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Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01732861
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : December 20, 2019
Information provided by (Responsible Party):

Brief Summary:
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).

Condition or disease Intervention/treatment Phase
Leukemia Lymphocytic Chronic B-Cell Drug: CC-292 Drug: Lenalidomide Phase 1

Detailed Description:
This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose. The starting dose is CC-292 375 mg twice daily and Lenalidomide 10 mg once daily. After review of the data for dose limiting toxicities (DLTs), the second dose level will be enrolled. Doses for this second cohort are CC-292 500 mg twice daily and lenalidomide 10 mg once daily. Additional doses of lenalidomide in combination with CC-292 may be evaluated to accurately determine the maximum tolerated dose. Once the maximum tolerated dose and/or optimal biologic effect has been ascertained, an expansion cohort of 24 subjects may be enrolled.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 28, 2012
Actual Primary Completion Date : January 23, 2019
Actual Study Completion Date : January 23, 2019

Arm Intervention/treatment
Experimental: CC-292 + Lenalidomide Drug: CC-292
CC-292-will be given twice daily on Days 8-28 of Cycle 1 and on Days 1-28 of the remaining 28-day cycles.

Drug: Lenalidomide
Lenalidomde will be given once daily on Days 1-28 of 28-day cycles.

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 5 years ]
    Number of participants with adverse events

Secondary Outcome Measures :
  1. Percentage of Participants Who Have Received Some Form of Response [ Time Frame: Up to 2 years ]
    Response rate is defined as the percentage of participants who have achieved some form of response including: a Complete Response (CR), a CR with incomplete bone marrow recovery, a Nodular Partial Response (PR), a Nodal PR or a PR with lymphoctyosis) based on the International Workshop for Chronic Lymphocytic Leukemia and lymphoma guidelines (IWCLL).

  2. PK-Cmax [ Time Frame: Up to 15 days ]
    Maximum observed plasma concentration

  3. PK-Tmax [ Time Frame: Up to 15 days ]
    Time to maximum observed plasma concentration

  4. PK-λz [ Time Frame: Up to 15 days ]
    Terminal phase rate constant, determined by linear regression of the terminal points of the log-linear plasma concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration

  5. PK-t1/2 [ Time Frame: Up to 15 days ]
    Estimate of the terminal elimination half-life in plasma

  6. PK-AUC (0-t) [ Time Frame: Up to 15 days ]
    Area under the plasma concentration-time curve from time zero to time t, where t is the last measurable time point

  7. PK-AUC0-∞ [ Time Frame: Up to 15 days ]
    Area under the plasma concentration time curve from time zero extrapolated to infinity.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and female subjects 18 years of age and older at the time of signing the informed consent document (ICD).
  • Body weight at least 50 kg.
  • Must have a documented diagnosis of CLL/SLL (International Workshop on Chronic Lymphocytic Leukemia IWCLL Guidelines - Hallek 2008) by investigator assessment.
  • Have failed at least 1 previous treatments for CLL/SLL, and have relapsed and/or refractory disease following last prior treatment defined as CLL/SLL that does not achieve at least a partial response (PR) to therapy or that progresses within 6 months of treatment.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 2 or less.
  • Life expectancy of at least 3 months from time of signing ICD.
  • Females of childbearing potential (FCBP) must have a negative medically supervised pregnancy test prior to starting study therapy and agree to ongoing pregnancy testing during and after end of study therapy; commit to continued abstinence from heterosexual intercourse or agree to use, comply with two effective methods of contraception without interruption, 28 days prior to starting study drug, during study therapy, and for 28 days after discontinuation of study therapy.
  • Male subjects must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy, throughout study drug therapy and dose interruption, and for 28 days after end of study therapy; agree to not donate semen or sperm during study drug therapy and for 28 days after end of study drug therapy.
  • All subjects must understand that lenalidomide could have a potential teratogenic risk, agree to abstain from donating blood with taking lenalidomide therapy and following discontinuation of study drug therapy; have an echocardiogram (ECG) or multigated acquisition (MUGA) scan of the heart demonstrating left ventricular ejection fraction (LVEF) at least 50% or the institution's lower limit of normal; have recovered from adverse, toxic effects of prior therapies to equal to or less than 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 except for alopecia and peripheral neuropathy.

Exclusion Criteria:

- Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.

  • Autologous stem cell transplant within 3 months prior to the time of signature on the ICD Informed Consent Document.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics; uncontrolled diabetes mellitus; chronic symptomatic congestive heart failure; unstable angina pectoris, angioplasty, stenting, or myocardial infarctions within 6 months prior to the time of signature on the ICD; clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Subjects with controlled atrial fibrillation that is asymptomatic are eligible.
  • Pregnant or lactating females.
  • Prior history of malignancies, unless the subject has been free of the disease for 5 years or more prior to the time of signature on the ICD. Exceptions to the 5 years or more time limit include history of basal cell carcinoma of the skin; squamous cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the breast; carcinoma in situ of the bladder; incidental histologic finding of prostate cancer (Tumor/Nodes/Metastasis [TNM] stage of T1a or T1b).
  • Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
  • Known seropositivity for hepatitis C virus (HCV); hepatitis B virus (HBV).
  • Subjects who are at a high risk for a thromboembolic event and are not willing/able to take venous thromboembolic event (VTE) prophylaxis.
  • Any of the following laboratory abnormalities:

    1. Absolute Neutrophil Count (ANC) ≤ 1,000 cells/mm3 (1.0 x 109/L)
    2. Platelet count ≤ 50,000/mm3 (50 x 109/L) unless secondary to bone marrow involvement by recent bone marrow aspiration and bone marrow biopsy
    3. Serum Aspartate Transaminase/Serum Glutamic-Oxaloacetic Transaminase (AST/SGOT) or Alanine Transaminase/Serum Glutamic-Pyruvic Transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN) or > 5.0 x ULN in cases of documented liver involvement
    4. Serum bilirubin > 1.5 x ULN or > 3.0 x ULN in cases of Gilbert's Syndrome and documented liver involvement by lymphoma;
    5. Calculated creatinine clearance using the Cockcroft-Gault formula (Cockcroft,1976)
    6. Corrected QT interval (QTc) prolongation (defined as a QTc > 450 msec for males and > 470 msec for females [Fridericia's correction]) or other clinically significant ECG abnormalities as assessed by the investigator.
  • Chemotherapy, radiotherapy, investigational anticancer therapy or major surgery within 28 days of Day 1 dosing.
  • Use of systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day within 3 weeks prior to study drug dosing.
  • Concomitant use of medicines known to cause QT prolongation or torsades de pointes.
  • Chronic use of H2 antagonists or proton pump inhibitors or their use within 7 days of first dose.
  • Gastrointestinal abnormalities including the inability to take oral medication, requiring intravenous alimentation, or prior surgical procedure affecting absorption.
  • Prior treatment with Btk (Bruton's tyrosine kinase) inhibitors.
  • Any live vaccinations within 3 weeks from first dose.
  • History of hypersensitivity to immunomodulatory drugs (IMiDs) (eg, lenalidomide, thalidomide, pomalidomide).
  • Disease transformation (ie, Richter's Syndrome [lymphomas] or prolymphocytic leukemia).
  • Patients with uncontrolled hyper or hypothyroidism.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01732861

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United States, Alabama
Clearview Cancer Institute Oncology Specialties, P.C
Huntsville, Alabama, United States, 35805
United States, Indiana
Horizon Oncology Center
Lafayette, Indiana, United States, 47905
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Universitatsklinik fur Innere Medizin
Innsbruck, Austria
AKh Linz
Linz, Austria, 4021
Universitatsklinik der PMU
Salzburg, Austria, 5020
Allgemeines Krankenhaus Wien
Wien, Austria, 1090
Medizinische Abteilung-Zentrum fur Onkologie und Hamatologie
Wien, Austria, 1100
Sponsors and Collaborators
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Study Director: David Liu, MD Celgene
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Responsible Party: Celgene Identifier: NCT01732861    
Other Study ID Numbers: CC-292-CLL-001
2012-003766-41 ( EudraCT Number )
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by Celgene:
Chronic Lymphocytic Leukemia
Small Lymphocytic Leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents