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Protocol No. E1910

Principal Investigator Mattison, Ryan

Phase III

Age Group Adult

Scope National

Sponsor Type National

Title A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL Negative B Lineage Acute Lymphoblastic Leukemia in Adults

Objective The purpose of this study is to determine what affects (good and bad) the therapy blinatumomab has on your type of cancer (BCR/ABL negative ALL). This new therapy will be added to what has traditionally been used to treat your specific sub-type of ALL. Studies are being done in ALL and other blood cancers with blinotumomab. It is hoped that blinatumomab will target your B-cell ALL and destroy these specific cells, but it has not yet been proven.

Treatment There are several steps of treatment in this study. They are called induction, intensification, consolidation, and maintenance. In these study steps you will be getting standard chemotherapy treatments that may or may not be combined with an investigational cancer drug called blinatumomab. Your doctor may recommend you to have a blood or marrow transplant (BMT) at a later date after randomization to the blinatumomab/no blinatumomab arms, if you have a suitable donor.

Description In the first part of this study (induction chemotherapy) you will receive multiple chemotherapy drugs by injection into a vein or into a muscle. Induction treatment will take up to 3 months. To prevent the leukemia from appearing around the spinal cord later you will also receive injections of chemotherapy into the spinal canal in your lower back or through a reservoir placed under the skin in your head. These chemotherapy drugs are given at various time points and include daunorubicin by vein, vincristine by vein, pegaspargase by vein or into the muscle, dexamethasone by mouth, cytarabine by vein and into the spinal canal, methotrexate into the spinal canal, cyclophosphamide into a vein, and 6- mercaptopurine by mouth. If you have achieved a remission, your treatment on this study will continue to Intensification treatment. This part of the treatment is to treat residual leukemia cells in your bone marrow and blood that are not easily seen and also helps prevent the leukemia from appearing in your spinal fluid. After the study treatment step called ‘intensification”, you will be "randomized" into one of the study groups. If you are randomized to the blinatumomab group, you will initially receive two cycles of blinatumomab. Blinatumomab is given as a continuous intravenous infusion. It is recommended that you be hospitalized for at least the first 3 days of blinatumomab treatment with the first cycle and for at least two days for the second cycle. If you are randomized to the “No blinatumomab” group, you may proceed directly to a blood or marrow transplant if you have a suitable donor, or you may proceed directly to consolidation chemotherapy. Click here for more info

Key Eligibility
  • Age ≥ 30 years and ≤ 70 years
  • New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping. Cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible
  • Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, FISH and/or PCR. Patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations
  • Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood
  • Patient must not have a concurrent active malignancy for which they are receiving treatment
  • Patient should be HLA typed (A, B, C, DR and DQ) during induction therapy phase
  • Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia
  • Patient must not have a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalities
  • Women must not be pregnant or breast-feeding

Applicable Disease Sites Leukemia

Therapies Involved Bone Marrow Transplant; Cytotoxic Chemotherapy

Drugs Involved 6-mercaptopurine; 6-mp (6-mercaptopurine); Blinatumomab; Oncaspar (pegasparaginase); ara-c (cytarabine); cerubidine (daunorubicin); cpm (cyclophosphamide); ctx (cyclophosphamide); cyclophosphamide; cytarabine; cytosar (cytarabine); cytosine arabinoside (cytarabine); cytoxan (cyclophosphamide); daunomycin (daunorubicin); daunorubicin; decadron (dexamethasone); dexamethasone; dnm (daunorubicin); etoposide; hdmtx (methotrexate); it-mtx (methotrexate); leucovorin; leukovorin (leucovorin); lv (leucovorin); methotrexate; mtx (methotrexate); neosar (cyclophosphamide); oncovin (vincristine); peg-asparaginase (pegasparaginase); pegasparaginase; prednisone; rubidamycin (daunorubicin); vcr (vincristine); vepesid (etoposide); vin (vincristine); vincristine; vp-16 (etoposide); wellcovorin (leucovorin)

Status Open

Participating Institutions UW Hospital and Clinics