Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning

PHASE2CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

April 11, 2012

Primary Completion Date

August 11, 2022

Study Completion Date

August 11, 2022

Conditions
LeukemiaAcute Myeloid LeukemiaAcute Lymphocytic LeukemiaChronic Myeloid LeukemiaChronic Lymphocytic LeukemiaMyeloproliferative DiseasesNon-Hodgkins LymphomaHodgkins LymphomaMultiple MyelomaMyelodysplastic Syndrome
Interventions
DRUG

Fludarabine monophosphate

40 mg/m2 by vein on Days -6 through -3.

DRUG

Busulfan

First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.

PROCEDURE

Stem Cell Infusion

Fresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0.

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.

DRUG

Methotrexate

5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 \* 10/L for 3 consecutive days.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT01572662 - Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning | Biotech Hunter | Biotech Hunter