EUCTR2012-005580-27-IT进行中（未招募）1 期
MULTI-CENTER, PHASE II STUDY TO ASSESS THE SAFETY AND EFFICACY OF HAPLOIDENTICAL BONE MARROW TRANSPLANTATION USING REDUCED INTENSITY CONDITIONING (RIC) REGIMEN AND POST-TRANSPLANT CYCLOPHOSPHAMIDE, IN PATIENTS WITH POOR PROGNOSIS LYMPHOMAS.
ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 47 人开始时间: 2013年2月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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
- •PATIENT-RELATED CRITERIA
- •1. Age 18-70 years old
- •2. Karnofsky performance score = 80%
- •3. HLA typing will be performed at high resolution (allele level) for the HLA-A, -B, Cw, DRB1, and DQB1 loci. A minimum match of 5/10 is required. An unrelated donor search is not required for a patient to be eligible for this protocol if the clinical situation dictates an urgent transplant.
- •4. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1
- •5. Patients with lymphomas (any histology) relapsed after high dose chemotherapy and in complete remission or partial remission after the last CT line.
- •a. Hodgkin’s lymphoma.
- •Patients refractory to at least 2 CT lines, and included in tandem auto-allo program.
- •b. Diffuse large B cell lymphoma
- •Refractory to second line salvage chemotherapy (patients in partial remission, stable disease or progressive). These patients have to be in partial remission or complete remission after last CT line, including high dose chemotherapy (auto-allo program).
- •Transformed low grade lymphomas
- •c. Peripheral T cell lymphoma
- •Patients failing to achieve a complete remission after first line CT.
- •d. Low grade lymphomas (follicular and non follicular)
- •Patients refractory to first R-CT line.
- •Patients failing at least 2 lines CT - The duration of last remission should be < 1 year
- •e. Chronic lymphatic leukemia.
- •Patients with refractory or relapsing (response duration < 1 year) disease after R-Fludarabine CT
- •f. Mantle cell lymphoma.
- •Patients relapsing or refractory after first line conventional CT.
- •6. Absence of HLA identical sibling and 10/10 unrelated donor
- •7. Patients with adequate physical function as measured by:
- •? Hearth FEV fraction = 40%;
- •? Total bilirubin = 2.5 mg/dl, ALT, AST, and alkaline phosphatase all = 5 x upper limit of normal (ULN);
- •? Creatinine clearance or GFR by Cockroft-Gault formula = 50 mL/min/1.73m2;
- •? FEV1,FVC, DLCO = 50% predicted
- •DONOR SELECTION CRITERIA
- •1. Donors must be HLA-haploidentical first-degree relatives of the patient. Eligible donors include biological parents, siblings, or children, or half-siblings.
- •2. Age = 18 years.
- •3. Donors must meet the selection criteria as defined by JACIE
- •4. Absence of DSA (donor specific antibody against HLA antigens)
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Presence of HLA-matched, related donor (HLA-A, -B, -DRB1)
- •2. Presence of matched unrelated donor (10/10), available on time.
- •3. Pregnancy or breast-feeding.
- •4. Evidence of HIV infection or known HIV positive serology.
- •5. Current uncontrolled bacterial, viral or fungal infection
- •6. Evidence of progression of clinical symptoms or radiologic findings.
- •7. Prior allogeneic hematopoietic stem cell transplant.
- •8. CNS lymphoma localization
研究者
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