A Study to Assess the Effects of Remission Maintenance Therapy with Ceplene®, Given 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)
- Conditions
- Acute Myeloid Leukemia in First Complete Remission (CR1)MedDRA version: 15.1Level: LLTClassification code 10000887Term: Acute myeloid leukemia in remissionSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-012083-14-BE
- Lead Sponsor
- Meda Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
1. AML patients in CR1 whose AML subtype has been well-characterized using conventional karyotyping and molecular genetic techniques (eg, RQ-PCR) at diagnosis. Patients may be considered eligible if they have not had this assessment performed at diagnosis provided that stored samples of 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.
2. Bone marrow examination confirming CR (defined as less than 5% blasts in a normocellular bone marrow).
3. Eighteen years of age or older.
4. Patients have received any form of induction and consolidation therapy as per standard practice at the institution, including autologous stem cell transplantation (ASCT).
5. Screening within 12 weeks following the date of the last dose of consolidation or conditioning chemotherapy for AML, or following ASCT.
6. Patients not undergoing consolidation therapy must have been in CR1 for at least 30 days prior to enrollment.
7. Platelet count recovered after chemotherapy to =75 x 109/L.
8. WBC =1.5 x 109/L.
9. LFTs (to include SGPT [ALAT], SGOT [AST] and bilirubin) should not exceed twice the upper limit of normal.
10. Serum creatinine less than or equal to 1.5 times the upper normal limit.
11. Able to function without significant decrease in daily activities (Karnofsky =70, refer to Appendix 1).
12. Life expectancy of more than three months and able to undergo routine outpatient evaluations for efficacy, safety, and/or compliance.
13. Females of childbearing potential (FCBP) and males having intercourse with FCBP must agree to comply with using an effective contraceptive method for the duration of the treatment (FCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months).
14. All females must be non-nursing, non-pregnant and have a negative pregnancy test within two weeks of starting study drugs.
15. 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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1. Patients who have undergone or are planned for allogeneic stem cell transplantation.
2. Patients with M3 as an AML subtype.
3. 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.
4. Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin.
5. Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study.
6. 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.
7. Patients unable to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.
8. Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis).
9. Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history or bleeding.
10. Patients requiring active treatment for hypotension.
11. Medical, sociologic, or psychological impediment to probable compliance with the protocol.
12. Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents.
13. Patients with a history of histamine hypersensitivity, severe allergies to food or contrast media requiring treatment within the last five years.
14. Patients unable to provide written consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method