EUCTR2006-005159-14-ES进行中（未招募）不适用
A Multi-Center, Multi-National, Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx, Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo, in Subjects with Hematologic Malignancies following Myeloablative TherapyEstudio de control de cohortes histórico, internacional y multicéntrico para la evaluación de la eficacia y seguridad del transplante de StemEx®, hemocitoblastos de cordón umbilical y células progenitoras expandidas ex vivo, en pacientes que padecen neoplasias hematológicas, a continuación del tratamiento mielosupresor - ExCell
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •a. Subject is a candidate for allogeneic myeloablative SCT for treatment of one of the following haematologic malignancies:
- •a.1 Clinical diagnosis of AML: CR2 or subsequent complete remission (CR) or CR1 with high-risk features including any of the following: stem cell or biphenotypic classification (AML-M0), erythroleukemia (AML-M6), acute megakaryocytic leukemia (AML-M7), high-risk cytogenetics, or failure to achieve CR after standard induction therapy or presentation with extramedullary disease or relapse with < 10% blasts in BM and no circulating blasts.
- •a.2 Clinical diagnosis of ALL: CR2 or subsequent CR or CR1 with high-risk features including: high-risk cytogenetics or with failure to achieve CR after standard induction therapy or elevated WBC at presentation (greater/equal 50,000 age <17 or greater/equal 20,000 age greater/equal 17) or presentation with extramedullary disease or relapse with < 10% blasts in BM and no circulating blasts.
- •a.3 Clinical diagnosis of CML: in CP1 (Chronic Phase 1) and resistant or intolerant to Gleevec or in CP2 or subsequent CP or in accelerated phase.
- •a.4 Clinical diagnosis of HD: induction failure or relapse and sensitive to last chemotherapy course.
- •a.5 Clinical diagnosis of NHL induction failure or relapse and sensitive to last chemotherapy course.
- •a.6 Clinical diagnosis of MDS with intermediate 2- or high-risk IPSS score.
- •b. Age 12 to 55.
- •c. Availability of CBU meeting requirements as laid down in protocol.
- •d. Subject's performance score greater or equal 70% by Karnofsky (age greater or equal 13) or a Lansky Play-Performance scale of greater or equal 70% (age above 13).
- •e. Subject has sufficient physiologic reserves as laid down in the protocol.
- •f. Subject must have either of the following back-up stem cell sources in case of engraftment failure:
- •f.1 Subject willing to undergo BM harvest or peripheral blood progenitor cell collection for use in case of engraftment failure.
- •f.2 Subject has a second CBU as a possible back up.
- •f.3 Subject's haploidentical family member has been identified and agreed to donate haematopoietic stem cells in case of engraftement failure.
- •g. Subject or guardian signs written informed consent.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a. Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except Hydroxyurea).
- •b. HIV positive.
- •c. Pregnancy or lactation.
- •d. Uncontrolled bacterial, fungal or viral infection.
- •e. Subjects with signs and symptoms of active central nervous system (CNS) disease.
- •f. Availability of appropriate related and willing stem cell donor, who is HLA-matched at 5 or 6/6 antigens.
- •g. Prior allogeneic cell transplant.
- •h. Allergy to bovine proteins or to aminoglyoside antibiotics (e.g. gentamicin) or to any product, which may interfere with the treatment.
- •i. Enrolled in another clinical trial or received an investigational treatment during the last 30 days, unless approved by Sponsor.
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