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Alkylating agents

Allogeneic Transplantation for Pediatric Leukemias With Unrelated Donors

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 up to 5 years
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 5 Other Conditions

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.

Eligible Conditions
  • Leukemia

Timeline

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

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
Total Body Irradiation
2006
Completed Phase 3
~820
Antithymocyte immunoglobulin (rabbit)
FDA approved
Fludarabine
FDA approved
Busulfan
FDA approved

Find a Location

Who is running the clinical trial?

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
270 Previous Clinical Trials
5,182,070 Total Patients Enrolled
11 Trials studying Leukemia
1,338 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
~2 spots leftby Dec 2025
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