Lenalidomide and Ofatumumab in Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: October 26, 2009
Last updated: April 6, 2015
Last verified: April 2015
The goal of this clinical research study is to learn if the combination of lenalidomide and ofatumumab can help to control CLL or SLL in patients who have already received therapy. The safety of this drug combination will also be studied.

Condition Intervention Phase
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Drug: Lenalidomide
Drug: Ofatumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Overall Response [ Time Frame: Responses assessed after 3, 6, 12, 18 and 24 cycles (each cycle is 28 days) and every 6-12 months as clinically indicated. ] [ Designated as safety issue: No ]
    Overall response includes complete remission (CR) and partial remission (PR). Patients are considered non-responders if there is progression of disease.

Estimated Enrollment: 36
Study Start Date: January 2010
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide + Ofatumumab
Lenalidomide 10 mg daily up to 24 cycles (cycle = 28 day); Ofatumumab IV infusions 300 mg week 1; 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24.
Drug: Lenalidomide
10 mg daily, started on day 9 (day after second infusion of ofatumumab) and continued daily through 24 cycles (cycle = 28 day)
Other Names:
  • CC-5013
  • Revlimid
Drug: Ofatumumab
4 weekly IV infusions of 300 mg week 1, 1,000 mg week 2, 3 and 4, then monthly during months 2-6 and once every two months during months 7-24 (even months: 8,10,12 etc.).

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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients age > 18 years at the time of signing informed consent. Understand and voluntarily sign an informed consent.
  2. Patients with CLL or SLL with active disease: B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the NCI-sponsored working group 1) weight loss of >10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy >5 cm in diameter.
  3. Prior treatment with purine analog based chemotherapy or chemoimmunotherapy.
  4. platelet count > or = to 30,000 mm3
  5. ECOG/WHO performance status of 0-2
  6. Adequate renal function indicated by creatinine clearance > 30ml/min (calculated by 24 hours urine collection) or a GFR > 30 ml/min estimated using the Cockcroft-Gault equation . Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and ALT less or equal to two times the upper limit of normal.
  7. Disease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received.
  8. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to starting lenalidomide and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and prior to first ofatumumab administration and must either commit to continued abstinence from heterosexual intercourse
  9. Cont. from #8 or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide and continue it for 6 months after therapy has been completed. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

  1. Known sensitivity to lenalidomide, other thalidomide derivatives or ofatumumab.
  2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
  3. Known positivity for HIV or active hepatitis B or C. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg positive but HBcAb positive regardless of HBsAg status, a HB DNA test will be performed and if positive the subject will be excluded.
  4. Pregnant or breast feeding females. Women of childbearing potential must have a negative pregnancy test at screening. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
  5. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis. History of tuberculosis treated within the last five years or recent exposure to tuberculosis.
  6. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study.
  7. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE), in the six months prior to enrollment are not eligible for this study.
  8. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
  9. Prior treatment with other monoclonal antibodies within 4 weeks prior to enrollment.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01002755

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Study Chair: Alessandra Ferrajoli, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01002755     History of Changes
Other Study ID Numbers: 2009-0283, NCI-2011-00398
Study First Received: October 26, 2009
Last Updated: April 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 30, 2015