NCT00005074

Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma

A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.

Detailed description

OBJECTIVES: * Assess the efficacy of flavopiridol in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma. * Assess the toxicity of this regimen in this patient population. * Determine the time to progression and, if responses are observed, response duration in these patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive flavopiridol IV over 1 hour daily for 3 days. Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 2 additional courses after documented CR. Patients with a partial response receive 2 additional courses after documented maximal tumor shrinkage. Patients with stable disease receive a maximum of 4 courses. Patients are followed at 4 weeks and then every 3 months until relapse or death. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	alvocidib

Timeline

• Start date: 2000-01-24
• Primary completion: 2002-02-20
• Completion: 2008-09-22
• First posted: 2003-01-27
• Last updated: 2020-04-09

Locations

4 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study