HDCT and Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Low Grade Lymphoma Clinical Trial

Official title:

High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144092
• Other study ID #: 147
• Secondary ID: 15841
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: November 18, 2011
• Start date: May 2001
• Est. completion date: June 2010

Study information

• Verified date: August 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation.

Description:

Low grade lymphoma patients receive R-ICE reinduction therapy followed by allogeneic stem cell transplanation if they have an HLA matched sibling, or an autologous transplant if they do not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• indolent histology lymphomas after relapse 1 or 2 LVEF > 50% Creatinine < 150 umol/L bilirubin < 30 umol/L wbc >3.5X10^9/L platelets >100X10^9/L other medical condition as controlled

Exclusion Criteria:

• pregnant lactating HIV positive CNS involvement by lymphoma other malignancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Grade Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Procedure:
• stem cell source

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility
Primary	mortality
Primary	overall survival
Primary	event free survival