Phase-II study on the value of post-transplant Cyclophosphamide after Thiotepa-based haplo-identical stem-cell transplantation for relapsed-refractory lymphoma - CHARLY

niversity Hospital Heidelberg0 个研究点目标入组 59 人开始时间: 2016年4月21日最近更新: 2023年12月19日

适应症

试验速览

暂无简介。

•1. Written informed consent obtained according to international guidelines and local laws;
•2. Male or female patients aged 18-65 years;
•3. Diagnosis of one the following NHL subtypes (PTCL, DLBCL, MCL, FL, transformed CLL)
•4. Refractoriness or early relapse (<12 months) after at least two regimens and/or auto-HSCT failure;
•5. Intent-to Thiotepa based myeloablative Haplo-HSCT because of unavailability of a fully matched SIB or MUD (10/10), within the time frame for successful HSCT as determined by disease activity;
•6. Eligible to undergo myeloablative allogeneic stem cell transplantation as judged by the treating transplant physician. E.g. patients with controlled clinically insignificant infections are eligible,
•whereas patients with active uncontrolled infections are not eligible.
•7. ECOG performance status of 0 - 1;
•8. Ability to understand the nature of the trial and the trial related procedures and to comply with them.
•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 54
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Patients with known congestive heart failure NYHA Class III and IV
•2. Known HIV infection, infectious hepatitis (type B or C) or any other uncontrolled severe infection, i.e. patients with positive HIV test or active hepatitis B should be excluded. Only patients positive for anti-HBs+ with or without anti-HBc+ are allowed to enter the study.
•Patients with hepatitis C (anti-HCV+) should be excluded;
•3. Known hypersensitivity to cyclophosphamide;
•4. Renally impaired patients with creatinine clearance < 30 ml/min (Cockcroft-Gault equation);
•5. Simultaneous participation in other clinical trials;
•6. Participation in a clinical trial within the last 14 days before the date of registration of this trial;
•7. Known abuse of medication, drugs or alcohol;
•8. Female patients who are pregnant or breast feeding;
•9. Fertile patients refusing to use safe contraceptive methods during the study.
•10. Patients with uninary outflow obstructions or clinical signs of cystitis are not eligible.

发起方

niversity Hospital Heidelberg