CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 76 enrolled
Drug / intervention
Pentostatin +4 moredrug
Likely dose
Pentostatin 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00571662
NCT00571662Phase 2Completed
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Allogeneic Peripheral Blood Stem Cell Transplantation With Minimally Myelosuppressive Regimen of Pentostatin and Low-dose Total-body Irradiation

University of Nebraska·interventional·Posted Dec 12, 2007·Updated Oct 24, 2023

In Brief

A Phase 2 clinical trial evaluating Pentostatin, Total-body irradiation (TBI), and 3 other interventions for Acute Myelogenous Leukemia and 8 related conditions. Completed, enrolled 76 participants across 1 site.

Detailed Summary

This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndromes, Multiple Myeloma, Non-Hodgkins Lymphoma, Hodgkins Disease, Peripheral T-cell Lymphoma
CountriesUnited States
CollaboratorsAstex Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 12, 2007
Enrollment StartDec 8, 2000
Primary CompletionDec 30, 2008
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 18.6 years ago

Interventions

Pentostatindrug

4 mg/m\^2 intravenous(IV)once a day(QD)x3days (days -10, -9, -8)

Total-body irradiation (TBI)radiation

TBI will consist of 2.0 GY at 8-12cGy/min via 6MV photons delivered AP/PA fields, without lung blocks or via lateral fields with lucite compensator along the head and neck region. TLD (thermal luminescent dosimetry) will be used to verify dose uniformity. TBI will be given on day -1.

Cyclosporine A (CsA)drug

CsA will be given at 2.0 mg/kg intravenous (IV) Q 12hrs on days -1,0,and+1 (total 6 doses) then converted to oral at 2 mg/kg by mouth (PO) twice a day (BID) until day+80, then tapered 10% per week over approximately 3 months if no GVHD for related donor transplants. For unrelated CsA will be given at same dose and schedule until day+100 then tapered by 10% per week if no GVHD

Mycophenolate Mofetil (MMF)drug

MMF 15 mg/kg by mouth twice a day (PO BID) will be given from day 0-27 then stopped without tapering for related donor transplants. For unrelated donor transplants MMF will be given at same dose until day+40 then tapered over 2months. in absence of GVHD. Doses will be rounded to nearest 250 mg.

G-CSFdrug

10 mcg/kg/day subcutaneously for at least 4 consecutive days.