Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Leukemia Clinical Trial

Official title:

Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003746
• Other study ID #: SAKK 32/98
• Secondary ID: SWS-SAKK-32/98EU
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: May 14, 2012
• Start date: September 1998
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2010
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Hairy Cell

Intervention

Drug:
• 2-chlorodeoxyadenosine (CDA) daily
Daily administration
• 2-chlorodeoxyadenosine weekly
Weekly administration

Locations

Country	Name	City	State
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Zenhäusern 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 phas — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute hematotoxicity at 10 weeks following study treatment		10 weeks	No
Primary	Acute infection rate at 10 weeks following study treatment		10 weeks	No
Secondary	Hospital admission frequency and length at 10 weeks following study treatment		10 weeks	No
Secondary	Blood support at 10 weeks following study treatment		10 weeks	No
Secondary	Remission rate		10 weeks	No
Secondary	Remission duration		10 weeks	No
Secondary	Relapse-free survival		10 weeks	No