PETHEMA-BLIN-01/PET069014 (BLIN-01)

Launched by PETHEMA FOUNDATION · May 1, 2018

Keywords

ClinConnect Summary

In the pre-phase, patients receive treatment according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), with: Prednisone (PDN) 60 mg/m2, PO or IV until complete characterisation of the ALL, for a maximum of 7 days, Triple intrathecal therapy, Methotrexate (MTX) 12 mg, ARA-C: 30 mg, Hydrocortisone 20 mg.

Standard induction chemotherapy that these patients receive according to routine clinical practice at Spanish sites, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), consis...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women between 18 to 55 years of age, both inclusive.
• • Patients with Philadelphia chromosome-negative or BCR-ABL-negative, CD19-positive ALL, with high-risk characteristics. The definition of high-risk ALL implies the presence of one or more of the following factors: Aged 30-55 years; Leukocytes \> 30×109/l in B-precursor ALL; Any of the following cytogenetic or molecular abnormalities: 11q23 abnormalities, or proven MLL rearrangement; Complex karyotype (more than 5 chromosome abnormalities); Pro-B ALL, regardless of the number of leukocytes.
• • Previous treatment according to routine clinical practice in Spanish centres, in accordance with the PETHEMA protocol for patients with high-risk ALL (ALL-AR-11), in complete remission (MRD \< 0.1%) (\< 1×10-3) centralised assessment through flow cytometry) after induction therapy.
• • ECOG \< 2.
• • Ability to understand the study and willingness to sign the written informed consent form
• Exclusion Criteria:
• • Philadelphia chromosome-positive (Ph+) ALL.
• • Burkitt's leukaemia (mature B phenotype) according to the WHO classification.
• • T-cell ALL.
• • B-precursor ALL with high-risk characteristics and MRD ≥ 0.1% (≥ 1×10-3) after receiving induction chemotherapy.
• • Previous history or presence of a clinically significant disease of the central nervous system (CNS): epilepsy, seizures, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis.
• • Presence or history of an autoimmune disease potentially affecting the CNS.
• • Radiotherapy in the 2 weeks prior to starting treatment with blinatumomab.
• • Immunotherapy (e.g., rituximab) within 4 weeks prior to starting treatment with blinatumomab.
• • Any investigational product for leukaemia in the 4 weeks prior to starting treatment with blinatumomab.
• • Treatment with any investigational medicinal product after signing the informed consent form.
• • Candidate patient for allogeneic haematopoietic stem cell transplantation (HSCT) at the time of enrolment.
• • Known hypersensitivity to human immunoglobulins or to any component of the investigational product.
• • Abnormal laboratory values: AST (SGOT) and/or ALT (SGPT) and/or alkaline phosphatase ≥ 5 ULN;total bilirubin ≥ 1.5 ULN (unless related to Gilbert's syndrome or Meulengracht's disease); Creatinine ≥ 1.5 ULN; Estimated creatinine clearance \< 50 ml/min; Haemoglobin ≥ 9 g/dl (transfusion permitted).
• • History of malignant disease other than ALL in the 5 years prior to starting treatment with blinatumomab, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• • Active uncontrolled infection, or any other concurrent disease or medical condition considered to interfere with the conduct of the study as per the investigator's discretion.
• • HIV infection or chronic hepatitis B virus (HBsAg positive) or hepatitis C virus infection (anti-HCV positive).
• • Pregnant or breast-feeding women.
• • Women of childbearing potential who are not willing use an effective method of contraception during their participation in the study and for at least 3 months thereafter. Men who are not willing to take measures to prevent their partner from becoming pregnant during their participation in the study and for at least 3 months thereafter.
• • Prior treatment with blinatumomab.
• • Patients who do not want or are unable to meet the protocol requirements