Status:
COMPLETED
Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Lymphoblastic Leukemia
Complete Hematologic Remission (CHR)
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
The present study aims at studying how safe and tolerable a new therapy for patients with Acute Lymphoblastic Leukemia (ALL) is. This new therapy consists of an immunotherapy, that is an approach foc...
Detailed Description
This is an open label, multicenter, phase I study of adoptive immunotherapy with enriched and expanded autologous natural killer (NK) cells for patients with Ph+ acute lymphoblastic leukemia (ALL) in ...
Eligibility Criteria
Inclusion
- Adult subjects with Ph+ ALL in CHR (1st or 2nd) with MRD positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-CHR treatment modalities.
- WHO score 0-1.
- Hematopoietic, liver and renal normal functions defined as follows:
- WBC bigger or equal to 2.000/mm3 lymphocytes bigger or equal to 500/mm3 neutrophils bigger or equal to 1.000/mm3 platelets bigger or equal to 50.000/mm3 Hb bigger or equal to 9 g/dl creatinine fewer or equal to 1.5 x ULN bilirubin fewer or equal to 1.5 x ULN AST and ALT less than 3 times the upper limit of normal. LDH less than 2 times the upper limit of normal.
- For male and female subjects of childbearing potential, agreement to use effective contraception.
- Authorization by Istituto Superiore di Sanità (ISS) according to DM 2 March 2004.
- Signed written informed consent according to ICH/EU/GCP and national local regulations.
Exclusion
- Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
- Any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
- Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
- Presence of autoimmune symptoms.
- Pregnant or lactating females.
- Simultaneous participation in another clinical trial.
- Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
Key Trial Info
Start Date :
January 28 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02185781
Start Date
January 28 2015
End Date
November 29 2021
Last Update
March 30 2023
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
ISS/AIFA
Roma, Italy
2
Ospedale S. Eugenio
Roma, Italy
3
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
4
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy