CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Fludarabine +8 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/NCT02566304
NCT02566304Phase 2Completed
CompareCT.gov

A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Oct 2, 2015·Updated Apr 24, 2025

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Total-Body Irradiation, and 7 other interventions for Acute Myeloid Leukemia and 14 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help 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). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Acute Myeloid Leukemia in Remission, Aplastic Anemia, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Indolent Non-Hodgkin Lymphoma, Malignant Neoplasm, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Plasma Cell Myeloma, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Ring Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 2, 2015
Enrollment StartNov 13, 2015
Primary CompletionFeb 13, 2024
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.8 years ago

Interventions

Fludarabinedrug

Given IV

Total-Body Irradiationradiation

Undergo TBI

T Cell-Depleted Donor Lymphocyte Infusionbiological

Undergo DLI

Cyclophosphamidedrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo PBSC transplant

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo PBSC transplant

Tacrolimusdrug

Given PO

Mycophenolate mofetildrug

Given IV

Laboratory Biomarker Analysisother

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