Back to resultsA Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
Primary Purpose
Lymphoma, Non-Hodgkin
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-99282
Rituximab
Obinutuzumab
Tafasitamab
Valemetostat
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Non-Hodgkin Lymphomas (NHL), Safety, Efficacy, CC-99282, Rituximab, Relapsed, Refractory, Pharmacokinetics, Obinutuzumab, Tafasitamab, Valemetostat, Anti-lymphoma agents
Eligibility Criteria
Inclusion Criteria:
- History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
- Life expectancy ≤ 2 months
- Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
- Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
- Impaired cardiac function or clinically significant cardiac disease
Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Mayo Clinic Arizona - ScottsdaleRecruiting
- UCSD Moores Cancer Center
- Local Institution - 114
- University of California, Irvine
- Oncology Institute of Hope and Innovation
- Mayo Clinic - JacksonvilleRecruiting
- H Lee Moffitt Cancer CenterRecruiting
- The University of Kansas - Clinical Research Center
- The University of Kansas - Clinical Research Center
- University Of Maryland At Baltimore
- Mayo Clinic in Rochester, Minnesota
- Mayo Clinic in Rochester, MinnesotaRecruiting
- Washington University
- Hackensack University Medical CenterRecruiting
- Perlmutter Cancer Center at NYU Langone Hospital-Long Island
- MD Anderson Cancer CenterRecruiting
- Local Institution - 255
- Local Institution - 251
- Local Institution - 254
- Local Institution - 250
- Local Institution - 253
- Local Institution - 252
- Local Institution - 701Recruiting
- Local Institution - 704Recruiting
- Local Institution - 703Recruiting
- Local Institution - 903
- Local Institution - 902Recruiting
- Local Institution - 453Recruiting
- Local Institution - 450Recruiting
- Local Institution - 451Recruiting
- Local Institution - 452Recruiting
- Local Institution - 203
- Local Institution - 201Recruiting
- Local Institution - 355
- Local Institution - 354
- Local Institution - 353Recruiting
- Local Institution - 352Recruiting
- Local Institution - 350Recruiting
- Local Institution - 0909
- Local Institution - 351
- Local Institution - 653
- Local Institution - 656
- Local Institution - 657
- Local Institution - 652
- Local Institution - 655
- Local Institution - 660
- Local Institution - 662
- Local Institution - 663
- Local Institution - 650
- Local Institution - 651
- Local Institution - 654
- Local Institution - 659
- Local Institution - 658
- Local Institution - 602Recruiting
- Local Institution - 601Recruiting
- Local Institution - 603Recruiting
- Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud OuestRecruiting
- Hopital Henri MondorRecruiting
- Chru De Lille - Hopital Claude HuriezRecruiting
- CHU Montpellier - Hôpital Saint EloiRecruiting
- Local Institution - 0904
- Hopital Saint-LouisRecruiting
- Centre Hospitalier Lyon-SudRecruiting
- Centre Henri BecquerelRecruiting
- Institut Claudius Regaud, IUCT-OncopoleRecruiting
- Gustave RoussyRecruiting
- Local Institution - 150Recruiting
- Local Institution - 151Recruiting
- Local Institution - 152Recruiting
- Local Institution - 501Recruiting
- Local Institution - 504Recruiting
- Local Institution - 503Recruiting
- Local Institution - 502Recruiting
- Local Institution - 506Recruiting
- Local Institution - 505
- Local Institution - 507
- Local Institution - 553Recruiting
- Local Institution - 551Recruiting
- Local Institution - 550Recruiting
- Local Institution - 552
- Local Institution - 306Recruiting
- Local Institution - 301Recruiting
- Local Institution - 302Recruiting
- Local Institution - 304Recruiting
- Local Institution - 303Recruiting
- Local Institution - 305Recruiting
- Local Institution - 0905
- Local Institution - 805
- Local Institution - 802Recruiting
- Local Institution - 803Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: Dose Escalation
Part B: Dose Expansion
Arm Description
Outcomes
Primary Outcome Measures
Incidence of Adverse Events (AEs)
Number of participants with laboratory abnormalities
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
Number of participants with physical examination abnormalities
Dose Limiting Toxicity (DLT)
Maximum tolerated dose (MTD)
Secondary Outcome Measures
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Pharmacokinetics: Apparent volume of distribution (Vz/F)
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
Time to response (TTR)
Determined by the Lugano Classification for NHL response criteria
Duration of response (DoR)
Determined by the Lugano Classification for NHL response criteria
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
Overall survival (OS)
Time from first dose of CC-99282 to death from any cause
Determined by the Lugano Classification for NHL response criteria
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
TTR
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
DOR
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
PFS
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
OS
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03930953
Brief Title
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
Official Title
A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
April 17, 2026 (Anticipated)
Study Completion Date
April 18, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Non-Hodgkin Lymphomas (NHL), Safety, Efficacy, CC-99282, Rituximab, Relapsed, Refractory, Pharmacokinetics, Obinutuzumab, Tafasitamab, Valemetostat, Anti-lymphoma agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part A: Dose Escalation
Arm Type
Experimental
Arm Title
Part B: Dose Expansion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-99282
Other Intervention Name(s)
BMS-986369
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Tafasitamab
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Valemetostat
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with laboratory abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with vital sign abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with left ventricular ejection fraction (LVEF) assessment abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Number of participants with physical examination abnormalities
Time Frame
From the time of consent at screening until 28 days after the subject discontinued study treatment (up to 4 years)
Title
Dose Limiting Toxicity (DLT)
Time Frame
Up to 28 days in Cycle 1
Title
Maximum tolerated dose (MTD)
Time Frame
Up to 28 days in cycle 1
Secondary Outcome Measure Information:
Title
Pharmacokinetics - Maximum plasma concentration of drug (Cmax)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Pharmacokinetics - Area under the plasma concentration-time curve (AUC)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Pharmacokinetics - Time to peak (maximum) plasma concentration (Tmax)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Pharmacokinetics - Terminal-phase elimination half-life (T-HALF)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Pharmacokinetics - Apparent total body clearance of the drug from the plasma (CLT/F)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Pharmacokinetics: Apparent volume of distribution (Vz/F)
Time Frame
Cycle 1 to Cycle 4 Day 15 (each cycle is 28 days)
Title
Objective response rate (ORR)
Description
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
Time Frame
Up to approximately 6 years
Title
Time to response (TTR)
Description
Determined by the Lugano Classification for NHL response criteria
Time Frame
Up to approximately 6 years
Title
Duration of response (DoR)
Description
Determined by the Lugano Classification for NHL response criteria
Time Frame
Up to approximately 6 years
Title
Progression free survival (PFS)
Description
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
Time Frame
Up to approximately 6 years
Title
Overall survival (OS)
Description
Time from first dose of CC-99282 to death from any cause
Determined by the Lugano Classification for NHL response criteria
Time Frame
Up to approximately 6 years
Title
ORR
Description
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
Time Frame
Up to approximately 4 years
Title
TTR
Description
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time Frame
Up to approximately 4 years
Title
DOR
Description
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time Frame
Up to approximately 4 years
Title
PFS
Description
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time Frame
Up to approximately 4 years
Title
OS
Description
Determined using the modified International PCNSL Collaborative Group (IPCG) criteria
Time Frame
Up to approximately 4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Exclusion Criteria:
Life expectancy ≤ 2 months
Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
Impaired cardiac function or clinically significant cardiac disease
Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Munoz, Site 109
Phone
480-203-6378
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 114
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-1804
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 114
Facility Name
University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92848
Country
United States
Individual Site Status
Withdrawn
Facility Name
Oncology Institute of Hope and Innovation
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamad Alhaj Moustafa, Site 111
Facility Name
H Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Chavez, Site 102
Phone
813-745-8172
Facility Name
The University of Kansas - Clinical Research Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Withdrawn
Facility Name
The University of Kansas - Clinical Research Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Hoffmann, Site 108
Phone
913-574-2650
Facility Name
University Of Maryland At Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic in Rochester, Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Nowakowski, Site 107
Phone
507-266-4972
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Completed
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatyana Feldman, Site 103
Phone
973-699-2835
Facility Name
Perlmutter Cancer Center at NYU Langone Hospital-Long Island
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Withdrawn
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loretta Nastoupil, Site 101
Phone
713-745-4017
Facility Name
Local Institution - 255
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1118AAT
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 255
Facility Name
Local Institution - 251
City
Ciudad autónoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1280
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Local Institution - 254
City
Pilar
State/Province
Buenos Aires
ZIP/Postal Code
1629
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 254
Facility Name
Local Institution - 250
City
Buenos Aires
ZIP/Postal Code
C1426ANZ
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Local Institution - 253
City
Buenos Aires
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 253
Facility Name
Local Institution - 252
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Local Institution - 701
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 701
Facility Name
Local Institution - 704
City
Sankt Pölten
ZIP/Postal Code
3100
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 704
Facility Name
Local Institution - 703
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 703
Facility Name
Local Institution - 903
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
Local Institution - 902
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 902
Facility Name
Local Institution - 453
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 453
Facility Name
Local Institution - 450
City
Sao Paulo
State/Province
Sp
ZIP/Postal Code
05651-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 450
Facility Name
Local Institution - 451
City
São Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 451
Facility Name
Local Institution - 452
City
São Paulo
ZIP/Postal Code
1246000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 452
Facility Name
Local Institution - 203
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Local Institution - 201
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 201
Facility Name
Local Institution - 355
City
Recoleta
State/Province
Metropolitana
ZIP/Postal Code
842 0383
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 355
Facility Name
Local Institution - 354
City
Santiago de Chile
State/Province
Metropolitana
ZIP/Postal Code
7500653
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 354
Facility Name
Local Institution - 353
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 353
Facility Name
Local Institution - 352
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8320000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 352
Facility Name
Local Institution - 350
City
Santiago
State/Province
RM
ZIP/Postal Code
7560908
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 350
Facility Name
Local Institution - 0909
City
Santiago
ZIP/Postal Code
7591046
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Local Institution - 351
City
Santiago
ZIP/Postal Code
838-0455
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Local Institution - 653
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 653
Facility Name
Local Institution - 656
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 657
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 657
Facility Name
Local Institution - 652
City
Haerbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 655
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 655
Facility Name
Local Institution - 660
City
Wuhan Shi
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 660
Facility Name
Local Institution - 662
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 662
Facility Name
Local Institution - 663
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 663
Facility Name
Local Institution - 650
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 650
Facility Name
Local Institution - 651
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 651
Facility Name
Local Institution - 654
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 659
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 659
Facility Name
Local Institution - 658
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 602
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 602
Facility Name
Local Institution - 601
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 601
Facility Name
Local Institution - 603
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 603
Facility Name
Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fontanet Bijou, Site 407
Phone
+33556337801
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, Site 403
Phone
+33149812151
Facility Name
Chru De Lille - Hopital Claude Huriez
City
Lillie Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Morschhauser, Site 406
Phone
33320445713
Facility Name
CHU Montpellier - Hôpital Saint Eloi
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume Cartron, Site 409
Phone
+33675926918
Facility Name
Local Institution - 0904
City
Montpellier CEDEX 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Withdrawn
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Thieblemont, Site 405
Phone
33142499236
Facility Name
Centre Hospitalier Lyon-Sud
City
Pierre-Benite CEDEX
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Bachy, Site 402
Phone
33478862286
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice JARDIN, Site 404
Facility Name
Institut Claudius Regaud, IUCT-Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bories, Site 408
Phone
33531156514
Facility Name
Gustave Roussy
City
Villejuif CEDEX
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Ribrag, Site 401
Phone
33142114507
Facility Name
Local Institution - 150
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 150
Facility Name
Local Institution - 151
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 151
Facility Name
Local Institution - 152
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 152
Facility Name
Local Institution - 501
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 501
Facility Name
Local Institution - 504
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 504
Facility Name
Local Institution - 503
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 503
Facility Name
Local Institution - 502
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 502
Facility Name
Local Institution - 506
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 506
Facility Name
Local Institution - 505
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Local Institution - 507
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Local Institution - 553
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 553
Facility Name
Local Institution - 551
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 551
Facility Name
Local Institution - 550
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 550
Facility Name
Local Institution - 552
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 552
Facility Name
Local Institution - 306
City
Badalona (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 306
Facility Name
Local Institution - 301
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 301
Facility Name
Local Institution - 302
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 302
Facility Name
Local Institution - 304
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 304
Facility Name
Local Institution - 303
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 303
Facility Name
Local Institution - 305
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 305
Facility Name
Local Institution - 0905
City
Belfast Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Local Institution - 805
City
Belfast Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Local Institution - 802
City
Edinburgh Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 802
Facility Name
Local Institution - 803
City
Southhampton
ZIP/Postal Code
SO01 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 803
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
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