CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Cyclosporine +6 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/NCT00796068
NCT00796068Phase 2Completed
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Transplantation of Umbilical Cord Blood in Patients With Hematological Malignancies Using a Treosulfan Based Preparative Regimen

Fred Hutchinson Cancer Center·interventional·Posted Nov 24, 2008·Updated Feb 17, 2023

In Brief

A Phase 2 clinical trial evaluating Cyclosporine, Fludarabine Phosphate, and 5 other interventions for Acute Biphenotypic Leukemia and 6 related conditions. Completed, enrolled 130 participants across 3 sites.

Detailed Summary

This phase II trial studies how well giving treosulfan together with fludarabine phosphate and total-body irradiation (TBI) works in treating patients with hematological cancer who are undergoing umbilical cord blood transplant (UCBT). Giving chemotherapy, such as treosulfan and fludarabine phosphate, and TBI before a donor UCBT helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or 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 also make an immune response against the body's normal cells. Giving cyclosporine (CsA) and mycophenolate mofetil (MMF) after the transplant may stop this from happening.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Myelodysplastic Syndrome (MDS)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartFeb 24, 2009
Primary CompletionDec 14, 2021
TodayJul 2, 2026
Enrollment to primary: 12.8 yearsPosted 17.6 years ago

Interventions

Cyclosporinedrug

Given IV or PO

Fludarabine Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Mycophenolate Mofetildrug

Given IV

Total-Body Irradiationradiation

TBI administered day -1: 200 cGy (or escalated to 300 cGy, 400 cGy, or 450 cGy per protocol statistical section)

Treosulfandrug

Given IV

Umbilical Cord Blood Transplantationprocedure

Undergo single or double unit UCBT