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):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01123356
First received: May 4, 2010
Last updated: November 2, 2015
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
Drug: 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. Response was categorized according to the IW-CLL criteria which includes the following: Complete remission (CR), CR with incomplete marrow recovery (CRi)Partial remission (PR), Progressive disease (PD), Stable disease (SD).

    Overall response rate was defined as those who experienced a response of CR, CRi or PR.



Secondary Outcome Measures:
  • Frequency of Adverse and Severe Adverse Events [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
    Frequency of adverse and severe adverse events

  • Biomarkers Changes During Treatment. [ Time Frame: 30 Weeks ] [ Designated as safety issue: No ]
    Biomarkers changes during treatment. A minimum of 5 subjects will be enrolled in the biomarkers sub-study. Only those subjects enrolled at MUSC will be considered for the biomarkers sub-study. At day 1 of cycle 1, day 8 of cycle 1, day 1 of cycle 2 and day 8 of cycles 2, blood samples will be obtained for assessment of biomarkers.

  • Frequency of Adverse Events [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
    Number of adverse events occuring in greater than 20% of subjects

  • Dose Reductions Due to Adverse Events. [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
    Number of dose reductions due to toxicity.


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: Oratumumab and Lenalidomide

Single arm, non randomized study

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
Drug: Ofatumumab
  • Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
  • Treatment to be administered for up to 6 cycles
Other Name: Arzerra
Drug: Lenalidomide
-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)
Other Name: Revlimid

  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).
  2. Prior therapy with at least one regimen containing rituximab
  3. Age > 18 years.
  4. Life expectancy greater than 12 months.
  5. ECOG performance status <2
  6. Patients must have normal organ function as defined in the protocol.
  7. Patients must have adequate bone marrow function as defined in the protocol.
  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.
  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.
  5. Pregnant women are excluded from this study because lenalidomide is believed to be teratogenic.
  6. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ofatumumab or lenalidomide.
  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 and may or may not be eligible based on the results as outlined in the protocol.
  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

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01123356     History of Changes
Other Study ID Numbers: 101376 OFT113297 
Study First Received: May 4, 2010
Results First Received: April 21, 2015
Last Updated: November 2, 2015
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
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Lenalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016