Blinatumomab in Combination With Chemotherapy in Treating Patients With or Without Down Syndrome and Newly Diagnosed, Standard Risk B-Lymphoblastic Leukemia or Localized B-Lymphoblastic Lymphoma
A Phase 3 Trial Investigating Blinatumomab ( NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphoma (B-LLy)
Clinical Trial Information
Trial Contact: El-Shami, Jessica; Leffin, Melissa; Spinelli, Jennifer; Cevallos, Claudia
IRB No: AALL1731
Protocol Abbrev: AALL1731
Principal Investigator: Amy A Smith, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: AALL1731
Treatment: Drug: Asparaginase Erwinia chrysanthemi Biological: Blinatumomab Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone Drug: Doxorubicin Drug: Leucovorin Drug: Mercaptopurine Drug: Methotrexate Drug: Prednisolone Drug: Prednisone Drug: Thioguanine Drug: Vincristine
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT03914625
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with or without Down syndrome and newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.
• All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 and MUST submit eligibility studies.
• Age at diagnosis:
◦Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).
◦Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).
◦Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS).
• B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment).
• B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment).
• Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate;
◦OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy;
◦OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells;
◦OR newly diagnosed B-cell LLy Murphy stages I or II, with or without Down syndrome.
◦Note: For B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL. For tissue processed by other means (i.e., paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted (diagnostic biopsy for B-LLy must be performed within 14 days prior to enrollment).
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
• All patients and/or their parents or legal guardians must sign a written informed consent.