CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Cyclophosphamide +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/NCT00719888
NCT00719888Phase 2Completed

Transplantation of Umbilical Cord Blood for Patients With Hematological Diseases With Cyclophosphamide/Fludarabine/Total Body Irradiation or Cyclophosphamide/Fludarabine/Thiotepa/Total Body Irradiation Myeloablative Preparative Regimen

Fred Hutchinson Cancer Center·interventional·Posted Jul 22, 2008·Updated Mar 7, 2025

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Cyclosporine, and 7 other interventions for Acute Biphenotypic Leukemia and 18 related conditions. Completed, enrolled 135 participants across 3 sites.

Detailed Summary

This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic disease. Giving chemotherapy, such as cyclophosphamide and fludarabine, and 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 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. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2008
Enrollment StartNov 18, 2005
Primary CompletionDec 22, 2023
Study CompletionDec 19, 2024
TodayJul 2, 2026
Enrollment to primary: 18.1 yearsPosted 17.9 years ago

Interventions

Cyclophosphamidedrug

Given IV

Cyclosporinedrug

Given IV and PO

Double-Unit Umbilical Cord Blood Transplantationprocedure

Undergo double-unit UCBT

Fludarabinedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given IV and PO

Total-Body Irradiationradiation

Undergo high-dose or moderate-intensity TBI

Umbilical Cord Blood Transplantationprocedure

Undergo UCBT

Thiotepadrug

Given IV