Phase II Trial of Pentostatin and Targeted Busulfan

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

April 30, 2013

Study Completion Date

August 31, 2013

Conditions
Hematologic Malignancies
Interventions
DRUG

Pentostatin

"Pre-conditioning therapy:~All participants will receive pentostatin 4 mg/m\^2 on day -28. Patients may receive additional doses on days -21 \& -14 depending on cell counts.~Participant will receive pentostatin at a dose of 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3."

DRUG

Busulfan

"Pre-conditioning therapy:~Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4.~Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600."

DRUG

Rituximab

"Pre-conditioning therapy:~Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines."

PROCEDURE

Allogeneic Hematopoietic Cell Transplant

Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

All Listed Sponsors
lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER

NCT00496340 - Phase II Trial of Pentostatin and Targeted Busulfan | Biotech Hunter | Biotech Hunter