Phase II Trial of Pentostatin and Targeted Busulfan

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT00496340
Phase
PHASE2
Status
Completed

Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pentostatin — DRUG
    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.
  • Busulfan — DRUG
    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.
  • Rituximab — DRUG
    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.
  • Allogeneic Hematopoietic Cell Transplant — PROCEDURE
    Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.

Study Details

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.

Key Dates

Start date
Jul 31, 2007
Status verified
Mar 2014
Primary completion
Apr 30, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Conditioning Followed by HCT
    Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT). 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. Conditioning: 1. Patients will receive anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6. 2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4. 3. Patient will then receive pentostatin at a dose of 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3. 4. Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600. 5. Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan. 6. Rituximab: Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines.

Primary Outcome Measure

Incidence of Greater Than or Equal to 50% Donor Chimerism [ Time Frame: 28 days post-transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-

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