A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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ClinicalTrials.gov Identifier: NCT04434196 |
Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : January 20, 2021
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, Non-Hodgkin | Drug: CC-99282 Drug: Obinutuzumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1B, Multicenter, Open-label Study to Determine the Safety, Pharmacokinetics and Preliminary Efficacy of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
Actual Study Start Date : | December 21, 2020 |
Estimated Primary Completion Date : | June 10, 2024 |
Estimated Study Completion Date : | May 13, 2025 |

Arm | Intervention/treatment |
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Experimental: CC-99282 + obinutuzumab
Escalating doses of CC-99282 administered orally once daily on intermittent schedules with obinutuzumab IV infusion 1000 mg up to 2 years in Part A. CC-99282 administered orally once daily at MTD or alternative tolerating dosing schedule with obinutuzumab IV infusion 1000 mg up to 2 years in Part B.
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Drug: CC-99282
CC-99282 Drug: Obinutuzumab Obinutuzumab |
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Number of subjects with a DLT
- Maximum tolerated dose (MTD) [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days ]The highest dose of CC-99282 in combination with obinutuzumab associated with acceptable safety and tolerability
- Adverse Events (AEs) [ Time Frame: From first subjects first visit until 28 days after last subject discontinued study treatment ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
- Pharmacokinetics - Cmax [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Maximum observed plasma concentration
- Pharmacokinetics - AUC [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Area under the plasma concentration-time curve
- Pharmacokinetics - Tmax [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Time to Cmax
- Pharmacokinetics - t1/2 [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Terminal-phase elimination half-life
- Pharmacokinetics - CL/F [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Apparent total clearance of the drug from plasma after oral administration
- Pharmacokinetics - V/F [ Time Frame: Up to Cycle 2 Day 14 (each cycle is 28 days) ]Apparent volume of distribution during terminal phase after non-intravenous administration
- Objective response rate (ORR) [ Time Frame: Up to approximately 3 years ]Sum of complete response (CR), complete response with incomplete marrow recovery (CRi), nodular partial response (nPR), partial response (PR), partial response with lymphocytosis (PRL) determined by iwCLL criteria
- Duration of response (DoR) [ Time Frame: Up to approximately 3 years ]Time from first documentation of response (≥ PR) to the first documentation of PD or death
- Progression free survival [ Time Frame: Up to approximately 3 years ]Time from first dose of CC-99282 to the first occurrence of disease progression or death from any cause
- Overall survival [ Time Frame: Up to approximately 3 years ]Time from first dose of CC-99282 to death from any cause
- Complete response with incomplete marrow recovery (CRi) [ Time Frame: Up to approximately 3 years ]As assessed by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Nodular partial response (nPR) [ Time Frame: Up to approximately 3 years ]As assessed by iwCL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Partial response (PR) [ Time Frame: Up to approximately 3 years ]As assessed by iwC and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
- Partial response with lymphocytosis (PRL) [ Time Frame: Up to approximately 3 years ]As assessed by iwCLL and International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject is ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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Must have a documented diagnosis of CLL/SLL requiring treatment (IwCLL Guidelines for the Diagnosis and Treatment of CLL). In addition presence of clinically measurable disease determined by at least one of the factors listed:
- nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in longest perpendicular dimension (LPD), or
- spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum of 2 cm enlargement, or
- liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or
- peripheral blood B lymphocyte count > 5000/uL
- All eligible subjects must be relapsed after or be refractory to >2 prior lines of therapy one of which must have included an approved BTK inhibitor.
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Must meet the following laboratory parameters:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 or ≥ 1000 cells/mm3 if secondary to bone marrow involvement by disease.
- Platelet count ≥ 100,000 cells/mm3 (100 x 109/L) or ≥ 50,000 cells/mm3 (50 x 109/L) if secondary to bone marrow involvement by disease.
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) < 3.0 x upper limit of normal (ULN).
- Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome.
- Calculated creatinine clearance of ≥ 60 ml/min.
Exclusion Criteria:
- Presence of any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Prior allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of signing the ICD. Subjects who received allogeneic SCT ≥ 12 months before signing the ICD may be eligible provided there is no ongoing graft-versus-host disease and no ongoing immune suppression therapy.
- Subject has received prior CAR-T or other T-cell targeting treatment (approved or investigational) ≤ 4 weeks prior to starting CC-99282.
- Subject has received prior therapy with CRBN-modulating drug (eg, lenalidomide, avadomide/CC-122, pomalidomide) ≤ 4 weeks prior to starting CC-99282.
- History of second malignancies with life expectancy of ≤ 2 years or requirement of therapy that would confound study results.
- Peripheral neuropathy ≥ Grade 2.
- History of hypersensitivity to lenalidomide, pomalidomide, thalidomide.
- Impaired cardiac function or clinically significant cardiac disease.
- Persistent diarrhea or malabsorption ≥ NCI CTCAE Grade 2, despite medical management.
- Active disease transformation (ie, Richter's Syndrome)
- Uncontrolled/active autoimmune hemolytic anemia or thrombocytopenia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04434196
Contact: Associate Director Clinical Trial Disclosure | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
United States, Massachusetts | |
Dana Farber Cancer Institute | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Not yet recruiting |
New York, New York, United States, 10021 | |
United States, Ohio | |
The Ohio State University Comprehensive Cancer Center | Recruiting |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97201-3098 | |
United States, Texas | |
Southwestern Medical Center- Harold C Simmons Comprehensive Cancer Center | Not yet recruiting |
Dallas, Texas, United States, 75390 | |
Austria | |
Universitaetsklinik fuer Innere Medizin V | Not yet recruiting |
Innsbruck, Austria, 6020 | |
Landeskrankenhaus Salzburg | Recruiting |
Salzburg, Austria, 5020 | |
Allgemeinen Krankenhaus (AKH) Wien - Medizinische Universitaet Wien | Recruiting |
Wien, Austria, 1090 | |
Canada, Ontario | |
Princess Margaret Hospital University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Sir Mortimer B. Davis - Jewish Genl | Not yet recruiting |
Montreal, Quebec, Canada, H3T 1E2 | |
Spain | |
Hospital Universitario Vall D hebron | Recruiting |
Barcelona, Spain, 08035 | |
Hospital 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Clinica Universidad de Navarra | Recruiting |
Pamplona, Spain, 31008 | |
Universitario de Salamanca - Hospital Clinico | Recruiting |
Salamanca, Spain, 37007 | |
Hospital Clinico Universitario de Valencia | Recruiting |
Valencia, Spain, 46010 |
Study Director: | Poliana Patah, MD, PhD | Bristol-Myers Squibb |
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT04434196 |
Other Study ID Numbers: |
CC-99282-CLL-001 U1111-1251-4261 ( Other Identifier: WHO ) 2019-003228-18 ( EudraCT Number ) |
First Posted: | June 16, 2020 Key Record Dates |
Last Update Posted: | January 20, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | See Plan Description |
Access Criteria: | See Plan Description |
URL: | https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Safety Efficacy CC-99282 |
Obinutuzumab Relapsed Refractory |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Obinutuzumab Antineoplastic Agents, Immunological Antineoplastic Agents |