CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 260 enrolled / 260 target
Drug / intervention
busulfan +12 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/NCT00544115
NCT00544115Phase 2ActiveUpdate Overdue (0.9/mo)Completion was 231mo ago
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A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders

City of Hope Medical Center·interventional·Posted Oct 16, 2007·Updated Jun 2, 2026

In Brief

A Phase 2 clinical trial evaluating busulfan, cyclophosphamide, and 11 other interventions for Chronic Myeloproliferative Disorders and 7 related conditions. Active but no longer recruiting, targeting 260 participants.

Signals

Enrollment appears stalled

Detailed Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also 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 tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases, Precancerous/Nonmalignant Condition
Countries--
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2Active
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 16, 2007
Enrollment StartOct 16, 2001
Primary CompletionMar 13, 2007
Study CompletionMar 29, 2027
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 18.7 years ago

Arms & Interventions

Regimen Iactive_comparator

Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.

Drug: cyclophosphamideDrug: cyclosporineDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: total-body irradiation
Regimen IIactive_comparator

Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.

Drug: busulfanDrug: cyclophosphamideDrug: cyclosporineDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation
Regimen IIIactive_comparator

Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.

Drug: cyclosporineDrug: etoposideDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: total-body irradiation
Regimen IVactive_comparator

Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.

Drug: cyclosporineDrug: fludarabine phosphateDrug: melphalanDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation
Regimen Vactive_comparator

Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.

Drug: cyclosporineDrug: fludarabine phosphateDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: total-body irradiation
Regimen VIactive_comparator

Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.

Drug: busulfanDrug: cyclosporineDrug: fludarabine phosphateDrug: methotrexateDrug: mycophenolate mofetilDrug: sirolimusDrug: tacrolimusProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantation

Interventions

busulfandrug

cyclophosphamidedrug

cyclosporinedrug

etoposidedrug

fludarabine phosphatedrug

melphalandrug

methotrexatedrug

mycophenolate mofetildrug

sirolimusdrug

tacrolimusdrug

allogeneic hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure

total-body irradiationradiation