Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

July 13, 2012

Primary Completion Date

April 25, 2017

Study Completion Date

April 25, 2017

Conditions
Blood And Marrow TransplantationLeukemiaLymphomaTransplantation InfectionTransplantation, Bone Marrow
Interventions
DRUG

Melphalan

140 mg/m2 by vein on Day -2 only for Fludarabine + Melphalan group.

DRUG

Fludarabine

10 mg/m2 by vein on Days -7 to -4 for Melphalan + Thiotepa + Fludarabine group, or 40 mg on Days -5 to -2 for Fludarabine + Melphalan group.

DRUG

Mycophenolate mofetil

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth twice a day from Days -3 to +100 in the absence of Graft vs Host Disease (GvHD).

DRUG

Tacrolimus

Starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no Graft vs Host Disease (GvHD) is present.

PROCEDURE

Cord Blood Infusion

Cord blood infusion on Day 0. Each participant will receive cells from one unexpanded cord blood sample plus cells from a second cord blood sample that has undergone fucosylation.

DRUG

Rituximab

375 mg/m\^2 by vein on Day -10 for B cell malignancy.

DRUG

ATG

"1.25 mg/Kg by vein on Day -4.~1.75 mg/Kg by vein on Day -3."

DRUG

Busulfan

Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9. Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 subsequently adjusted to target an AUC of 4,000 microMol.min-1.

DRUG

Clofarabine

30 mg/m\^2 IV Day -7 to Day -4;

RADIATION

Total Body Irradiation (TBI)

2 Gy in AM of Day -3.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

American Stem Cell, Inc.

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT01471067 - Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies | Biotech Hunter | Biotech Hunter