Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123356
• Other study ID #: 101376 OFT113297
• Status: Completed
• Phase: Phase 2
• First received: May 4, 2010
• Last updated: November 2, 2015
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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
• Lenalidomide
-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Greenville Hospital System	Greenville	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Celgene Corporation, GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	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.	30 Weeks	No
Secondary	Frequency of Adverse and Severe Adverse Events	Frequency of adverse and severe adverse events	30 weeks	Yes
Secondary	Biomarkers Changes During Treatment.	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.	30 Weeks	No
Secondary	Frequency of Adverse Events	Number of adverse events occuring in greater than 20% of subjects	30 weeks	Yes
Secondary	Dose Reductions Due to Adverse Events.	Number of dose reductions due to toxicity.	30 weeks	Yes