Co-infusion of haematopoietic stem cells from a haplo-identical donor and single unit unrelated cord blood in patients with a high risk of relapse: A Phase l/ll study to assess safety and to investigate the biological mechanism of the anti-tumor response - Haplo-Cord Study

niversitair Medisch Centrum Utrecht0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•All of the following five criteria:
•1) Patients with either:
•A) No standard HSCT protocol available and any of the following malignancies: NHL or HD (refractory, *2CR); relapse AML, refractory AML, MDS/SAA, ALL *CR2
•B) Relapse after first allo-HSCT with either SIB or MUD/UCB donor
•C) With a leukemia/lymphoma, MDS/SAA indication, qualifying for HSCT but without donor available according to ongoing, open study protocols (only adults): no fully matched family donor or matched (9-10/10) unrelated donor available and / or no single or double unit cord blood available with sufficient cell numbers according to ongoing, open study protocols. ;2) With having a single matching (* 4/6) umbilical CB unit available with total NC count > 1,5 E7/kg [1]
•3) Lansky / Karnofsky > 40
•4) Age 18-65 * (*<= age * 65 and 364 days )
•5) Signed Informed Consent

•- geen getekende toestemingsverklaring
•- Lansky < 40
•- No cord blood unit available wih <=4/6 match en a minimum cell dose of > 1,5 x 10E7 Nucleated cells /kg
•- Creatinine clearance < 40 ml/min
•- cardiac dysfunction (SF < 45%) (Ejection fraction < 45%), unstable angina, or unstable cardiac arrhythmias
•-Pulmonary function test VC, FEV1 and/ or DOC< 50%

发起方

niversitair Medisch Centrum Utrecht