Trial Search Results

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

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the 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 than 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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Asparaginase Erwinia chrysanthemi
  • Biological: Blinatumomab
  • Drug: Cyclophosphamide
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Doxorubicin Hydrochloride
  • Drug: Leucovorin Calcium
  • Drug: Mercaptopurine
  • Drug: Mercaptopurine Oral Suspension
  • Drug: Methotrexate
  • Drug: Pegaspargase
  • Drug: Prednisolone
  • Drug: Prednisone
  • Radiation: Radiation Therapy
  • Radiation: Radiation Therapy
  • Drug: Thioguanine
  • Drug: Vincristine Sulfate

Phase:

Phase 3

Eligibility


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 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.

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.

   - 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.

Ages Eligible for Study

365 Days - 31 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy Li
650-725-4318
Recruiting