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

This study has been completed.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00144092
First received: September 1, 2005
Last updated: November 18, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Low Grade Lymphoma
 Procedure: stem cell source
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Chemotherapy and Autologous or Allogeneic Blood Stem Cell Transplantation for Mantle Cell and Relapsed Low Grade Non-hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • feasibility
  • mortality
  • overall survival
  • event free survival

Estimated Enrollment: 60
Study Start Date: May 2001
Study Completion Date: June 2010
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144092

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Doug Stewart Alberta Cancer Board - TBCC
  More Information

No publications provided by Alberta Health Services

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00144092     History of Changes
Other Study ID Numbers: 147, 15841
Study First Received: September 1, 2005
Last Updated: November 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
autologous and allogeneic stem cell transplantation
low grade lymphoma
mantle cell

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013