EUCTR2016-004877-42-ES进行中（未招募）1 期
A phase II, open-label study to evaluate the effect of blinatumomab administered during consolidation to reduce the level of minimal residual disease (MRD) assessed through flow cytometry in adult patients up to 55 years of age with high-risk Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukaemia (ALL) with good response (MRD < 0.1%) after induction therapy
FUNDACIÓN PETHEMA0 个研究点目标入组 38 人开始时间: 2018年2月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Men and women between 18 to 55 years of age, both inclusive.
- •2. 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:
- •o 11q23 abnormalities, or proven MLL rearrangement.
- •o Complex karyotype (more than 5 chromosome abnormalities).
- •- Pro-B ALL, regardless of the number of leukocytes.
- •3. 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.
- •4. ECOG < 2.
- •5. Ability to understand the study and willingness to sign the written informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. ALL with Philadelphia chromosome (Ph +).
- •2. Burkitt's leukemia (mature B phenotype) according to the WHO classification.
- •3. T cell ALL
- •4. ALL of precursors B with high risk characteristics with ER =0.1% (=1x10-3) after receiving
- •induction chemotherapy.
- •5. Previous history or presence of clinically significant disease of the central nervous system
- •(CNS): epilepsy, seizures, paresis, aphasia, stroke, brain injuries
- •severe, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome,
- •6. Presence or history of autoimmune disease with potential CNS involvement.
- •7. Radiotherapy in the 2 weeks prior to the start of treatment with blinatumomab.
- •8. Immunotherapy (eg, rituximab) in the 4 weeks prior to the start of treatment with
- •blinatumomab.
- •9. Any product under investigation for leukemia in the 4 weeks prior to the start of the
- •treatment with blinatumomab.
- •10. Treatment with any investigational medication after signing the consent
- •11. Candidate candidate for allogeneic transplantation of hematopoietic progenitors (TPH) in the
- •moment of inclusion.
- •12. Known hypersensitivity to immunoglobulins or to any component of the product in
- •investigation.
- •13. Abnormal laboratory values:
- •to. AST (SGOT) and / or ALT (SGPT) and / or alkaline phosphatase =5 ? LSN.
- •b. Total bilirubin =1.5 ? ULN (except if it is related to Gilbert's disease or
- •Meulengracht).
- •c. Creatinine =1.5 ? LSN.
- •d. Creatinine clearance calculated <50 ml / min.
- •and. Hemoglobin =9 g / dl (transfusion allowed).
- •14. History of malignant disease different from ALL in the 5 years prior to the start of treatment
- •with blinatumomab, with the exception of basal or squamous cell carcinoma of the skin or
- •carcinoma in situ of the cervix
- •15. Non-controlled active infection, or any other concurrent medical condition or disease that
- •it is considered that it interferes with the performance of the study according to the researcher's criteria.
- •16. HIV infection or chronic infection with hepatitis B virus (HBs Ag positive) or virus of the
- •Hepatitis C (anti-HCV positive).
- •17. Pregnant or lactating women.
- •18. Women of childbearing age who are not willing to use effective contraception during
- •Participation in the study and until at least 3 months later. Men who are not willing to
- •take measures to avoid pregnancy of the couple during participation in the study and
- •less until 3 months later.
- •19. Previous treatment with blinatumomab.
- •20. Patients who do not want or can not comply with the protocol.
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