NCT00003746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at below P25 for phase_3 leukemia

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

7.2 years

First QC Date

November 1, 1999

Last Update Submit

May 14, 2012

Conditions

Leukemia

Keywords

untreated hairy cell leukemiaprogressive hairy cell leukemia, initial treatmentprolymphocytic leukemia

Outcome Measures

Primary Outcomes (2)

  • Acute hematotoxicity at 10 weeks following study treatment

    10 weeks

  • Acute infection rate at 10 weeks following study treatment

    10 weeks

Secondary Outcomes (5)

  • Hospital admission frequency and length at 10 weeks following study treatment

    10 weeks

  • Blood support at 10 weeks following study treatment

    10 weeks

  • Remission rate

    10 weeks

  • Remission duration

    10 weeks

  • Relapse-free survival

    10 weeks

Study Arms (2)

CDA day

ACTIVE COMPARATOR

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

Drug: 2-chlorodeoxyadenosine (CDA) daily

CDA week

ACTIVE COMPARATOR

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

Drug: 2-chlorodeoxyadenosine weekly

Interventions

2-chlorodeoxyadenosine (CDA) dailyDRUG

Daily administration

CDA day
2-chlorodeoxyadenosine weeklyDRUG

Weekly administration

CDA week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19672771RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Prolymphocytic

Interventions

Cladribine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

2-ChloroadenosineAdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDeoxyadenosinesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Reinhard Zenhaeusern, MD

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 1998

Primary Completion

November 1, 2005

Study Completion

November 1, 2010

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CH(1)