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Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab
Lenalidomide
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring Relapsed chronic lymphocytic leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina
  • Greenville Hospital System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oratumumab and Lenalidomide

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency of Adverse and Severe Adverse Events
Frequency of adverse and severe adverse events
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.
Frequency of Adverse Events
Number of adverse events occuring in greater than 20% of subjects
Dose Reductions Due to Adverse Events.
Number of dose reductions due to toxicity.

Full Information

First Posted
May 4, 2010
Last Updated
November 2, 2015
Sponsor
Medical University of South Carolina
Collaborators
GlaxoSmithKline, Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01123356
Brief Title
Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab
Official Title
Phase 2 Trial of Intracycle Sequential Ofatumumab and Lenalidomide for the Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
GlaxoSmithKline, Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
Relapsed chronic lymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oratumumab and Lenalidomide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ofatumumab
Other Intervention Name(s)
Arzerra
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.
Time Frame
30 Weeks
Secondary Outcome Measure Information:
Title
Frequency of Adverse and Severe Adverse Events
Description
Frequency of adverse and severe adverse events
Time Frame
30 weeks
Title
Biomarkers Changes During Treatment.
Description
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.
Time Frame
30 Weeks
Title
Frequency of Adverse Events
Description
Number of adverse events occuring in greater than 20% of subjects
Time Frame
30 weeks
Title
Dose Reductions Due to Adverse Events.
Description
Number of dose reductions due to toxicity.
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Greenville Hospital System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Chronic Lymphocytic Leukemia in Patients Previously Exposed to Rituximab

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