CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 551 enrolled
Drug / intervention
Allogeneic bone marrow transplantation +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Acute myelogenous leukemia in first, second, third or subsequent remission, or not in remission
  • ✓Acute lymphoblastic leukemia in first, second, third or subsequent remission, or not in remission
  • ✓Chronic myelogenous leukemia in chronic phase, accelerated phase, or blast phase
  • ✓Myelodysplastic syndromes including refractory anemia, refractory anemia with ringed sideroblasts, refractory cytopenia with multilineage dysplasia, refractory anemia with excess blasts, or MDS associated with isolated del(5q)
Key exclusion· 7
  • ✕Prior allogeneic or autologous stem cell transplantation (except prior autologous transplant for primary malignancy performed ≥12 months prior)
  • ✕Lymphoma, other malignant disorders, or non-malignant disorders as primary diagnosis
  • ✕Donor pregnant or uninterruptibly breastfeeding
  • ✕Donor with known allergy to G-CSF or E. coli-derived recombinant protein products

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00075816
NCT00075816Phase 3Completed
CompareCT.gov

A Phase III Randomized, Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell With Marrow Transplantation From Human Leukocyte Antigen (HLA) Compatible Unrelated Donors (BMT CTN #0201)

Medical College of Wisconsin·interventional·Posted Jan 13, 2004·Updated Jan 4, 2023

In Brief

A Phase 3 clinical trial evaluating Allogeneic bone marrow transplantation and Peripheral blood stem cell transplantation for Leukemia and 2 related conditions. Completed, enrolled 551 participants across 45 sites in 2 countries.

Detailed Summary

The study is designed as a Phase III, randomized, open label, multicenter, prospective, comparative trial of granulocyte colony stimulating factor (G-CSF)-mobilized peripheral blood stem cells (PBSC) versus marrow from unrelated donors for transplantation in patients with hematologic malignancies. Recipients will be stratified by transplant center and disease risk and will be randomized to either the PBSC or marrow arm in a 1:1 ratio.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloproliferative Disorders, Myelodysplastic-Myeloproliferative Diseases
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 13, 2004
Enrollment StartJan 1, 2004
Primary CompletionApr 1, 2013
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 22.5 years ago

Interventions

Allogeneic bone marrow transplantationbiological

Bone marrow transplant from HLA compatible unrelated donors.

Peripheral blood stem cell transplantationbiological

Peripheral blood transplant from HLA compatible unrelated donors.