- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002755
Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate efficacy and tolerability of the combination of ofatumumab and lenalidomide in patients with recurrent chronic lymphocytic leukemia (CLL).
OUTLINE:
Participants receive ofatumumab intravenously (IV) over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide orally (PO) daily. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 6 months, then every 3 months thereafter.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Understand and voluntarily sign an informed consent
- Patients with CLL or small lymphocytic lymphoma (SLL) with active disease: B-CLL Rai III-IV or earlier stage disease with evidence of "active disease" as defined by the National Cancer Institute (NCI)-sponsored working group 1) weight loss of > 10% in prior 6 months, 2) extreme fatigue, 3) fever or night sweats without evidence of infection, 4) worsening anemia or thrombocytopenia, 5) progressive lymphocytosis with a rapid lymphocyte doubling time, 6) marked hypogammaglobulinemia or paraproteinemia, 7) lymphadenopathy > 5 cm in diameter
- Prior treatment with purine analog based chemotherapy or chemoimmunotherapy
- Platelet count > or = to 30,000 mm^3
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2
- Creatinine clearance > 30 ml/min (calculated by 24 hours urine collection) or a glomerular filtration rate (GFR) > 30 ml/min estimated using the Cockcroft-Gault equation
- Total bilirubin less or equal to 2 mg/dl
- Alanine aminotransferase (ALT) less or equal to two times the upper limit of normal
- Disease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received
- 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 starting lenalidomide and again within 24 hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and prior to first ofatumumab administration 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 and continue it for 6 months after therapy has been completed. 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. All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
Exclusion Criteria:
- Known sensitivity to lenalidomide, other thalidomide derivatives or ofatumumab
- Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
- Known positivity for human immunodeficiency virus (HIV) or active hepatitis B or C. Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg). In addition, if negative for HBsAg positive but HBcAb positive regardless of HBsAg status, a HB deoxyribonucleic acid (DNA) test will be performed and if positive the subject will be excluded
- Pregnant or breast feeding females. Women of childbearing potential must have a negative pregnancy test at screening. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis. History of tuberculosis treated within the last five years or recent exposure to tuberculosis
- Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study
- Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE), in the six months prior to enrollment are not eligible for this study
- Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
- Prior treatment with other monoclonal antibodies within 4 weeks prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (lenalidomide, ofatumumab)
Participants receive ofatumumab IV over 4 hours on days 1, 8, 15, and 22 of course 1, day 1 of courses 2-6, and day 1 of every even course beginning course 8. Beginning day 9 of course 1, participants also receive lenalidomide PO daily.
Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
|
Given PO
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate
Time Frame: Up to 8 years
|
A Simon's two-stage minmax design will be used.
Includes complete remission (CR) and partial remission (PR).
Complete Response Requires the absence of disease signs and symptoms, and normalization of Peripheral blood and bone marrow.
Partial Response it at lease a 50% reduction in disease signs and symptoms and normalization of peripheral blood.
|
Up to 8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Tolerance of the Medication Combination
Time Frame: Up to 8 years
|
Incidence of grade 3 and 4 non-hematological toxicity in more than 50 percent of the participants.
Will be monitored based on the Bayesian model (beta-binomial).
|
Up to 8 years
|
Progression Free Survival
Time Frame: Up to 8 years
|
The time from the start of therapy to death, disease progression, or the initiation of the next therapy.
Disease progression is the loss of response or transformation to a more aggressive histology.
|
Up to 8 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Hematologic Diseases
- Blood Protein Disorders
- Blood Platelet Disorders
- Leukocyte Disorders
- Leukemia, B-Cell
- Leukocytosis
- Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Thrombocytopenia
- Lymphadenopathy
- Paraproteinemias
- Agammaglobulinemia
- Lymphocytosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Ofatumumab
- Antibodies, Monoclonal
Other Study ID Numbers
- 2009-0283 (Other Identifier: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH Grant/Contract)
- NCI-2018-01829 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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