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RecruitingLast updated: 5 February 2024

AALL1731: This Phase III trial is evaluating how well targeted therapy (blinatumomab) works in combination with chemotherapy in treating people with newly diagnosed, standard risk B-lymphoblastic leukaemia or 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 summary

Summary

This is a randomised, open-label trial with multiple active comparator and experimental arms investigating Blinatumomab in combination with chemotherapy in patients with newly diagnosed standard risk or Down Syndrome B-Lymphoblastic Leukaemia (B-ALL) and the treatment of patients with localised B-Lymphoblastic Lymphoma (B-LLy). The trial is seeking to determine whether the addition of 2 cycles of blinatumomab to standard therapy improves disease-free survival.

Conditions

This trial is treating patients with B Acute Lymphoblastic Leukaemia B Lymphoblastic Lymphoma

Cancer

Blood Cancers Haematological

Age

People1 - 31

Phase

III

Trial Acronym

AALL1731

More information

Trial Identifiers

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Trial sponsor

National Cancer Institute (NCI)

Scientific Title

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)

Eligibility

Inclusion

  • 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.
  • 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 patient has 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 patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

Exclusion

  • Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine.
  • 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.
  • Patients who have received > 72 hours of hydroxyurea within 1 week (7 days) prior to the start of systemic protocol therapy.
  • B-ALL patients 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/uL circulating leukemia cells.
  • Patient must not have acute undifferentiated leukemia (AUL).
  • Non-DS B-ALL patients with central nervous system [CNS]3 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 (> 25% blasts) marrow.
  • Patients with known Charcot-Marie-Tooth disease.
  • Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype.
  • Patients requiring radiation at diagnosis.
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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