Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

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.
Hematopoietic, liver and renal normal functions defined as follows:
WHO score 0-1.
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.
Hematopoietic, liver and renal normal functions defined as follows:
WHO score 0-1.

Exclusion Criterias

Pregnant or lactating females.
Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
...
Pregnant or lactating females.
Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
Presence of autoimmune symptoms.
Any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
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.

Summary

Conditions
  • Acute Lymphoblastic Leukemia
  • Complete Hematologic Remission (CHR)
  • Persistent/Recurrent Minimal Residual Disease (MRD)
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 60 years and 125 years
Gender
Both males and females

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 complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) ≥6...

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 complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) ≥60 years or not eligible for other post-CHR treatment modalities. The study will investigate the safety and tolerability of a new type of NK-based immunotherapy based on the infusion of escalating doses of ex-vivo expanded autologous NK cells in Ph+ ALL patients. A maximum of 6 patients will be enrolled in two different steps. No conditioning therapies will be administered before the infusion of the expanded NK cells. Patients may receive tyrosine kinase inhibitor (TKI) maintenance.

Inclusion Criterias

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.
Hematopoietic, liver and renal normal functions defined as follows:
WHO score 0-1.
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.
Hematopoietic, liver and renal normal functions defined as follows:
WHO score 0-1.

Exclusion Criterias

Pregnant or lactating females.
Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
...
Pregnant or lactating females.
Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
Presence of autoimmune symptoms.
Any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
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.

Locations

Roma
Roma
Roma
Roma
Roma
...
Roma
Roma
Roma
Roma
Roma

Tracking Information

NCT #
NCT02185781
Collaborators
Not Provided
Investigators
Study Chair: Roberto Foà Policlinico Umberto I di Roma Study Director: Giovanni Torelli Policlinico Umberto I di Roma