Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (NCT04530565)

🧪 Interventions in This Study

• Blinatumomab (BIOLOGICAL)
• Cyclophosphamide (DRUG)
• Cytarabine (DRUG)
• Dasatinib (DRUG)
• Dexamethasone (DRUG)
• Doxorubicin Hydrochloride (DRUG)
• Mesna (DRUG)
• Methotrexate (DRUG)
• Ponatinib Hydrochloride (DRUG)
• Prednisone (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. ELIGIBILITY CRITERIA FOR PRE-REGISTRATION (TO STEP 0)
2. Patient must be \>= 18 and =\< 75 years of age
3. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-3
4. Patient must be newly diagnosed with B acute lymphoblastic leukemia (B-ALL) or is suspected to have acute lymphoblastic leukemia (ALL)
5. Patient must have BCR-ABL1 positive disease. The diagnosis of ALL and the presence of BCR-ABL translocation must be confirmed centrally. Patients can be registered and begin step 1 therapy while awaiting central laboratory eligibility confirmation
6. NOTE: Bone marrow aspirate and/or peripheral blood specimen must be submitted to the ECOG-American College of Radiology Imaging Network (ACRIN) Leukemia Laboratory at MD Anderson Cancer Center to determine patient's eligibility for registration to Step 1 or confirm patient evaluability. Centrally fluorescence-activated cell sorting (FACS) analysis will be performed to determine B-ALL and to exclude acute myeloid leukemia (AML) or acute bi-phenotypic leukemia and baseline BCR-ABL status will be determined by fluorescent in situ hybridization (FISH). The ECOG-ACRIN Leukemia Laboratory will forward results within 48 hours of receipt of the specimen to the submitting institution. Bone marrow aspirate is to be from first pull (initial or re-direct). Specimens must contain sufficient blast cells. In cases where the bone marrow aspiration may be inadequate, or the bone marrow examination has already been performed prior to study consent and enrollment on Step 0, peripheral blood may be submitted, with recommendation that adequate circulating blasts are present (\> 10%). If a diagnosis of BCR-ABL positive B-ALL has already been established by local Clinical Laboratory Improvement Act (CLIA) certified laboratories, the patient may be registered to step 1 without waiting for central confirmation
7. Patient must not have a diagnosis of BCR/ABL T-ALL
8. Patient must not have received chemotherapy for B-ALL. Patients who received up to five days of therapy (hydroxyurea and/or steroids of any kind) with the aim to reduce disease burden prior to study registration to Step 1 are eligible
9. Patient must not have unstable epilepsy that requires treatment
10. Patients with lymphoid blast crisis chronic myeloid leukemia (CML) are not eligible
11. ELIGIBILITY CRITERIA FOR REGISTRATION TO STEP 1
12. Patient must have a diagnosis of Philadelphia chromosome positive (Ph+) ALL that has been determined locally and bone marrow and/or peripheral blood was sent and receipt confirmed for central confirmation or determined centrally by the ECOG-ACRIN Leukemia Laboratory at MD Anderson Cancer Center

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

📍 All Participating Trial Locations (211 Sites)

Showing the first 25 of 211 sites.

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Community Cancer Institute — Clovis, California
• University Oncology Associates — Clovis, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California
• UC San Diego Moores Cancer Center — La Jolla, California
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
• Yale University — New Haven, Connecticut
• Augusta University Medical Center — Augusta, Georgia
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii
• Queen's Cancer Cenrer - POB I — Honolulu, Hawaii
• Queen's Medical Center — Honolulu, Hawaii
• Straub Clinic and Hospital — Honolulu, Hawaii
• University of Hawaii Cancer Center — Honolulu, Hawaii
• Hawaii Cancer Care Inc-Liliha — Honolulu, Hawaii

💰 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 B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1

• Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia — Houston, Texas
• Asciminib as Maintenance Treatment After Cellular Therapies for Adults With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia — Duarte, California
• Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma — Seattle, Washington

Explore by condition: All B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 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.