Clinical Trial: Daily or Weekly Cladribine in Treating Patients With Hairy Cell Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Daily Versus Weekly Administration of 2-Chlorodeoxyadenosine (CDA) in Patients With Hairy Cell 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 Summary:

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.


Sponsor: Swiss Group for Clinical Cancer Research

Current Primary Outcome:

  • Acute hematotoxicity at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  • Acute infection rate at 10 weeks following study treatment [ Time Frame: 10 weeks ]


Original Primary Outcome:

Current Secondary Outcome:

  • Hospital admission frequency and length at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  • Blood support at 10 weeks following study treatment [ Time Frame: 10 weeks ]
  • Remission rate [ Time Frame: 10 weeks ]
  • Remission duration [ Time Frame: 10 weeks ]
  • Relapse-free survival [ Time Frame: 10 weeks ]


Original Secondary Outcome:

Information By: Swiss Group for Clinical Cancer Research

Dates:
Date Received: November 1, 1999
Date Started: September 1998
Date Completion:
Last Updated: May 14, 2012
Last Verified: May 2012