Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003746
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Leukemia
Drug: 2-chlorodeoxyadenosine (CDA) daily
Drug: 2-chlorodeoxyadenosine weekly
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Acute hematotoxicity at 10 weeks following study treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Acute infection rate at 10 weeks following study treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital admission frequency and length at 10 weeks following study treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Blood support at 10 weeks following study treatment [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Remission rate [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Remission duration [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Relapse-free survival [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 1998
Study Completion Date: November 2010
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003746

Locations
Switzerland
Inselspital Bern
Bern, Switzerland, CH-3010
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Reinhard Zenhaeusern, MD University Hospital Inselspital, Berne
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00003746     History of Changes
Other Study ID Numbers: SAKK 32/98, SWS-SAKK-32/98, EU-98074
Study First Received: November 1, 1999
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

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:
Leukemia
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cladribine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014