Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

NCT01123356 | Completed Phase 2 Results DMC

• 1 other identifier: 101376 OFT113297
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chronic Lymphocytic Leukemia

Keywords

Relapsed chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Frequency of Adverse and Severe Adverse Events

  30 weeks

• Biomarkers Changes During Treatment.

  30 Weeks

• Frequency of Adverse Events

  30 weeks

• Dose Reductions Due to Adverse Events.

  30 weeks

Study Arms (1)

Oratumumab and Lenalidomide

EXPERIMENTAL

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; Drug: Lenalidomide

Interventions

Ofatumumab DRUG

* 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

Also known as: Arzerra

Oratumumab and Lenalidomide

Lenalidomide DRUG

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

Also known as: Revlimid

Oratumumab and Lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have confirmed diagnosis of chronic lymphocytic leukemia (CLL).
• Prior therapy with at least one regimen containing rituximab
• Age \> 18 years.
• Life expectancy greater than 12 months.
• ECOG performance status \<2
• Patients must have normal organ function as defined in the protocol.
• Patients must have adequate bone marrow function as defined in the protocol.
• Ability to understand and the willingness to sign a written informed consent document.
• All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• 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.
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin.

You may not qualify if:

• 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.
• Patients may not be receiving any other investigational agents or other anti-cancer agents or treatments.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or lenalidomide.
• Uncontrolled concomitant illness.
• Pregnant women are excluded from this study because lenalidomide is believed to be teratogenic.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ofatumumab or lenalidomide.
• Prior treatment with lenalidomide
• Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome. Subjects may be enrolled upon correction of electrolyte abnormalities.
• All patients will undergo screening for hepatitis B and may or may not be eligible based on the results as outlined in the protocol.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• GlaxoSmithKline: collaborator
• Celgene Corporation: collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ofatumumab; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Clinical Trials Network Manager
• Organization: Medical University of South Carolina

adraleta@musc.edu

843-792-1753

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 14, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 3, 2015
• Results First Posted: December 3, 2015

Record last verified: 2012-07

Locations

US (2)