Study:
Phase II Study of Combination of Hyper-CVAD and Dasatinib With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (a BMT Study)
Rationale:
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).
Purpose:
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).
Study Status: Recruiting
Recruiting:
Anjali S. Advani 866-223-8100
| Condition |
Intervention |
Phase |
Adult Acute Lymphoblastic Leukemia in Remission
B-cell Adult Acute Lymphoblastic Leukemia
L1 Adult Acute Lymphoblastic Leukemia
L2 Adult Acute Lymphoblastic Leukemia
Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
T-cell Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia |
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: dexamethasone
Drug: dasatinib
Drug: cytarabine
Drug: methotrexate
Biological: filgrastim
Drug: methylprednisolone
Drug: leucovorin calcium
Drug: prednisone
Radiation: total-body irradiation
Drug: etoposide
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: sirolimus
Drug: tacrolimus
Other: laboratory biomarker analysis |
Phase 2 |
Verified by
National Cancer Institute (NCI)
April, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00792948
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Farhad Ravandi-Kashani., Principal Investigator