drugset / Trial / NCT00792948

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

NCT00792948

Phase 2 Active not recruiting 97 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops 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).

Timeline

Start
2009-09-01
Primary completion
2016-06-01
Completion
2027-01-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Cytarabine Small molecule Intravenous
Subject Dexamethasone Small molecule Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Etoposide Small molecule Intravenous
Subject Methotrexate Small molecule Intravenous
Subject Methylprednisolone Other / unclassified Intravenous
Subject Prednisone Other / unclassified Oral
Subject Vincristine Small molecule Intravenous
Subject dasatinib anhydrous Small molecule Oral
Background Leucovorin Small molecule Intravenous
Background Sirolimus Small molecule Oral
Background Tacrolimus Small molecule Intravenous
Background filgrastim Protein / enzyme biologic Subcutaneous