Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00045513|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 23, 2015
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Lymphoma||Drug: 7-hydroxystaurosporine Drug: fludarabine phosphate||Phase 1 Phase 2|
- Determine the overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma treated with UCN-01 and fludarabine.
- Assess the molecular changes in CLL cells in peripheral blood in patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of UCN-01.
Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for the phase I portion of this study within 6 months. A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I/II Study Of UCN-01 In Combination With Fludarabine In Patients With Relapsed Or Refractory Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma|
|Study Start Date :||June 2002|
|Actual Primary Completion Date :||December 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045513
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 465|
|Princess Margaret Hospital at University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Michael R. Crump, MD, FRCPC||Princess Margaret Hospital, Canada|