![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsors and Collaborators: |
University Health Network, Toronto Celgene Corporation |
---|---|
Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00751296 |
This study will assess the
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukaemia |
Drug: Lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL) |
Estimated Enrollment: | 27 |
Study Start Date: | August 2006 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
This is a phase II, nonrandomized, single institution study in symptomatic, previously untreated CLL patients. Subjects will receive the study drug, lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Although a maximal dose of 10 mg daily (days 1-21) will be targeted, if a patient is felt by the investigator to be benefiting from doses less than the target dose (i.e. 2.5 mg or 5 mg daily), the investigator may at his discretion choose to hold the patient at that dose without further escalation. For those patients who have progressive disease after cycle 3, further dose escalations as assessed by response and toxicity at the end of each escalated dose cycle to a maximum of 25 mg (days 1-21) will be allowed. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have symptomatic disease requiring therapy. One or more of the following must be present to be eligible:
Hematology: Absolute granulocytes (AGC) > 1.0 x 109/L Platelets > 50 x 109/L Chemistry: Serum creatinine < 1.5 x UNL Bilirubin < 1.5 x UNL AST (or ALT if AST < 2.5 x UNL not available)
Exclusion Criteria:
Responsible Party: | University Health Network ( Dr. Christine Chen / Hematologist ) |
Study ID Numbers: | Rev-06-0099, RV-CLL-PI-0099 |
Study First Received: | September 10, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00751296 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Lenalidomide immunomodulatory drug (IMiD®) Thalidomide analogues |
Lymphatic Diseases Leukemia Chronic Lymphocytic Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Thalidomide |
Leukemia, Lymphocytic, Chronic, B-Cell Lenalidomide Leukemia, B-cell, Chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Lenalidomide Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Leukemia, B-Cell Lymphoproliferative Disorders |