Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
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|ClinicalTrials.gov Identifier: NCT02185781|
Recruitment Status : Unknown
Verified August 2018 by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Recruitment status was: Recruiting
First Posted : July 10, 2014
Last Update Posted : August 6, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia Complete Hematologic Remission (CHR) Persistent/Recurrent Minimal Residual Disease (MRD)||Other: Autologous NK cells infusions||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||November 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
|Experimental: Autologous NK Cells infusions||
Other: Autologous NK cells infusions
Each patient will receive repeated intravenous (IV) infusions of escalating doses of expanded autologous NK cells.
The initial dose will be 1 x 106/kg of recipient body weight (BW), followed by half log increments of the dose level for each infusion, to a maximum of 1 x 108/kg of recipient BW or until they experience any toxicity, for a maximum of 5 infusions. The minimum interval between each infusion will be 28 days. No conditioning therapies will be administered before the infusion of the expanded NK cells. Patients may receive TKI maintenance.
- To determine the MTD and the recommended final dose (RD) to be used for further investigations. [ Time Frame: One year from start of treatment. ]
- Number of adverse events. [ Time Frame: Two years from start of treatment. ]To assess the safety and tolerabilty of the treatment by evaluating frequency, type and intensity of adverse events (AEs) according to the CTC classification, as well as the patients' compliance and clinically relevant changes in the laboratory parameters.
- Number of patients able to complete the study. [ Time Frame: One year from start of treatment. ]To evaluate the feasibility of the procedure in terms of number of patients able to complete the study and time to complete enrolment.
- Time to complete enrolment. [ Time Frame: Three years from first patient enrollment. ]Protocol feasibility.
- Number and characteristics of immunologic modifications. [ Time Frame: One year from start of treatment. ]To assess the immunologic modifications induced by the procedure; in particular, to verify the functional and cytotoxic activity against tumor cell lines and primary fresh allogeneic and autologous blasts cryopreserved at diagnosis, and to monitor the frequency, phenotype and activation status of the infused NK cell populations by flow cytometry analyses, Chromium release cytotoxic assays and intracellular cytokine production.
- Number of patients who respond to treatment. [ Time Frame: One year from treatment start. ]To evaluate the clinical response to the treatment in terms of control of MRD with quantitative (Q)- RT-PCR.
- Number of patients alive after treatment conclusion. [ Time Frame: Two years from treatment start. ]To evaluate OS in terms of number of patients alive.
- Number of patients alive without progression. [ Time Frame: One year from treatment start. ]To evaluate the TTP in terms of number of patients alive without progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185781
|Contact: Paola Fazi, PhDemail@example.com|
|Contact: Enrico Creafirstname.lastname@example.org|
|ISS/AIFA||Not yet recruiting|
|Contact: Annarita Meneguz|
|Principal Investigator: Annarita Meneguz|
|Ospedale S. Eugenio||Recruiting|
|Contact: Paolo DE FABRITIIS, Pr.|
|Principal Investigator: Paolo DE FABRITIIS, Pr.|
|Sub-Investigator: Benedetta Neri|
|Università Cattolica del Sacro Cuore - Policlinico A. Gemelli||Recruiting|
|Contact: Livio Pagano|
|Principal Investigator: Livio Pagano|
|Sub-Investigator: Luana Fianchi|
|Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia||Recruiting|
|Contact: Roberto Foà|
|Principal Investigator: Roberto Foà|
|Sub-Investigator: Giovanni Torelli|
|Università degli Studi - Policlinico di Tor Vergata||Not yet recruiting|
|Contact: Adriano Venditti|
|Principal Investigator: Adriano Venditti, dr.|
|Sub-Investigator: Ilaria Del Principe, Dr.|
|Study Chair:||Roberto Foà||Policlinico Umberto I di Roma|
|Study Director:||Giovanni Torelli||Policlinico Umberto I di Roma|