Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)

• Register: ClinicalTrials.gov
• Last refreshed on: 10 April 2023
• Main ID: NCT02185781
• Date of registration: 07/07/2014
• Prospective Registration: Yes
• Primary sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Public title: Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
• Scientific title: Phase I Protocol 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
• Date of first enrolment: January 28, 2015
• Target sample size: 6
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02185781
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Italy

Contacts

• Name: Roberto Foà
• Affiliation: Policlinico Umberto I di Roma

• Name: Giovanni Torelli
• Affiliation: Policlinico Umberto I di Roma

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Sanita` (ISS) according to DM 2 March 2004.

- Signed written informed consent according to ICH/EU/GCP and national local
regulations.

Exclusion Criteria:

- 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.



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Persistent/Recurrent Minimal Residual Disease (MRD)

Acute Lymphoblastic Leukemia

Complete Hematologic Remission (CHR)

Intervention(s)

Other: Autologous NK cells infusions

Primary Outcome(s)

To determine the MTD and the recommended final dose (RD) to be used for further investigations. [Time Frame: One year from start of treatment.]

Secondary Outcome(s)

Number of adverse events. [Time Frame: Two years from start of treatment.]

Number of patients able to complete the study. [Time Frame: One year from start of treatment.]

Number of patients alive after treatment conclusion. [Time Frame: Two years from treatment start.]

Number of patients alive without progression. [Time Frame: One year from treatment start.]

Number of patients who respond to treatment. [Time Frame: One year from treatment start.]

Number and characteristics of immunologic modifications. [Time Frame: One year from start of treatment.]

Time to complete enrolment. [Time Frame: Three years from first patient enrollment.]

Secondary ID(s)

LAL 2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors