A Phase l/ll study to assess safety of co-infusion of haematopoietic stem cells from a haplo-identical donor and a single unit unrelated cord blood in high risk patients - Cord-Haplo
- Conditions
- All patients (0-65y) with a malignancy qualifying for allogenic hematopoietic stem cell transplantation (HSCT) who either (and/or)- are not eligible to other ongoing allo-HSCT protocols, because of disease or disease stage- relapsed after 1st transplant with a standerd allo HSCT protocol- have no conventional related or unrelated donor available
- Registration Number
- EUCTR2010-019529-33-NL
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
All of the following five criteria:
1)All patients with a malignancy qualifying for allogenic hematopoietic stem cell transplantation (HSCT) (based on national or international study protocols) and either:
-Relapse after first transplant with a SIB or MUD/UCB donor
-Having NHL or HD (refractory, =2CR) for which no standard allo-transplantation protocols are available, or ALL =CR2 if not eligible to other running SCT protocols.
-Having relapse AML/ refractory AML
-Problems finding a donor: 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) having a single matching (= 4/6) umbilical CB unit available with total NC count > 1,5 E7/kg [22]
3) Lansky / Karnofsky > 40
4) Age 0-65 * (*= age = 65 and 364 days )
5) Signed Informed Consent
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the feasibility and safety (TRM/ a GVHD incidence) of co-infusion of selected haematopoietic cells from a haplo-identical donor and a single unit cord blood unit. <br>;Secondary Objective: engraftment rate<br>full cord blood chimerism<br>Immune reconstitution<br>number of viral reactivations;Primary end point(s): •The cumulative incidence of TRM (non relapse mortality < 100 days)<br>•Acute- GVHD (Grades II-IV: Gluckberg Criteria)<br>
- Secondary Outcome Measures
Name Time Method