- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003746
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if giving cladribine once a day is more effective than giving cladribine once a week in patients with hairy cell leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of cladribine given once a day to cladribine given once a week in treating patients with hairy cell leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the acute hematotoxicity and infection rate with daily and weekly administration of cladribine in patients with hairy cell leukemia.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive daily subcutaneous bolus injections of cladribine (2-CDA) for 5 days (standard dose).
- Arm II: Patients receive weekly subcutaneous bolus injections of 2-CDA for 5 weeks.
Patients showing complete or partial remission at evaluation on day 71 of the first treatment course do not receive any further treatment until relapse or disease progression is evident.
Patients showing minor or no response on day 71 of the first treatment course receive a subsequent course of standard dose 2-CDA.
Patients are followed every 3 months for 2 years, then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 4 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, CH-3010
- Inselspital Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL)
- Newly diagnosed HCL or progressive disease after prior treatment
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- NCI 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
Renal:
- Creatinine no greater than 2.3 mg/dL
Other:
- HIV negative
- Not pregnant
- No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin
PRIOR CONCURRENT THERAPY:
- At least 4 weeks since any prior therapy and recovered
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent cytoreductive therapy
- No prior cladribine
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CDA day
CDA:0.14 mg/kg/day Bolus s.c.
(standard) days 1-5
|
Daily administration
|
Active Comparator: CDA week
CDA:0.14 mg/kg/week Bolus s.c.
weeks 1-5
|
Weekly administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Acute hematotoxicity at 10 weeks following study treatment
Time Frame: 10 weeks
|
10 weeks
|
Acute infection rate at 10 weeks following study treatment
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital admission frequency and length at 10 weeks following study treatment
Time Frame: 10 weeks
|
10 weeks
|
Blood support at 10 weeks following study treatment
Time Frame: 10 weeks
|
10 weeks
|
Remission rate
Time Frame: 10 weeks
|
10 weeks
|
Remission duration
Time Frame: 10 weeks
|
10 weeks
|
Relapse-free survival
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Reinhard Zenhaeusern, MD, University Hospital Inselspital, Berne
Publications and helpful links
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAKK 32/98
- SWS-SAKK-32/98
- EU-98074
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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