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Fludarabine Phosphate for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Ravi Vij
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This study is evaluating how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk myelodysplastic syndrome and older patients with acute myeloid

Eligible Conditions
  • Acute Myeloid Leukemia
  • Erythroleukemia
  • Acute Erythroid Leukemia
  • Myelodysplastic Syndrome
  • Acute Myelomonocytic Leukemia
  • Megakaryoblastic Leukemia
  • Monoblastic Leukemia
  • Monocytic 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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival
Secondary outcome measures
100-day Mortality
Overall Survival (OS)

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy and transplant)Experimental Treatment9 Interventions
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Methotrexate
2013
Completed Phase 4
~3800
Tacrolimus
2011
Completed Phase 4
~4740
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Anti-Thymocyte Globulin
2009
Completed Phase 4
~980
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,255 Total Patients Enrolled
Ravi VijPrincipal InvestigatorAlliance for Clinical Trials in Oncology

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
Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
2010. "Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01168219.
~5 spots leftby Apr 2025
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