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Alkylating agents

A for Leukemia

Phase 1 & 2
Waitlist Available
Led By Sonali Chaudhury, MD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

The study proposes the use of Fludarabine, Busulfan, Anti Thymocyte Globulin Rabbit (ATG) and Total Body Irradiation as a preparative regimen before hematopoietic stem cell transplant from unrelated donor peripheral blood stem cells (PBSC). The hypothesis states that the 100 day mortality after this type of transplant will be significantly below the accepted standards, which is about 30% for unrelated donors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the toxicity (as measures by 100 day survival) after hematopoietic stem cell transplant from an unrelated donor with a novel preparative regimen.
Secondary outcome measures
To evaluate the incidence of acute and chronic graft-versus-host disease after hematopoietic stem cell transplant
To evaluate the relapse-free and overall survival after hematopoietic stem cell transplant with Fludarabine/Busulfan/ATG/TBI preparative regimen for pediatric patients with leukemia.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AExperimental Treatment4 Interventions
All patients on this trial will receive a conditioning regimen of Busulfan, Fludarabine, Anti-Thymocyte Globulin and Total Body Irradiation (400 cGy)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Antithymocyte immunoglobulin (rabbit)
FDA approved
Total Body Irradiation
2006
Completed Phase 3
~820
Busulfan
FDA approved

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
256 Previous Clinical Trials
5,187,850 Total Patients Enrolled
10 Trials studying Leukemia
1,314 Patients Enrolled for Leukemia
Sonali Chaudhury, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago
1 Previous Clinical Trials
101 Total Patients Enrolled
1 Trials studying Leukemia
101 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors
Sonali Chaudhury, MD 2008. "Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00679536.
All > Acute Myeloid Leukemia
~2 spots leftby Apr 2025
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