CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Cyclophosphamide +7 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/NCT00723099
NCT00723099Phase 2Completed
CompareCT.gov

Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Reduced-Intensity Preparative Regimen (A Multi-Center Trial Coordinated by the FHCRC)

Fred Hutchinson Cancer Center·interventional·Posted Jul 28, 2008·Updated Dec 27, 2019

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and 6 other interventions for Acute Lymphoblastic Leukemia and 25 related conditions. Completed, enrolled 73 participants across 6 sites.

Detailed Summary

This phase II trial is studying how well umbilical cord blood transplant from a donor works in treating patients with hematological cancer. Giving chemotherapy and total-body irradiation (TBI) before a donor umbilical cord blood transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from an unrelated donor, that do not exactly match the patient's blood, 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 (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Aggressive Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Indolent Non-Hodgkin Lymphoma, Lymphoma, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Recurrent Chronic Lymphocytic Leukemia, Recurrent Follicular Lymphoma, Recurrent Lymphoplasmacytic Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, Refractory Follicular Lymphoma, Refractory Hodgkin Lymphoma, Refractory Lymphoplasmacytic Lymphoma, Refractory Mantle Cell Lymphoma, Refractory Small Lymphocytic Lymphoma, T-Cell Non-Hodgkin Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2008
Enrollment StartJun 25, 2008
Primary CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 17.9 years ago

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo umbilical cord blood transplant

Cyclophosphamidedrug

Given IV

Cyclosporinedrug

Given IV

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given IV or PO

Total-Body Irradiationradiation

Undergo TBI

Umbilical Cord Blood Transplantationprocedure

Undergo umbilical cord blood transplant