EUCTR2015-004813-26-ES
Active, not recruiting
Phase 1
ong Term Follow Up for Patients who have received Allogeneic Stem Cell Transplantation of NiCord®/CordIn™, Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells
ConditionsHigh risk haematological malignanciesHemoglobinopathiesMedDRA version: 18.1Level: LLTClassification code 10025316Term: Lymphoma NOSSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10054658Term: ThalassemiaSystem Organ Class: 100000004850MedDRA version: 18.1Level: LLTClassification code 10009015Term: Chronic 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: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- High risk haematological malignanciesHemoglobinopathies
- Sponsor
- Gamida Cell Ltd
- Enrollment
- 76
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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