Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK)… (NCT02185781) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
Italy6 participantsStarted 2015-01-28
Plain-language 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 focusing on the immune system, and it targets ALL patients in complete remission but who may still have the disease at a cellular level (this is called 'minimal residual disease').
For any further information, please, discuss with your treating physician.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Sanità (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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine the MTD and the recommended final dose (RD) to be used for further investigations.
Timeframe: One year from start of treatment.
Trial details
NCT IDNCT02185781
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto