CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Fludarabine Phosphate +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/NCT01858740
NCT01858740Phase 2Completed
CompareCT.gov

A Phase II Study of Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children

Fred Hutchinson Cancer Center·interventional·Posted May 21, 2013·Updated Mar 12, 2024

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Fludarabine Phosphate, and 7 other interventions for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 17 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This phase II trial studies how well T cell depleted donor peripheral blood stem cell transplant works in preventing graft-versus-host disease in younger patients with high risk hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood 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. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing a subset of the T cells from the donor cells before transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Undifferentiated Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome With Excess Blasts-2, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Refractory Adult Acute Lymphoblastic Leukemia, Refractory Childhood Acute Lymphoblastic Leukemia
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 21, 2013
Enrollment StartApr 10, 2014
Primary CompletionJan 30, 2023
Study CompletionJul 30, 2023
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 13.1 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Methotrexatedrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant

T Cell-Depleted Hematopoietic Stem Cell Transplantationbiological

Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant

Tacrolimusdrug

Given IV or PO

Thiotepadrug

Given IV

Total-Body Irradiationradiation

Undergo TBI