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A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1/2 Study to Determine the Safety, Pharmacokinetics, and Efficacy of Single Agent CC-122 and the Combinations CC-122 AND Ibrutinib and CC-122 and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

NCT02406742•Celgene

View on ClinicalTrials.gov

Summary

Safety, pharmacokinetics, and preliminary efficacy of CC-122 alone and in combination with ibrutinib and obinuzutumab. CC-122 has multiple activities, including immune modulation of several immune cell subsets and antiproliferative activity in CLL. CC-122 has also been shown to have a tolerable safety profile with some preliminary signs of efficacy with early human experience.

Detailed Description

The primary objectives of this Phase 1/2 Study are to determine the safety of single agent CC-122 and the safety, tolerability, and RP2D of CC-122 when administered in combination with ibrutinib and in combination with obinutuzumab to subjects with CLL/SLL. The secondary objectives are to evaluate the PK profiles of subjects administered CC-122 in combination with ibrutinib and in combination with obinutuzumab, to determine ibrutinib concentrations when given alone and in combination with CC-122 and to evaluate the preliminary efficacy of CC-122 at selected dose levels/regimens.

Eligibility

Age

18 - 79 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects ≥ 18 years age and ≤ 80 years of age at the time of signing the informed consent form.
•2. Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Must have a documented diagnosis of CLL/ SLL requiring treatment (per IWCLL guidelines). In addition:
•a. Presence of at least one clinically measurable lesion: i. nodal lesion that measures ≥ 1.5 cm in longest dimension (LD) and ≥ 1.0 cm in longest perpendicular dimension (LPD), or ii. spleen that measures ≥ 14 cm in longest vertical dimension (LVD) with a minimum of 2 cm enlargement, or iii. liver that measures ≥ 20 cm in LVD with a minimum of 2 cm enlargement, or iv. peripheral blood B lymphocyte count \> 5000/uL.
•5. Must meet the criteria for relapsed and/or refractory disease according to the IWCLL guidelines (Hallek, 2008) to ≥ 1 prior treatment (with the exception of Arm B) and have evidence of disease progression requiring treatment at the time of study entry as follows:
•a. For Arms A and C, subjects must have received either prior chemoimmunotherapy or therapy with an approved BTK inhibitor with the following exceptions: i. Chemoimmunotherapy is not required if subjects have specific comorbidities that preclude the use of standard chemoimmunotherapy meeting at least 1 of the following criteria;
•1\. CIRS ≥ 6; 2. Creatinine Clearance \< 70 mL/min; 3. Subject is not a candidate for a chemoimmunotherapy in the opinion of investigator. ii. Treatment with an approved BTK inhibitor is not required if subject has contraindications or is not a candidate for such a therapy in the opinion of the investigator. b. For Arm B, subjects with treatment-naïve or R/R CLL must meet the following criteria: i. Dose Escalation Phase: Subjects must not have received prior treatment with ibrutinib (or any other approved BTK inhibitors) and must have either R/R CLL or treatment naïve (ie, first-line) CLL if the subject:
•1. has 17p- and/or TP53 mutation; or
•2. is unfit for standard chemoimmunotherapy meeting at least 1 of the following co-morbidity criteria: a. CIRS ≥ 6; b. Creatinine Clearance \< 70 mL/min; c. Subject is not a candidate for a chemoimmunotherapy in the opinion of the investigator. The reason for not being a candidate must be documented in CRF. ii. Dose Expansion Phase: Subjects must not have received prior treatment with ibrutinib (or any other approved BTK inhibitors) and must have high risk CLL. High risk is defined as: 1) 17p- and/or TP53 mutation positive in treatment naïve CLL; or 2) 17p- and/or TP53 mutation positive, and/or complex karyotype, and/or progression \< 24 months after completion of 1st line chemoimmunotherapy in R/R CLL c. Subjects with R/R SLL or CLL with bulky disease (at least one lymph node measuring \> 5.0 cm in diameter) are considered at higher risk for developing a TFR and may only be enrolled upon discussion with the sponsor's medical monitor and agreement to close medical management.
+31 more criteria

Exclusion Criteria

•1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
•2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
•3. Any condition that confounds the ability to interpret data from the study.
•4. Prior autologous or 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.
•5. Uncontrolled intercurrent illness including, but not limited to:
•1. Ongoing or active infection requiring parenteral antibiotics.
•2. Uncontrolled diabetes mellitus.
•i. The glycemic targets for subjects with diabetes should take into consideration age, comorbidities, life expectancy, and functional status of the subjects and follow established guidelines (eg, International Diabetes Federation, the European Diabetes Working Party guidelines, and the American Diabetes Association). For younger (\< 70 years old) or subjects with life expectancy ≥ 10 years, the target glycosylated hemoglobin, type A1C (HbA1c) should be \< 7.0%. The target HbA1c for older (≥ 70 years old) subjects or subjects with life expectancy \< 10 years should be \< 8.0%. Consultation with an endocrinologist is recommended when deciding if diabetes is optimally controlled.
•c. Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart Association Classification for Heart Disease). d. Active central nervous system involvement as documented by spinal fluid cytology or imaging. e. Uncontrolled autoimmune hemolytic anemia or thrombocytopenia. f. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with protocol.
•6. History of second malignancies with life expectancy of \< 2 years or requirement of therapy that would confound study results. This does not include the following:
+33 more criteria

Locations (24)

University of California San Diego

La Jolla, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Weill Cornell Medical College Dr. Feldman's Office

New York, New York, United States

Ohio State University Medical CenterJames Cancer Hospital

Columbus, Ohio, United States

The West Clinic

Memphis, Tennessee, United States

MD Anderson Cancer Center The University of Texas

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

University Hospital Innsbruck

Innsbruck, Austria

University Hospital of Salzburg St Johanns Spital

Salzburg, Austria

Key Dates

Start Date

July 27, 2015

Primary Completion Date

July 7, 2020

Completion Date

July 7, 2020

Last Updated

September 20, 2021

Enrollment

ACTUAL participants

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

CC-122

DRUG

Ibrutinib

DRUG

Obinutuzumab

DRUG

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Lymphoma, Non-HodgkinLeukemia, Lymphocytic, Chronic, B-Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Inclusion Criteria

Exclusion Criteria

Long-Term Safety of Pirtobrutinib in Participants With Previously Treated Types of Blood Cancers

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