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 (AML) in First Complete Remission (CR1)

MEDA Pharma GmbH & Co. KG0 sites150 target enrollmentMay 4, 2009

Overview

No summary available.

Registry

who.int

Start Date

May 4, 2009

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•AML patients in CR1 whose AML subtype has been well\-characterized using conventional karyotyping and molecular genetic techniques (eg, RQ\-PCR) at diagnonsis. Patients may be considered eligible if they have not had this assessment performed at diagnosis provided that stored samples of a diagnostic genetic material (DNA/RNA) from blood and BM are available that can be assayed for the presence of markers such as WT1 and/or AML\-specific genetic markers.
•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 consilidation 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, refer to Appendix 1\).

•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.
•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.