CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
busulfan +6 moredrug
Likely dose
busulfan 110 mg/m2from 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/NCT00782379
NCT00782379Phase 2Completed
CompareCT.gov

A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched Peripheral Blood Stem Cells for Patients With Hematologic Malignancies

Northside Hospital, Inc.·interventional·Posted Oct 31, 2008·Updated Nov 21, 2013

In Brief

A Phase 2 clinical trial evaluating busulfan, cyclophosphamide, and 5 other interventions for Leukemia and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma, Myelodysplastic Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.7 years ago

Interventions

busulfandrug

110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)

cyclophosphamidedrug

14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).

fludarabine phosphatedrug

30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)

mycophenolate mofetildrug

15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.

tacrolimusdrug

0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.

allogeneic hematopoietic stem cell transplantationprocedure

Patients to received unmanipulated PBSCs on Day 0

peripheral blood stem cell transplantationprocedure

patients to receive unmanipulated PBSCs on day 0