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Phase II Trial of Pentostatin and Targeted Busulfan

NCT00496340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-06-05

Study results available
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Summary

The objective of this trial is to determine whether a regimen of pentostatin and busulfan (IV) can facilitate engraftment of human leukocyte antigen (HLA) partially compatible siblings and unrelated donor transplants by using CD4+ laboratory-guided immunosuppression among 41 transplant patients meeting the inclusion criteria.

Conditions

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.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Marcie Riches, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2013-04-30
Completion
2013-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496340 on ClinicalTrials.gov