ong term follow up for patients who have received NiCord/CordIn, stem cells from donated umbilical cord bloodthat were grown in a laboratory to expand their number
Phase 1
- Conditions
- High risk haematological malignanciesHemoglobinopathiesMedDRA version: 18.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10009015Term: Chronic myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10025316Term: Lymphoma NOSSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10054658Term: ThalassemiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]MedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10040645Term: Sickle cell disease NOSSystem Organ Class: 100000004850MedDRA version: 18.1Level: LLTClassification code 10028534Term: Myelodysplastic syndrome NOSSystem Organ Class: 100000004864
- Registration Number
- EUCTR2015-004813-26-ES
- Lead Sponsor
- Gamida Cell Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Anyone who has received a NiCord/CordIn transplant, signed the consent for this study, and completed study specific follow up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 31
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
A patient is not eligible if during the NiCord/CordIn transplant protocol, any of the following occurred before or on the completion of the last study visit (d365):
Disease relapse/progression
Autologous Recovery
Graft Failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation;Secondary Objective: Describe long term sustained engraftment of NiCord/CordIn transplantation<br>Describe survival and disease free survival in NiCord/CordIn infused patients<br>Describe characteristics of patients with secondary graft failure or disease relapse<br>Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn <br>Describe incidence of chronic GvHD<br>;Primary end point(s): Describe the clinical outcomes of patients who have received a NiCord/CordIn transplantation ;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows:<br>Visit #1: 2 years post NiCord/CordIn infusion<br>Visit #2: 3 years post NiCord/CordIn infusion<br>Visit #3: 4 years post NiCord/CordIn infusion<br>Visit #4: 5 years post NiCord/CordIn infusion<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Describe long term sustained engraftment of NiCord/CordIn transplantation<br>- Describe survival and disease free survival in NiCord /CordIn infused patients<br>- Describe characteristics of patients with secondary graft failure or disease relapse<br>-Describe long term immune reconstitution characteristics of patients who receive NiCord/CordIn<br>-Describe incidence of chronic GvHD<br>;Timepoint(s) of evaluation of this end point: The study includes 4 timepoints as follows:<br>Visit #1: 2 years post NiCord/CordIn infusion<br>Visit #2: 3 years post NiCord/CordIn infusion<br>Visit #3: 4 years post NiCord/CordIn infusion<br>Visit #4: 5 years post NiCord/CordIn infusion<br>