CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
cyclophosphamide +9 moredrug
Likely dose
Not stated in 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/NCT00445744
NCT00445744N/ACompleted
CompareCT.gov

Cyclophosphamide Followed by Intravenous Busulfan as Conditioning for Hematopoietic Cell Transplantation in Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome.

Fred Hutchinson Cancer Center·interventional·Posted Mar 9, 2007·Updated Jan 2, 2018

In Brief

A clinical study evaluating cyclophosphamide, busulfan, and 8 other interventions for Adult Acute Myeloid Leukemia in Remission and 21 related conditions. Completed, enrolled 52 participants across 1 site.

Detailed Summary

This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stops the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Childhood Acute Myeloid Leukemia in Remission, Childhood Myelodysplastic Syndromes, de Novo Myelodysplastic Syndromes, Essential Thrombocythemia, Myelodysplastic Syndrome With Isolated Del(5q), Polycythemia Vera, Previously Treated Myelodysplastic Syndromes, Primary Myelofibrosis, Recurrent Adult Acute Myeloid Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Secondary Myelofibrosis, Untreated Adult Acute Myeloid Leukemia, Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI)

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 9, 2007
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2011
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 19.3 years ago

Interventions

cyclophosphamidedrug

Given IV

busulfandrug

Given IV

tacrolimusdrug

Given IV or PO

methotrexatedrug

Given IV

cytogenetic analysisgenetic

Correlative studies

flow cytometryother

Correlative studies

pharmacological studyother

Correlative studies

pharmacogenomic studiesother

Correlative studies

peripheral blood stem cell transplantationprocedure

Undergo PBPC transplantation

allogeneic hematopoietic stem cell transplantationprocedure

Undergo allogeneic transplantation