- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00466895
Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Study Overview
Status
Intervention / Treatment
Detailed Description
Rationale:
Lenalidomide has properties of thalidomide and appears to have some activity against cancer in laboratory tests. Researchers are still learning how lenalidomide works against cancer in patients. Some ways that this drug seems to produce anti-cancer effects include through stimulating the immune system and blocking blood vessels contributing to cancer growth. The current study will explore different dose levels in patients to gather more information about lenalidomide.
Purpose:
This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects within patients will also be evaluated. Other purposes of this study include analyzing preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics refers to the activity of drugs in the body over a period of time, including how drugs are absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the bodily processes that lead the drug to effect cancer and other cellular components in the body.
Treatment:
Study participants will be given lenalidomide through intravenous infusions once every 28 days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated dose of lenalidomide, some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study. Each group of 3 to 6 study participants will receive a higher dose of lenalidomide until the maximum tolerated dose is established. Several tests will be performed throughout the study, including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be discontinued due to disease growth or intolerable adverse effects. Lenalidomide administration will be repeated for 12 or more cycles in patients that experience clinical benefit.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Blood blast count must be < 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count < 40,000/uL
- ECOG(Eastern Cooperative Oncology Group)performance status 0-2.
- Patients with CNS(central nervous system)involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF (cerebrospinal fluid)following intrathecal chemotherapy or radiation.
Exclusion Criteria:
- Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
- Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
- CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
- Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
- Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine >2.0 mg/dl Total bilirubin > 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST > 5 x upper limit of normal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stratum 1 Acute Leukemias
Patients must have a diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia(ALL)according to the WHO (World Health Organization) classification.
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Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21.
Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21.
Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21.
Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21.
Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
Other Names:
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Experimental: Stratum 2 Chronic lymphocytic leukemia
Patients must have diagnosis of B-Cell, Chronic Lymphocytic Leukemia(CLL) or Small Lymphocytic Leukemia (SLL) (including Waldenstrom's Macroglobulinemia) requiring therapy (see eligibility criteria for definition of this) and have previously received treatment with one or more prior chemotherapy regimens.
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Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21.
Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21.
Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21.
Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21.
Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Maximum tolerable dose
Time Frame: Every 2 weeks during cycle 1; Monthly during subsequent cycles
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Every 2 weeks during cycle 1; Monthly during subsequent cycles
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Toxicities of lenalidomide
Time Frame: Every 2 weeks during cycle 1; Monthly for subsequent cycles
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Every 2 weeks during cycle 1; Monthly for subsequent cycles
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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preliminary clinical activity
Time Frame: Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter
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Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter
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plasma and cellular pharmacokinetics
Time Frame: Days 1, 8, 15 and 21 of first cycle.
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Days 1, 8, 15 and 21 of first cycle.
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pharmacodynamics
Time Frame: Days 1, 8 and 26.
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Days 1, 8 and 26.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Leslie Andritsos, MD, Ohio State University
Publications and helpful links
General Publications
- Maddocks K, Ruppert AS, Browning R, Jones J, Flynn J, Kefauver C, Gao Y, Jiang Y, Rozewski DM, Poi M, Phelps MA, Harper E, Johnson AJ, Byrd JC, Andritsos LA. A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia. Leuk Res. 2014 Sep;38(9):1025-9. doi: 10.1016/j.leukres.2014.05.011. Epub 2014 May 29.
- Lapalombella R, Andritsos L, Liu Q, May SE, Browning R, Pham LV, Blum KA, Blum W, Ramanunni A, Raymond CA, Smith LL, Lehman A, Mo X, Jarjoura D, Chen CS, Ford R Jr, Rader C, Muthusamy N, Johnson AJ, Byrd JC. Lenalidomide treatment promotes CD154 expression on CLL cells and enhances production of antibodies by normal B cells through a PI3-kinase-dependent pathway. Blood. 2010 Apr 1;115(13):2619-29. doi: 10.1182/blood-2009-09-242438. Epub 2009 Nov 24.
- Fehniger TA, Byrd JC, Marcucci G, Abboud CN, Kefauver C, Payton JE, Vij R, Blum W. Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13. Blood. 2009 Jan 29;113(5):1002-5. doi: 10.1182/blood-2008-04-152678. Epub 2008 Sep 29.
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
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, B-Cell
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
Other Study ID Numbers
- OSU-06003
- NCI-2011-03218 (Other Identifier: CTRP (Clinical Trials Reporting Program))
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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