Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia - Full Text View

Sponsored by:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003746

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: cladribine	Phase III

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cladribine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Acute hematotoxicity at 10 weeks following study treatment [ Designated as safety issue: Yes ]
Acute infection rate at 10 weeks following study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	120
Study Start Date:	September 1998

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

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000066865, SWS-SAKK-32/98, EU-98074
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003746
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

untreated hairy cell leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia

Study placed in the following topic categories:

Cladribine
Lymphatic Diseases
Leukemia
Leukemia, Hairy Cell
Immunoproliferative Disorders

Leukemia, Prolymphocytic
Prolymphocytic leukemia
Lymphoproliferative Disorders
Hairy cell leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009