NL-OMON32010已完成2 期
Allogeneic hematopoietic cell transplantation with HLA-matched donors : a phase II randomized study comparing 2 nonmyeloablative conditionings - Minitransplant-Random TBI vs TLI
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Hematological malignancies confirmed histologically and not rapidly progressing:
- •- AML in CR (defined as * 5% marrow blasts and absence of blasts in the peripheral blood);
- •- MDS with * 5% marrow blasts and absence of blasts in the peripheral blood;
- •- CML in CP;
- •- MPS not in blast crisis and not with extensive marrow fibrosis,
- •- ALL in CR;
- •- Multiple myeloma not rapidly progressing;
- •- Non-Hodgkin*s lymphoma (aggressive NHL should have chemosensitive disease);
- •- Hodgkin*s disease with chemosensitive disease.;Clinical situations
- •· Theoretical indication for a standard allo-transplant, but not feasible because:
- •- Age > 50 yrs;
- •- Unacceptable end organ performance;
- •- Patient*s refusal.
- •· Indication for a standard auto-transplant:
- •® perform mini-allotransplantation 2-6 months after standard autotransplant.;Other inclusion criteria
- •· Male or female; fertile patients must use a reliable contraception method;
- •· Age £ 75 yrs;
- •· Informed consent given by patient or his/her guardian if of minor age.;Donors:
- •· Related to the recipient (sibling, parent or child) or unrelated;
- •· Male or female;
- •· 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched;
- •· Weight > 15 Kg (because of leukapheresis);
- •· Fulfills criteria for allogeneic PBSC donation according to standard procedures;
- •· Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.
排除标准
- •· Any condition not fulfilling inclusion criteria;
- •· HIV positive;
- •· Non-hematological malignancy(ies) (except non-melanoma skin cancer) < 3 years before nonmyeloablative HCT.
- •· Life expectancy severely limited by disease other than malignancy;
- •· Administration of cytotoxic agent(s) for *cytoreduction* within three weeks prior to initiating the nonmyeloablative transplant conditioning (Exceptions are hydroxyurea and imatinib mesylate);
- •· CNS involvement with disease refractory to intrathecal chemotherapy.
- •· Terminal organ failure, except for renal failure (dialysis acceptable)
- •a. Cardiac: Symptomatic coronary artery disease or other cardiac failure requiring therapy; ejection fraction <35%; uncontrolled arrhythmia, uncontrolled hypertension;
- •b. Pulmonary: DLCO < 35% and/or receiving supplementary continuous oxygen;
- •c. Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
- •· Uncontrolled infection;
- •· Karnofsky Performance Score <70%;
- •· Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
- •· Patient is a female who is pregnant or breastfeeding;
- •· Previous radiation therapy precluding the use of 2 Gy TBI or 8 Gy TLI;;Donors:
- •· Any condition not fulfilling inclusion criteria;
- •· Unable to undergo leukapheresis because of poor vein access or other reasons.
研究者
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