Cord Blood Expansion on Mesenchymal Stem Cells

Summary

The goal of this clinical research study is to learn if combining cord blood units will be safe and result in the cells "taking" faster in recipients. The cord blood units will have their cell number increased in the lab using cells from a family member or they will be collected from an unrelated healthy donor.

Conditions

• Myelodysplastic Syndrome
• Leukemia

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.

Sponsors & Collaborators

• ViaCell

  collaborator INDUSTRY

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Elizabeth Shpall, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-03

Primary Completion

2016-10-31

Completion

2016-10-31

Countries

• United States

Study Locations