NCT00144092

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2001

Longer than P75 for phase_2

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

May 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 21, 2011

Status Verified

August 1, 2011

First QC Date

September 1, 2005

Last Update Submit

November 18, 2011

Conditions

Low Grade Lymphoma

Keywords

autologous and allogeneic stem cell transplantationlow grade lymphomamantle cell

Outcome Measures

Primary Outcomes (4)

  • feasibility

  • mortality

  • overall survival

  • event free survival

Interventions

stem cell sourcePROCEDURE

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • pregnant lactating HIV positive CNS involvement by lymphoma other malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Related Publications (1)

  • Stewart DA, Duan Q, Carlson L, Russell JA, Bahlis NJ, Duggan P, Hasegawa W, Voralia M. A prospective phase II study of RICE re-induction, then high-dose fludarabine and busulfan, followed by autologous or allogeneic blood stem cell transplantation for indolent b-cell lymphoma. Clin Lymphoma Myeloma Leuk. 2011 Dec;11(6):475-82. doi: 10.1016/j.clml.2011.06.012. Epub 2011 Aug 10.

    PMID: 21831743DERIVED

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Doug Stewart

    Alberta Cancer Board - TBCC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Study Start

May 1, 2001

Study Completion

June 1, 2010

Last Updated

November 21, 2011

Record last verified: 2011-08

Locations

CA(1)