Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
NCT ID: NCT00003746
Last Updated: 2012-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
1998-09-30
2010-11-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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CDA day
CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
2-chlorodeoxyadenosine (CDA) daily
Daily administration
CDA week
CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
2-chlorodeoxyadenosine weekly
Weekly administration
Interventions
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2-chlorodeoxyadenosine (CDA) daily
Daily administration
2-chlorodeoxyadenosine weekly
Weekly administration
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Swiss Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Reinhard Zenhaeusern, MD
Role: STUDY_CHAIR
Insel Gruppe AG, University Hospital Bern
Locations
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Inselspital Bern
Bern, , Switzerland
Countries
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References
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Zenhausern R, Schmitz SF, Solenthaler M, Heim D, Meyer-Monard S, Hess U, Leoncini L, Bargetzi M, Rufener B, Tobler A. Randomized trial of daily versus weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98). Leuk Lymphoma. 2009 Sep;50(9):1501-11. doi: 10.1080/10428190903131755.
Other Identifiers
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SWS-SAKK-32/98
Identifier Type: -
Identifier Source: secondary_id
EU-98074
Identifier Type: -
Identifier Source: secondary_id
SAKK 32/98
Identifier Type: -
Identifier Source: org_study_id
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