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Chemotherapy

Reduced-Intensity Conditioning for Myelodysplastic Syndrome

Phase 2
Waitlist Available
Led By Randy Windreich, MD
Research Sponsored by Randy Windreich
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 6 months
Awards & highlights

Study Summary

This trial is testing two different conditioning therapies for hematopoietic stem cell transplantation (HSCT). The goal is to reduce toxicity so that pediatric and young adult patients with high-risk AML/MDS can receive potentially life-saving treatment.

Eligible Conditions
  • Myelodysplastic Syndrome
  • Bone Marrow Transplant
  • Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preliminary efficacy (event-free survival at 6 months) in pediatric patients receiving a myeloablative or reduced-intensity preparative regimen prior to HSCT for high-risk AML and MDS.
Safety in pediatric patients receiving a myeloablative or reduced-intensity preparative regimen prior to HSCT for high-risk AML and MDS.
Secondary outcome measures
Day 0 Campath (Alemtuzumab) level
Incidence of Acute Graft Versus Host Disease (aGVHD) (II-IV, III-IV)
Incidence of Chronic Graft Versus Host Disease (cGVHD)
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Reduced-Intensity ConditioningActive Control1 Intervention
Campath (alemtuzumab), Droxia (hydroxyurea), Fludara (fludarabine), Alkeran (melphalan), Thiotepa (triethylenethiophosphoramide) Trade Name (generic name)
Group II: Myeloablative ConditioningActive Control1 Intervention
Campath (alemtuzumab), Thiotepa (triethylenethiophosphoramide) , Fludara (fludarabine), Busulfex (busulfan) Trade Name (generic name)

Find a Location

Who is running the clinical trial?

Randy WindreichLead Sponsor
Randy Windreich, MDPrincipal Investigator - University of Pittsburgh
Children's Hospital of Pittsburgh of UPMC
Tel Aviv University (Medical School)
Fairfax Hospital (Residency)

Media Library

Myeloablative Conditioning Regimen (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02626715 — Phase 2
Myelodysplastic Syndrome Research Study Groups: Reduced-Intensity Conditioning, Myeloablative Conditioning
Myelodysplastic Syndrome Clinical Trial 2023: Myeloablative Conditioning Regimen Highlights & Side Effects. Trial Name: NCT02626715 — Phase 2
Myeloablative Conditioning Regimen (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02626715 — Phase 2

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
Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS
Randy Windreich 2015. "Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02626715.
~2 spots leftby Apr 2025
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