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.
Sponsor:
Collaborators:
GlaxoSmithKline
Celgene Corporation
Information provided by (Responsible Party):
Luciano J. Costa, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01123356
First received: May 4, 2010
Last updated: June 18, 2013
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Ofatumumab, Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm
Single arm, non randomized study
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

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123356

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Medical University of South Carolina
GlaxoSmithKline
Celgene Corporation
  More Information

No publications provided

Responsible Party: Luciano J. Costa, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01123356     History of Changes
Other Study ID Numbers: 101376 OFT113297
Study First Received: May 4, 2010
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical University of South Carolina:
Relapsed chronic lymphocytic leukemia

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

ClinicalTrials.gov processed this record on September 22, 2014