Phase I/II Study of Pentostatin Combined With Tacrolimus and Mini-Methotrexate for GVHD Prevention After MUD BMT

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 30, 2000

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
LeukemiaLymphoma
Interventions
DRUG

Pentostatin

"Given intravenously on days +8, +15, +22 and +30 post transplant:~Group 2 - Pentostatin 0.5 mg/m\^2~Group 3 - Pentostatin 1 mg/m\^2~Group 4 - Pentostatin 1.5 mg/m\^2~Group 5 - Pentostatin 2 mg/m\^2"

DRUG

Tacrolimus

Given intravenously from day -2, and will be switched to oral dosing when tolerated.

DRUG

Methotrexate

Given intravenously on days +1, +3, and +6 at the dose of 5 mg/m2.

Trial Locations (1)

77030

U.T.M.D. Anderson Cancer Center, Houston

Sponsors
All Listed Sponsors
collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER