临床试验/NCT01597219

NCT01597219已完成2 期

A UK Multicentre Study of Haploidentical Stem Cell Transplantation in Patients With Haematological Malignancies

University College, London12 个研究点分布在 1 个国家目标入组 77 人开始时间: 2013年3月1日最近更新: 2024年5月3日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: University College, London
入组人数: 77
试验地点: 12
主要终点: Overall survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial investigates stem cell transplants from partially mismatched donors in patients with blood and bone marrow cancers. The trial will test two kinds of transplants - a full intensity transplant using a high dose of radiotherapy and chemotherapy, and a reduced intensity transplant with lower doses of chemotherapy and radiotherapy. Patients will be entered for the treatment pathway that is most appropriate for their level of health and fitness

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 16 Years 至 70 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient Inclusion Criteria
•Eligible for an allogeneic transplant in line with the current BSBMT indications for transplant criteria (http://bsbmt.org/indications-table/) accepted by Commissioners
•Adequate physical function
•Cardiac: LVEF at rest ≥45%, or shortening fraction ≥25%
•Hepatic: Bilirubin ≤35mmol/l; AST/ALT and alkaline phosphatase <5 x ULN
•Renal: Serum creatinine within normal range for age, or if serum creatinine outside normal range for age, creatinine clearance or GFR >40ml/min/1.73m2
•Pulmonary: FEV1, FVC, DLCO (diffusion capacity) >50% predicted (corrected for haemoglobin); if clinically unable to perform pulmonary function tests then O2 saturation >92% on room air
•Performance status: Karnofsky score ≥60%
•Donor available aged ≥16 years
•Needs an urgent transplant where a 10/10 HLA matched sibling or unrelated donor is unavailable in a timely manner. An unrelated donor search is not required for a patient to be eligible if the clinical situation dictates an urgent transplant. Clinical urgency is defined as 6-8 weeks from referral to transplant centre or low likelihood of finding a matched unrelated donor
•HLA typing will be performed at high resolution (allelic) for the HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB1 loci. A minimum match of 5/10 is required
•The donor and recipient must be identical as determined by high resolution typing at at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1 and HLA-DQB
•Fulfilment of this criterion is sufficient evidence that the donor and recipient share one HLA haplotype and typing of additional family members is not required.
•Patient must have received cytotoxic chemotherapy within 3 months of the consent date (measured from the start date of the most recent cycle of chemotherapy) except patients with aplastic anaemia, unless otherwise agreed by the TMG (see section 5.3.4). The use of monoclonal antibody therapy may be considered cytotoxic chemotherapy, but must be agreed by the TMG
•Written informed consent
•Donor Inclusion Criteria
•Donor must be an HLA-haploidentical first degree relative of the patient. Eligible donors include biological parents, siblings, children or half-siblings
•Age ≥16 years
•Donors must meet the collection centre's usual selection criteria for related allogeneic HPC donors

排除标准

•HLA matched, related donor able to donate
•Autologous haematopoietic stem cell transplant <3 months prior to enrolment
•Pregnancy or breastfeeding
•Uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiological findings), the inclusion of patients with an uncontrolled viral or fungal infection can be agreed by the TMG
•Serious psychiatric or psychological disorders
•Absence or inability to provide informed consent
•Severe comorbidity (HCT-CI comorbidity score of 3 or more) or disease that prevents treatment with chemotherapy, unless otherwise agreed by the TMG
•Positive anti-donor HLA antibody
•Unable to receive 2Gy TBI (RIC pathway) or 12Gy TBI (MAC pathway)
•Patients with graft rejection following a previous allograft from either adult or cord blood donors
•Donor Exclusion Criteria
•Positive anti-donor HLA antibody in the recipient
•Pregnancy or recent birth (within 6 months prior to donating cells)

研究组 & 干预措施

Reduced intensity haploidentical transplant

Experimental

Fludarabine 30mg/m2 IV days -6 to -2 Cyclophosphamide 14.5 mg/kg IV days -6 and -5 Total body irradiation 2Gy day -1 Stem cell transplant: day 0 Cyclophosphamide 50mg/kg days +3 & +4

干预措施: Reduced intensity haplodentical stem cell transplant (Procedure)

Myeloablative haploidentical stem cell transplant

Experimental

Total body irradiation 12Gy in 8 fractions days -9 to -6 Donor lymphocyte infusion day -6 Cyclophosphamide 60mg/kg IV days -3 & -2 Stem cell transplant day 0

干预措施: Myeloablative haploidentical stem cell transplant (Procedure)

结局指标

主要结局

Overall survival

时间窗: 1 year post transplant

次要结局

未报告次要终点

研究者

发起方

University College, London

申办方类型

Other

责任方

Sponsor

研究点 (12)

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