CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Anti-Thymocyte Globulin +11 morebiological
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/NCT03096782
NCT03096782Phase 2Completed
CompareCT.gov

Cord Blood Ex-Vivo MSC Expansion Plus Fucosylation to Enhance Homing and Engraftment

M.D. Anderson Cancer Center·interventional·Posted Mar 30, 2017·Updated Oct 11, 2023

In Brief

A Phase 2 clinical trial evaluating Anti-Thymocyte Globulin, Busulfan, and 10 other interventions for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive and 21 related conditions. Completed, enrolled 6 participants across 1 site.

Detailed Summary

This phase II trial studies how well an umbilical cord blood transplant with added sugar works with chemotherapy and radiation therapy in treating patients with leukemia or lymphoma. Giving chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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. The umbilical cord blood cells will be grown ("expanded") on a special layer of cells collected from the bone marrow of healthy volunteers in a laboratory. A type of sugar will also be added to the cells in the laboratory that may help the transplant to "take" faster.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAccelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Acute Biphenotypic Leukemia, Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Chemotherapy-Related Leukemia, Chronic Lymphocytic Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Langerhans Cell Histiocytosis, Minimal Residual Disease, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts, Non-Hodgkin Lymphoma, Recurrent Hodgkin Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Myelodysplastic Syndrome, Small Lymphocytic Lymphoma, Therapy-Related Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 30, 2017
Enrollment StartOct 13, 2017
Primary CompletionSep 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.3 years ago

Interventions

Anti-Thymocyte Globulinbiological

Given IV

Busulfandrug

Given IV

Clofarabinedrug

Given IV

Cyclophosphamidedrug

Given IV

Filgrastim-sndzbiological

Given SC

Fludarabinedrug

Given IV

Melphalandrug

Given IV

Mycophenolate Mofetildrug

Given IV or PO

Rituximabbiological

Given IV

Tacrolimusdrug

Given IV

Total-Body Irradiationradiation

Undergo total body irradiation

Umbilical Cord Blood Transplantationprocedure

Undergo cord blood transplant