Total Marrow Irradiation for Refractory Acute Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

November 30, 2016

Study Completion Date

December 31, 2016

Conditions
Acute Lymphoblastic LeukemiaMyelodysplastic SyndromeMultiple Myeloma
Interventions
DRUG

cyclophosphamide

60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg

DRUG

cyclosporine

Beginning on Day -3 pre-transplant maintaining a level of \>200 ng/mL. CSA dosing will be monitored and altered as clinically appropriate by Pharm D or physician, and discontinue at approximately day + 180 post-transplant.

DRUG

Fludarabine

25 mg/m2/day intravenous as a 1 hour infusion for consecutive 3 days pre-transplant, total dose 75 mg/m2

DRUG

mycophenolate mofetil

Beginning on day -3, use intravenous route between days -3 and +5, followed by oral administration on Day +6 through +30, if tolerated. 15mg/kg/dose for patients \<40 kg, 3 gm/day for patients \>40 kg.

RADIATION

total marrow irradiation

Dose escalating schedule per Cohort (TMI: 300 cGy) once daily.

PROCEDURE

umbilical cord blood transplantation

product will be infused via intravenous drip on Day 0 according to current University of Minnesota guidelines for Umbilical Cord Blood Grafts

BIOLOGICAL

Granulocyte colony-stimulating factor

5 mcg/kg/day intravenous or subcutaneous based on body weight beginning on Day +1 after umbilical cord blood infusion until absolute neutrophil count exceeds 2.5 x 10\^9/L for 3 consecutive days.

BIOLOGICAL

HLA-matched related donor bone marrow

Related donor bone marrow or mobilized stem cells will be collected (target cell dose 5x10\^8 nucleated cells/kg recipient weight, minimum 3x10\^8 nucleated cells/kg recipient weight) and infused without processing on day 0 according to University of Minnesota Blood and Marrow Transplant Program guidelines.

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00686556 - Total Marrow Irradiation for Refractory Acute Leukemia | Biotech Hunter | Biotech Hunter