Cord Blood Expansion on Mesenchymal Stem Cells

PHASE1CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

July 3, 2007

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Myelodysplastic SyndromeLeukemia
Interventions
PROCEDURE

Cord Blood Infusion

Cord blood transplantation performed on day 0.

DRUG

Busulfan

32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).

DRUG

Fludarabine

"10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).~40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.~40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."

DRUG

Rituximab

375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.

OTHER

ATG

"1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.~1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3."

DRUG

Cyclophosphamide

50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.

DRUG

Clofarabine

30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).

RADIATION

Total Body Irradiation (TBI)

200 cGy at 25 cGy/minute delivered on Day -3.

DRUG

Melphalan

140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.

DRUG

Tacrolimus

0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.

DRUG

Mycophenolate Mofetil

1 gram by vein twice a day Days -3 through Day 100.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is \> 2.5 x 109/L.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

ViaCell

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT00498316 - Cord Blood Expansion on Mesenchymal Stem Cells | Biotech Hunter | Biotech Hunter