CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled / 30 target
Drug / intervention
busulfan +7 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/NCT00534430
NCT00534430Phase 2CompletedUpdate Overdue (0.1/mo)Completion was 194mo ago
CompareCT.gov

Phase II Study of IV Busulfan Combined With 12 cGy of Fractionated Total Body Irradiation (FTBI) and Etoposide (VP-16) as a Preparative Regimen for Allogeneic Bone Marrow Transplantation for Patients With Advanced Hematological Malignancies

City of Hope Medical Center·interventional·Posted Sep 24, 2007·Updated Jun 3, 2026

In Brief

A Phase 2 clinical trial evaluating busulfan, cyclosporine, and 6 other interventions for Leukemia and Myelodysplastic Syndromes. Completed, enrolled 30 participants.

Signals

Enrollment appears stalled

Detailed Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal 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 mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myelodysplastic Syndromes
Countries--
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartFeb 29, 2000
Primary CompletionApr 12, 2010
Study CompletionFeb 2, 2026
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 18.8 years ago

Arms & Interventions

Busulfan, FTBI and VP16experimental

IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant

Drug: busulfanDrug: cyclosporineDrug: etoposideDrug: mycophenolate mofetilProcedure: allogeneic bone marrow transplantationProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: total-body irradiation

Interventions

busulfandrug

cyclosporinedrug

etoposidedrug

mycophenolate mofetildrug

allogeneic bone marrow transplantationprocedure

allogeneic hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure

total-body irradiationradiation