using the modified International PCNSL Collaborative Group (IPCG) criteria | Up to approximately 4 years |
| OS | Determined using the modified International PCNSL Collaborative Group (IPCG) criteria | Up to approximately 4 years |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Local Institution - 102 | Tampa | Florida | 32207 | United States |
| Local Institution - 108 | Overland Park | Kansas | 66210 | United States |
| Local Institution - 107 | Rochester | Minnesota | 55905 | United States |
| Local Institution - 104 | St Louis | Missouri | 63110 | United States |
| Local Institution - 103 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 101 | Houston | Texas | 77030 | United States |
| Local Institution - 255 | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1118AAT | Argentina |
| Local Institution - 254 | Pilar | Buenos Aires | 1629 | Argentina |
| Local Institution - 253 | Buenos Aires | C1431FWO | Argentina |
| Local Institution - 701 | Salzburg | 5020 | Austria |
| Local Institution - 704 | Sankt Pölten | 3100 | Austria |
| Local Institution - 703 | Vienna | 1090 | Austria |
| Local Institution - 902 | Leuven | 3000 | Belgium |
| Local Institution - 453 | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Local Institution - 450 | São Paulo | São Paulo | 05651-901 | Brazil |
| Local Institution - 451 | São Paulo | 01401-002 | Brazil |
| Local Institution - 452 | São Paulo | 1246000 | Brazil |
| Local Institution - 201 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 354 | Santiago | Metropolitana de Santiago | 7580206 | Chile |
| Local Institution - 350 | Santiago | RM | 7560908 | Chile |
| Local Institution - 355 | Recoleta | Santiago Metropolitan | 842 0383 | Chile |
| Local Institution - 353 | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 352 | Santiago | Santiago Metropolitan | 8320000 | Chile |
| Local Institution - 653 | Beijing | Beijing Municipality | 100020 | China |
| Local Institution - 657 | Guangzhou | Guangdong | 510080 | China |
| Local Institution - 655 | Zhengzhou | Henan | 450000 | China |
| Local Institution - 660 | Wuhan | Hubei | 430079 | China |
| Local Institution - 662 | Shenyang | Liaoning | 110001 | China |
| Local Institution - 663 | Shenyang | Liaoning | 110022 | China |
| Local Institution - 650 | Shanghai | Shanghai Municipality | 200025 | China |
| Local Institution - 651 | Tianjin | Tianjin Municipality | 300060 | China |
| Local Institution - 659 | Guangzhou | 510060 | China |
| Local Institution - 602 | Aarhus | 8200 | Denmark |
| Local Institution - 601 | Copenhagen | 2100 | Denmark |
| Local Institution - 603 | Vejle | 7100 | Denmark |
| Local Institution - 407 | Bordeaux | 33076 | France |
| Local Institution - 403 | Créteil | 94010 | France |
| Local Institution - 406 | Lille | 59037 | France |
| Local Institution - 409 | Montpellier | 34295 | France |
| Local Institution - 405 | Paris | 75010 | France |
| Local Institution - 402 | Pierre-Bénite | 69495 | France |
| Local Institution - 404 | Rouen | 76038 | France |
| Local Institution - 408 | Toulouse | 31200 | France |
| Local Institution - 401 | Villejuif | 94805 | France |
| Local Institution - 150 | Jerusalem | 91120 | Israel |
| Local Institution - 151 | Petah Tikva | 49100 | Israel |
| Local Institution - 152 | Ramat Gan | 52621 | Israel |
| Local Institution - 501 | Bergamo | 24127 | Italy |
| Local Institution - 504 | Bologna | 40138 | Italy |
| Local Institution - 503 | Milan | 20162 | Italy |
| Local Institution - 502 | Naples | 80131 | Italy |
| Local Institution - 506 | Pavia | 27100 | Italy |
| Local Institution - 553 | Busan | 47392 | South Korea |
| Local Institution - 551 | Seoul | 03080 | South Korea |
| Local Institution - 550 | Seoul | 06351 | South Korea |
| Local Institution - 552 | Seoul | 06591 | South Korea |
| Local Institution - 306 | Badalona (Barcelona) | 08916 | Spain |
| Local Institution - 301 | Barcelona | 08035 | Spain |
| Local Institution - 302 | Madrid | 28040 | Spain |
| Local Institution - 304 | Madrid | 28046 | Spain |
| Local Institution - 303 | Málaga | 29010 | Spain |
| Local Institution - 305 | Salamanca | 37007 | Spain |
| Local Institution - 802 | Edinburgh Scotland | EH4 2XU | United Kingdom |
| Local Institution - 803 | Southhampton | SO01 6YD | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C543332 | obinutuzumab |
| C000613469 | tafasitamab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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