EUCTR2006-006520-19-DE进行中（未招募）不适用
An open-label, multicenter phase II study to investigate the efficacy, safety, and tolerability of the bi-specific T-cell engager (BITE) MT103 in patients with minimal residual disease (MRD) of positive B-precursor acute lymphoblastic leukemia (ALL) - MT103-202
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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. B–precursor ALL patients in complete hematological remission with molecular failure or molecular relapse starting at any time after consolidation I of front-line therapy within GMALL standards or at any time outside GMALL standards.
- •2. Patients must have a molecular marker for evaluation of minimal residual disease which is either:
- •- Bcr/abl at any detection level and/or t (4;11) translocation at any detection level messured by reverse transcription - polymerase chain reaction (RT-PCR)
- •- Individual rearrangements of immunoglobulin or TCR-genes measured by an assay with a sensitivity of minimum 10-4: At least one individual marker at a quantitative level equal or greater than 10-4.
- •3. ECOG Performance Status equal or smaller than 1.
- •4. Age equal or older than 18 years
- •5. Ability to understand and willingness to sign a written informed consent
- •6. Signed and dated written informed consent is available
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Current extra medullar involvement
- •2. History of or current relevant CNS pathology (except migraine/headache and/or previous infiltration of cerebro-spinal fluid (CSF) by ALL, age-related findings such as arteriosclerosis or findings induced by radiation or chemotherapy)
- •3. Current infiltration of cerebro-spinal fluid by ALL
- •4. History of or current autoimmune disease
- •5. Autologous stem cell transplantation within 6 weeks prior to study entry
- •6. Any prior allogeneic stem cell transplantation
- •7. Cancer chemotherapy within 4 weeks prior to study treatment (except for intrathecal prophylaxis and/or low dose maintenance therapy such as vincalkaloids, mercaptopurine, methotrexate, steroids)
- •8. Radiotherapy within 4 weeks prior to study treatment
- •9. Therapy with monoclonal antibodies (Rituximab, MabCampath) within 6 weeks prior to study treatment
- •10. Any investigational product within 4 weeks prior to study entry
- •11. Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation
- •12. Presence of human anti-murine antibodies (HAMA)
- •13. Abnormal bone marrow function as defined below:
- •- WBC < 3 000/mL
- •- Platelets < 50 000/mL
- •14. Abnormal renal or hepatic function as defined below:
- •- AST (SGOT) and/or ALT (SGPT) and/or AP equal or greater than 2 x upper limit of normal (ULN)
- •- GGT > 5 x ULN
- •- Total bilirubin equal or greater than 1.5 x ULN
- •- Creatinine clearance < 50 mL/min determined by the Cockroft-Gould formula.
- •15. Indication for a hypercoagulative state as defined below:
- •- D-Dimer equal or greater than 2,5 x ULN
- •- Antithrombin activity < 70%
- •16. Presenc of malignancy other than ALL
- •17. Active severe infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator
- •18. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive)
- •19. Pregnant or nursing women
- •20. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception dur-ing participation in the study and at least three months thereafter
研究者
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