CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 158 enrolled
Drug / intervention
anti-thymocyte globulin +10 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00553202
NCT00553202Phase 2Completed

Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children's Oncology Group (COG) Study

Children's Oncology Group·interventional·Posted Nov 5, 2007·Updated Apr 16, 2020

In Brief

A Phase 2 clinical trial evaluating anti-thymocyte globulin, busulfan, and 9 other interventions for Leukemia. Completed, enrolled 158 participants across 52 sites in 2 countries.

Detailed Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may stop this from happening. PURPOSE: Natural Killer (NK) cells from the donor's bone marrow may be important in fighting leukemia. Bone marrow donors can be selected based on the type of NK cells they have, specifically the killer immunoglobulin receptor (KIR) type. This study provides information on KIR type from potential donors, which can be used in selecting the bone marrow donor. This phase II trial of unrelated donor stem cell transplant in patients with high risk AML (monosomy 7, -5/5q-, high FLT3-ITD AR, or refractory or relapsed AML) in which KIR typing of the patients and potential donors will be available to the treating transplant physician at the time of donor selection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 5, 2007
Enrollment StartJan 1, 2008
Primary CompletionJun 1, 2016
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 18.7 years ago

Interventions

anti-thymocyte globulinbiological

Given IV

busulfandrug

Given IV

cyclophosphamidedrug

Given IV

cyclosporinedrug

Given IV or orally

methotrexatedrug

Given IV

methylprednisolonedrug

Given IV

tacrolimusdrug

Given IV

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies

allogeneic bone marrow transplantationprocedure

allogeneic bone marrow transplantation

allogeneic hematopoietic stem cell transplantationprocedure

Undergo allogeneic hematopoietic SCT