At a glance
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Phase II Trial of Pentostatin and Targeted Busulfan as a Novel Reduced Intensity Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Using Laboratory-Guided (CD4-guided) Immunosuppression.
In Brief
A Phase 2 clinical trial evaluating Pentostatin, Busulfan, and 2 other interventions for Hematologic Malignancies. Completed, enrolled 42 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.
Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.