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Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

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. Identifier: NCT00003746
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: 2-chlorodeoxyadenosine (CDA) daily Drug: 2-chlorodeoxyadenosine weekly Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
Study Start Date : September 1998
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Cladribine

Arm Intervention/treatment
Active Comparator: CDA day
CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
Drug: 2-chlorodeoxyadenosine (CDA) daily
Daily administration

Active Comparator: CDA week
CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
Drug: 2-chlorodeoxyadenosine weekly
Weekly administration

Primary Outcome Measures :
  1. Acute hematotoxicity at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  2. Acute infection rate at 10 weeks following study treatment [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Hospital admission frequency and length at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  2. Blood support at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  3. Remission rate [ Time Frame: 10 weeks ]
  4. Remission duration [ Time Frame: 10 weeks ]
  5. Relapse-free survival [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed classic form or prolymphocytic variant hairy cell leukemia (HCL)
  • Newly diagnosed HCL or progressive disease after prior treatment



  • 18 and over

Performance status:

  • NCI 0-2

Life expectancy:

  • At least 3 months


  • Not specified


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.3 mg/dL


  • 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


  • At least 4 weeks since any prior therapy and recovered

Biologic therapy:

  • Not specified


  • No concurrent cytoreductive therapy
  • No prior cladribine

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

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 identifier (NCT number): NCT00003746

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Inselspital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
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Study Chair: Reinhard Zenhaeusern, MD University Hospital Inselspital, Berne
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research Identifier: NCT00003746    
Other Study ID Numbers: SAKK 32/98
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Keywords provided by Swiss Group for Clinical Cancer Research:
untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
Additional relevant MeSH terms:
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Leukemia, Hairy Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs