search
Back to results

Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
2-chlorodeoxyadenosine (CDA) daily
2-chlorodeoxyadenosine weekly
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring untreated hairy cell leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inselspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CDA day

CDA week

Arm Description

CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5

CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5

Outcomes

Primary Outcome Measures

Acute hematotoxicity at 10 weeks following study treatment
Acute infection rate at 10 weeks following study treatment

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 1999
Last Updated
May 14, 2012
Sponsor
Swiss Group for Clinical Cancer Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00003746
Brief Title
Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia
Official Title
Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
untreated hairy cell leukemia, progressive hairy cell leukemia, initial treatment, prolymphocytic leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDA day
Arm Type
Active Comparator
Arm Description
CDA:0.14 mg/kg/day Bolus s.c. (standard) days 1-5
Arm Title
CDA week
Arm Type
Active Comparator
Arm Description
CDA:0.14 mg/kg/week Bolus s.c. weeks 1-5
Intervention Type
Drug
Intervention Name(s)
2-chlorodeoxyadenosine (CDA) daily
Intervention Description
Daily administration
Intervention Type
Drug
Intervention Name(s)
2-chlorodeoxyadenosine weekly
Intervention Description
Weekly administration
Primary Outcome Measure Information:
Title
Acute hematotoxicity at 10 weeks following study treatment
Time Frame
10 weeks
Title
Acute infection rate at 10 weeks following study treatment
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Hospital admission frequency and length at 10 weeks following study treatment
Time Frame
10 weeks
Title
Blood support at 10 weeks following study treatment
Time Frame
10 weeks
Title
Remission rate
Time Frame
10 weeks
Title
Remission duration
Time Frame
10 weeks
Title
Relapse-free survival
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Zenhaeusern, MD
Organizational Affiliation
Insel Gruppe AG, University Hospital Bern
Official's Role
Study Chair
Facility Information:
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19672771
Citation
Zenhausern 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 phase III trial (SAKK 32/98). Leuk Lymphoma. 2009 Sep;50(9):1501-11. doi: 10.1080/10428190903131755.
Results Reference
result

Learn more about this trial

Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

We'll reach out to this number within 24 hrs