Maintenance Therapy With Ceplene® (Histamine) and IL-2 on Immune Response and MRD in Acute Myeloid Leukemia
NCT ID: NCT01347996
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
84 participants
INTERVENTIONAL
2009-07-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Primary:
1. To assess the quantitative and qualitative pharmacodynamic effects of Ceplene plus low-dose IL-2 (Ceplene/IL-2) by monitoring T and natural killer (NK) cell phenotypes and their functionality after the first and third treatment cycles in adult patients with acute myeloid leukemia (AML) in first complete remission (CR1).
2. To evaluate minimal residual disease (MRD) in AML patients receiving Ceplene/IL-2.
Secondary:
To document, in adult AML patients in CR1 treated with Ceplene/IL-2:
1. Leukemia-free survival (LFS) after a follow-up period of up to two years.
2. The safety of Ceplene/IL-2 therapy.
3. The potential relationship of Ceplene/IL-2 effects on T and NK cell phenotypes and their functionality to MRD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
histamine dihydrochloride and IL-2
histamine and IL-2 subcutaneous injections
histamine dihydrochloride and IL-2
Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg \[16,400 IU/kg\] body weight twice daily for 10, 21 day cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
histamine dihydrochloride and IL-2
Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg \[16,400 IU/kg\] body weight twice daily for 10, 21 day cycles
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Bone marrow examination confirming CR (defined as less than 5% blasts in a normocellular bone marrow).
* Eighteen years of age or older.
* Patients have received any form of induction and consolidation therapy as per standard practice at the institution, including autologous stem cell transplantation (ASCT).
* Within 8 weeks following the date of the last dose of consolidation or conditioning chemotherapy for AML, or following ASCT.
* Patients not undergoing consolidation therapy must have been in CR1 for at least one month prior to enrollment.
* Platelet count recovered after chemotherapy to ≥75 x 109/L, and Partial Thromboplastin Time (PTT) within normal limits.
* WBC ≥1.5 x 109/L and LFTs (to include SGPT \[ALAT\] or SGOT \[AST\] and bilirubin) should not exceed twice the upper limit of normal.
* Serum creatinine less than or equal to 1.5 times the upper normal limit.
* Able to function without significant decrease in daily activities (WHO Performance Status 0 - 1 or Karnofsky ≥70).
* Life expectancy of more than three months and able to undergo routine outpatient evaluations for efficacy, safety, and/or compliance.
* Women of childbearing potential must be practicing barrier or oral contraception, for the duration of the treatment, or documented as surgically sterile or one year post-menopausal.
* If female, be non-nursing, non-pregnant and have a negative pregnancy test within two weeks of starting study drug.
* The patient must be informed of the investigational nature of the study and written informed consent obtained.
Exclusion Criteria
* Patients with M3 as an AML subtype.
* Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease.
* Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin.
* Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study.
* History of seizures, central nervous system disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol.
* Patients unable to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.
* Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis).
* Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history or bleeding.
* Patients requiring active treatment for hypotension.
* Medical, sociologic, or psychological impediment to probable compliance with the protocol.
* Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
* Patients with a history of histamine hypersensitivity, severe allergies to food or contrast media requiring treatment within the last five years.
* Patients unable to provide written consent.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
EpiCept Corporation
INDUSTRY
Cytovia, Inc.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robin FOA, MD, PhD
Role: STUDY_CHAIR
Università degli Studi di Roma "La Sapienza" Dipartimento di Biotecnologie Cellulari ed Ematolgia
Mats L Brune, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska Academy University of Gothenburg, Gothenburg, Sweden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sahlgrenska Academy, University of Gothenburg
Gothenburg, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hussein BA, Hallner A, Wennstrom L, Brune M, Martner A, Hellstrand K, Bernson E, Thoren FB. Impact of NK Cell Activating Receptor Gene Variants on Receptor Expression and Outcome of Immunotherapy in Acute Myeloid Leukemia. Front Immunol. 2021 Dec 9;12:796072. doi: 10.3389/fimmu.2021.796072. eCollection 2021.
Grauers Wiktorin H, Aydin E, Christenson K, Issdisai N, Thoren FB, Hellstrand K, Martner A. Impact of IL-1beta and the IL-1R antagonist on relapse risk and survival in AML patients undergoing immunotherapy for remission maintenance. Oncoimmunology. 2021 Jul 25;10(1):1944538. doi: 10.1080/2162402X.2021.1944538. eCollection 2021.
Grauers Wiktorin H, Nilsson MS, Kiffin R, Sander FE, Lenox B, Rydstrom A, Hellstrand K, Martner A. Histamine targets myeloid-derived suppressor cells and improves the anti-tumor efficacy of PD-1/PD-L1 checkpoint blockade. Cancer Immunol Immunother. 2019 Feb;68(2):163-174. doi: 10.1007/s00262-018-2253-6. Epub 2018 Oct 12.
Sander FE, Nilsson M, Rydstrom A, Aurelius J, Riise RE, Movitz C, Bernson E, Kiffin R, Stahlberg A, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Role of regulatory T cells in acute myeloid leukemia patients undergoing relapse-preventive immunotherapy. Cancer Immunol Immunother. 2017 Nov;66(11):1473-1484. doi: 10.1007/s00262-017-2040-9. Epub 2017 Jul 18.
Bernson E, Hallner A, Sander FE, Wilsson O, Werlenius O, Rydstrom A, Kiffin R, Brune M, Foa R, Aurelius J, Martner A, Hellstrand K, Thoren FB. Impact of killer-immunoglobulin-like receptor and human leukocyte antigen genotypes on the efficacy of immunotherapy in acute myeloid leukemia. Leukemia. 2017 Dec;31(12):2552-2559. doi: 10.1038/leu.2017.151. Epub 2017 May 22.
Rydstrom A, Hallner A, Aurelius J, Sander FE, Bernson E, Kiffin R, Thoren FB, Hellstrand K, Martner A. Dynamics of myeloid cell populations during relapse-preventive immunotherapy in acute myeloid leukemia. J Leukoc Biol. 2017 Aug;102(2):467-474. doi: 10.1189/jlb.5VMA1116-455R. Epub 2017 Feb 24.
Sander FE, Rydstrom A, Bernson E, Kiffin R, Riise R, Aurelius J, Anderson H, Brune M, Foa R, Hellstrand K, Thoren FB, Martner A. Dynamics of cytotoxic T cell subsets during immunotherapy predicts outcome in acute myeloid leukemia. Oncotarget. 2016 Feb 16;7(7):7586-96. doi: 10.18632/oncotarget.7210.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPC2008-02
Identifier Type: -
Identifier Source: org_study_id