A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

Official record

Identifier

NCT03914625

Recruiting locations

countries

United StatesAustraliaCanadaNew ZealandPuerto Rico

Interventions studied

Asparaginase Erwinia chrysanthemiBlinatumomabCyclophosphamideCytarabineDexamethasoneDoxorubicin HydrochlorideLeucovorin CalciumMercaptopurineMercaptopurine Oral SuspensionMethotrexatePegaspargasePrednisolonePrednisoneRadiation TherapyRadiation TherapyThioguanineVincristine Sulfate

Lead sponsor

National Cancer Institute (NCI)

Target enrolment

6720 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Active, not recruiting

First posted

Apr 16, 2019

Last updated on the registry

Oct 1, 2026

Age

365 Days – 31 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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 Criteria:

* 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.

Indexed under

Leukemia