Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

This study has been completed.
Celgene Corporation
Information provided by (Responsible Party):
Luciano J. Costa, Medical University of South Carolina Identifier:
First received: May 4, 2010
Last updated: June 18, 2013
Last verified: July 2012

May 4, 2010
June 18, 2013
May 2010
May 2013   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 30 Weeks ] [ Designated as safety issue: No ]
Obtain early assessment of the efficacy of the intracycle sequential administration of ofatumumab and lenalidomide in the treatment of chronic lymphocytic leukemia (CLL) after prior use of rituximab
Overall response rate. [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01123356 on Archive Site
Frequency of adverse and severe adverse events, biomarkers changes during treatment [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of adverse and severe adverse events.
  • Biomarkers changes during treatment.
Same as current
Not Provided
Not Provided
Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab
Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

The purpose of this research is to evaluate the safety and effectiveness of the drugs lenalidomide and ofatumumab in the treatment of chronic lymphocytic leukemia (CLL).

Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Lymphocytic Leukemia
Drug: Ofatumumab, Lenalidomide
  • Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.
  • Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.
  • Treatment to be administered for up to 6 cycles
Other Name: Ofatumumab, Lenalidomide
Experimental: Single Arm
Single arm, non randomized study
Intervention: Drug: Ofatumumab, Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects must have confirmed diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry, including simultaneous expression of CD5, CD20 and CD23 with at least 10,000 CLL cells/mm3 in the patient peripheral blood at the time of enrollment
  2. Prior therapy with at least one regimen containing rituximab
  3. Age > 18 years. Because no dosing or adverse event data are currently available on the use of ofatumumab in combination with lenalidomide in patients <18 years of age, children are excluded from this study.
  4. Life expectancy greater than 12 months.
  5. ECOG performance status <2
  6. Patients must have normal organ function as defined below:

    • Total bilirubin <1.5 X normal institutional limits
    • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
    • Creatinine clearance >60 mL/min/1.73 m2 (Cockcroft-gault)
  7. Patients must have adequate bone marrow function defined as:

    • Absolute neutrophil count ≥ 1000/mm3
    • Platelet count ≥ 50,000/mm3
    • Hemoglobin ≥ 8.0 g/dl
  8. Ability to understand and the willingness to sign a written informed consent document.
  9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
  10. 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 and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse 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. 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. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
  11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

Exclusion Criteria:

  1. Patients who have had chemotherapy or radiotherapy within 4 weeks or received any monoclonal antibody within 6 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  2. Patients may not be receiving any other investigational agents or other anti-cancer agents or treatments.
  3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or lenalidomide.
  4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  5. Pregnant women are excluded from this study because lenalidomide is believed to be teratogenic. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ofatumumab or lenalidomide , breastfeeding should be discontinued if the mother is treated with ofatumumab or lenalidomide.
  6. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ofatumumab or lenalidomide. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive and/or potentially immunosuppressive therapy.
  7. Prior treatment with lenalidomide
  8. Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
  9. All patients will undergo screening for hepatitis B:

    • HbsAg positive- subject is excluded from the trial
    • HBsAg negative, HBcAb negative, HBsAb- subject is eligible.
    • HBsAg negative, HBcAb positive - HBV DNA must be performed
    • HBV DNA positive- subject is excluded
    • HBV DNA negative- subject is eligible, must undergo at least every 2 months HBV DNA PCR testing during treatment and at least every 3 months up to 6 months after the last treatment dose. Prophylactic antiviral therapy in addition to the monitoring described above, may be initiated at the discretion of the investigator.
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
101376 OFT113297
Luciano J. Costa, Medical University of South Carolina
Medical University of South Carolina
  • GlaxoSmithKline
  • Celgene Corporation
Not Provided
Medical University of South Carolina
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP