AALL1731: 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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Newly Diagnosed Standard Risk Or Down Syndrome B-lymphoblastic Leukemia (b-all) And The Treatment Of Patients With Localized B-lymphoblastic Lymphoma (b-lly)
  • Age: Between 1 - 31 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Eligibility Screening 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. 2) 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)

You may not be eligible for this study if the following are true:

  • 1) Exclusion Criteria Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Prior Therapy 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. For 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 >1,000/µL circulating leukemia cells. Patient must not have acute undifferentiated leukemia (AUL).


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