An Open-Label Multicenter Study of the Effects of Remission Maintenance Therapy with Ceplene (Histamine Dihydrochloride) Given in Conjunction with Low-Dose Interleukin-2 (IL-2 Proleukin) on Immune Response and Minimal Residual Disease (MRD) in Adult Patients with Acute Myeloid Leukemia in First Complete Remission (CR1) - EPC2008-02 Ceplene and IL-2 in AM

• Conditions: Patients affected by Acute Myeloid Leukemia; MedDRA version: 12.1Level: LLTClassification code 10000887Term: Acute myeloid leukemia in remission

• Registration Number: EUCTR2009-012083-14-IT
• Lead Sponsor: EpiCept Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-19
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

AML patients in CR1 who have been cytogenetically well-characterized (using molecular cytogenetic techniques, eg, RQ-PCR) at diagnosis. Patients may be considered eligible if they have not had this assessment performed at diagnosis provided a viable diagnostic bone marrow sample is available on which this testing may be performed. Characterization of leukemia immunophenotypic fingerprint at diagnosis using MFC techniques. 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 6 weeks following the date of the last dose of consolidation or conditioning chemotherapy for AML, or following ASCT. 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, refer to Appendix 1). 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have undergone or are planned for allogeneic stem cell transplantation. 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. Prior history of 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 hypersensitivity to histamine or histamine products, severe allergies to food or contrast media requiring treatment within the last five years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified