Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (NCT00792948)

🧪 Interventions in This Study

• Cyclophosphamide (DRUG)
• Cytarabine (DRUG)
• Dasatinib (DRUG)
• Dexamethasone (DRUG)
• Doxorubicin Hydrochloride (DRUG)
• Etoposide (DRUG)
• Filgrastim (BIOLOGICAL)
• Leucovorin Calcium (DRUG)
• Methotrexate (DRUG)
• Methylprednisolone (DRUG)
• Prednisone (DRUG)
• Sirolimus (DRUG)
• Tacrolimus (DRUG)
• Vincristine Sulfate (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. INDUCTION/CONSOLIDATION REGISTRATION:
2. Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL), with evidence of ALL involvement in bone marrow and/or blood; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia are not eligible for this study; patients with L3 (Burkitts) are also not eligible
3. For ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell); NOTE: appropriate marker studies including cluster of differentiation (CD)19 (B cell), CD10, CD5, and CD7 (T cell) must be performed; co-expression of myeloid antigens (CD13 and CD33) will not exclude patients; if possible, the lineage specific markers cytoplasmic CD22 or CD79a (B cells), cytoplasmic CD3 (T cells) and cytoplasmic myeloperoxidase (MPO) (myeloid cells) must be determined
4. Patients may have received no more than one course of remission induction therapy for ALL; patients who have received any post-remission therapy for ALL or who have relapsed from complete remission are not eligible; (patients with previously untreated ALL can be eligible, and patients who have received one course of remission induction therapy for ALL can be eligible, regardless of their response to therapy); patients may have received no more than 14 days of tyrosine kinase inhibitor therapy prior to registration; any prior induction chemotherapy must have been completed no more than 28 days prior to registration
5. NOTE: If the patient has been initiated on the protocol defined regimen (i.e. the hyper-CVAD regimen without a tyrosine kinase inhibitor) before the Philadelphia chromosome (Ph)/BCR-ABL status was known, the patient may be registered on the protocol and start dasatinib; in this first course, dasatinib will be administered up to day 14 (i.e. if the patient is registered on day 5 and starts therapy on day 6, only 8 days of dasatinib will be administered and dasatinib will be completed on day 14)
6. For patients who have received any prior therapy that was NOT remission induction therapy, one of the following must be true:
7. At least 6 weeks must have elapsed since any monoclonal antibodies were given, at least 7 days must have elapsed since any other treatment was given, and all toxicities of the remission induction therapy must have resolved to grade =\< 2
8. The patient must have rapidly progressive disease (per institutional guidelines)
9. For previously treated patients, the study chair must be contacted before registration, in order to determine the regimen to be given in the first course of induction/consolidation therapy, based on prior therapy
10. Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive as confirmed by standard cytogenetics, fluorescent in situ hybridization (FISH), and/or polymerase chain reaction (PCR) testing performed by local laboratory; NOTE: samples will be submitted centrally for verification of results
11. Patients must have a bilirubin =\< 3.0 x institutional upper limit of normal (IULN) within 14 days prior to registration
12. Patients must have serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =\< 3.0 x IULN and/or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 3.0 x IULN within 14 days prior to registration; if both tests are done then both values must be =\< 3.0 x IULN

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (157 Sites)

Showing the first 25 of 157 sites.

• Banner University Medical Center - Tucson — Tucson, Arizona
• University of Arizona Cancer Center-North Campus — Tucson, Arizona
• City of Hope Comprehensive Cancer Center — Duarte, California
• Stanford Cancer Institute Palo Alto — Palo Alto, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• UF Health Cancer Institute - Gainesville — Gainesville, Florida
• AdventHealth Orlando — Orlando, Florida
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• MacNeal Hospital and Cancer Center — Berwyn, Illinois
• Hematology and Oncology Associates — Chicago, Illinois
• Northwestern University — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois
• Hematology Oncology Associates of Illinois-Highland Park — Highland Park, Illinois
• Presence Saint Mary's Hospital — Kankakee, Illinois
• AMG Libertyville - Oncology — Libertyville, Illinois
• Loyola University Medical Center — Maywood, Illinois
• DuPage Medical Group-Ogden — Naperville, Illinois
• Illinois Cancer Specialists-Niles — Niles, Illinois
• Hematology Oncology Associates of Illinois - Skokie — Skokie, Illinois
• Springfield Memorial Hospital — Springfield, Illinois
• Franciscan Saint Francis Health-Beech Grove — Beech Grove, Indiana
• Fort Wayne Medical Oncology and Hematology Inc-Parkview — Fort Wayne, Indiana
• Reid Health — Richmond, Indiana
• Siouxland Regional Cancer Center — Sioux City, Iowa
• Mercy Medical Center-Sioux City — Sioux City, Iowa

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Acute Lymphoblastic Leukemia

• Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia — Birmingham, Alabama
• Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia — Chicago, Illinois
• Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia — Birmingham, Alabama
• Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma — Charlotte, North Carolina
• European Prospective Investigation Into Childhood Cancer — New York, New York
• CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia — Bethesda, Maryland

Explore by condition: All Acute Lymphoblastic Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.