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Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

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ClinicalTrials.gov Identifier: NCT00466895
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : November 14, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Leslie Andritsos, Ohio State University Comprehensive Cancer Center

April 26, 2007
April 27, 2007
November 14, 2017
April 2007
December 2014   (Final data collection date for primary outcome measure)
  • Maximum tolerable dose [ Time Frame: Every 2 weeks during cycle 1; Monthly during subsequent cycles ]
  • Toxicities of lenalidomide [ Time Frame: Every 2 weeks during cycle 1; Monthly for subsequent cycles ]
  • Maximum tolerable dose
  • Toxicities of lenalidomide
Complete list of historical versions of study NCT00466895 on ClinicalTrials.gov Archive Site
  • preliminary clinical activity [ Time Frame: Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter ]
  • plasma and cellular pharmacokinetics [ Time Frame: Days 1, 8, 15 and 21 of first cycle. ]
  • pharmacodynamics [ Time Frame: Days 1, 8 and 26. ]
  • preliminary clinical activity
  • plasma and cellular pharmacokinetics
  • pharmacodynamics
Not Provided
Not Provided
 
Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.
Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Chronic Lymphocytic Leukemia
Drug: lenalidomide
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 Name: Revlimid
  • 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.
    Intervention: Drug: lenalidomide
  • 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.
    Intervention: Drug: lenalidomide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
84
July 2016
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00466895
OSU-06003
NCI-2011-03218 ( Other Identifier: CTRP (Clinical Trials Reporting Program) )
Yes
Not Provided
Not Provided
Leslie Andritsos, Ohio State University Comprehensive Cancer Center
Leslie Andritsos
Celgene Corporation
Principal Investigator: Leslie Andritsos, MD Ohio State University
Ohio State University Comprehensive Cancer Center
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP