Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00003746

Enrollment

100

Registered

2003-01-27

Start date

1998-09-30

Completion date

2010-11-30

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

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

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.

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.

Interventions

DRUG2-chlorodeoxyadenosine weekly

Weekly administration

DRUG2-chlorodeoxyadenosine (CDA) daily

Daily administration

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Acute hematotoxicity at 10 weeks following study treatment	10 weeks
Acute infection rate at 10 weeks following study treatment	10 weeks

Secondary

Measure	Time frame
Remission rate	10 weeks
Hospital admission frequency and length at 10 weeks following study treatment	10 weeks
Relapse-free survival	10 weeks
Remission duration	10 weeks
Blood support at 10 weeks following study treatment	10 weeks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026