CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Fludarabine phosphate +9 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01760655
NCT01760655Phase 2Completed
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A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Hematologic Malignancies

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Jan 4, 2013·Updated Oct 30, 2025

In Brief

A Phase 2 clinical trial evaluating Fludarabine phosphate, Busulfan, and 8 other interventions for Acute Myeloid Leukemia With FLT3/ITD Mutation and 20 related conditions. Completed, enrolled 62 participants across 1 site.

Detailed Summary

This phase II trial studies reduced-intensity conditioning before donor stem cell transplant in treating patients with high-risk hematologic malignancies. Giving low-doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) before the transplant may help increase this effect.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With Gene Mutations, Acute Myeloid Leukemia With Inv(3) (q21.3;q26.2); GATA2, MECOM, Acute Myeloid Leukemia With t(6;9) (p23;q34.1); DEK-NUP214, Aplastic Anemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Follicular Lymphoma, Hodgkin Lymphoma, Myelodysplastic Syndrome, Myelofibrosis, Myeloid Leukemia, Non-Hodgkin Lymphoma, Plasma Cell Myeloma, Polycythemia Vera, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 4, 2013
Enrollment StartDec 24, 2012
Primary CompletionApr 15, 2022
Study CompletionDec 5, 2022
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 13.5 years ago

Interventions

Fludarabine phosphatedrug

Given IV

Busulfandrug

Given IV

Total-Body Irradiationradiation

Undergo TBI

Therapeutic Allogeneic Lymphocytesbiological

Undergo DLI

Cyclophosphamidedrug

Given IV

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic PBSCT

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic PBSCT

Tacrolimusdrug

Given IV

Mycophenolate Mofetildrug

Given IV

Laboratory Biomarker Analysisother

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