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Protocol No. AALL1731

Principal Investigator DeSantes, Kenneth

Phase III

Age Group Both

Scope National

Sponsor Type National

Title A Phase 3 Trial Investigating Blinatumomab (IND# 117467, 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)

Treatment Contact study coordinator

Description A Phase 3 Trial Investigating Blinatumomab (IND# 117467, 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)

Key Eligibility
  • All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to treatment and enrollment on AALL1731
  • Must be greater than or equal to 365 days and less than 10 years of age (B-ALL patients without DS)
  • Must be greater than or equal to 365 days and less than or equal to 31 years of age (B-ALL patients with DS)
  • Must be greater than or equal to 365 days and less than or equal to 31 years of age (B-LLy patients with or without DS)
  • B-ALL patients without DS must have an initial white blood cell count B-ALL patients with DS are eligible regardless of the presenting WBC
  • Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a 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/μL circulating leukemic cells; OR Patient has newly diagnosed B-cell LLy Murphy Stages I or II with or without Down syndrome
    EXCLUSION
  • Must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
  • With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731
  • Patients receiving steroid pretreatment, the following additional exclusion criteria apply: Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids, DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis
  • B-ALL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing greater than 1,000/μL circulating leukemia cells
  • Patient must not have acute undifferentiated leukemia (AUL)
  • Non-DS B-ALL patients with CNS3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment
  • Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular disease are eligible but will be assigned to the DS-High B-ALL arm)
  • For LLy patients, the following additional exclusion criteria apply: T-Lymphoblastic Lymphoma, Morphologically unclassifiable lymphoma, Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma, CNS positive disease or testicular involvement, M2 (5%-25% blasts) or M3 (greater than 25% blasts) marrow
  • Can not be pregnant or breastfeeding
  • Male and Female of childbearing potential must agree to adequate birth control as defined by the protocol

  • Applicable Disease Sites Leukemia; Lymphoma

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics