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Treatment (RIC and allogeneic PBSCT) for Acute Myeloid Leukemia

Phase 2
Waitlist Available
Led By Dolores Grosso, RN, CRNP, DNP
Research Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post hsct
Awards & highlights

Study Summary

This trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Hodgkin's Lymphoma
  • Myelodysplastic Syndrome
  • Myelofibrosis
  • Myeloid Leukemia
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma
  • Acute Myelogenous Leukemia
  • Polycythemia Vera
  • Follicular Lymphoma
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myelomonocytic Leukemia

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival (DFS)
Secondary outcome measures
Engraftment rates
Immune reconstitution
Incidence and degree of graft versus host disease
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (RIC and allogeneic PBSCT)Experimental Treatment10 Interventions
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Busulfan
2008
Completed Phase 3
~1120
Total-Body Irradiation
1997
Completed Phase 3
~1180
Therapeutic Allogeneic Lymphocytes
1997
Completed Phase 2
~180
Fludarabine
FDA approved
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Tacrolimus
FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
10,849 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,210 Total Patients Enrolled
Dolores Grosso, RN, CRNP, DNPPrincipal InvestigatorThomas Jefferson University

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 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies
2012. "Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01760655.
~5 spots leftby Apr 2025
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