A phase I study of azacitidine with Ceplene/interleukin-2 followed by a randomized phase II study of the efficacy and safety of maintenance treatment with azacitidine with or without Ceplene/interleukin-2 in patients with higher risk myelodysplastic syndromes (MDS) who achieved hematological response to azacitidine. - GFM-Aza-ceplene

• Conditions: Myelodysplastic syndromes; MedDRA version: 12.1Level: LLTClassification code 10028533Term: Myelodysplastic syndrome

• Registration Number: EUCTR2010-019709-41-FR
• Lead Sponsor: Groupe Francophone des Myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age = 18 years
2.Must understand and voluntarily sign an informed consent form
3.Must be able to adhere to the study visit schedule and other protocol requirements
4.Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria for intermediate-2 or high-risk disease
5.Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of Azacitidine.
6.Patients must have ECOG performance status (PS) of 0 – 2.
7.Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
Creatinine clearance >50 ml/min
8. Creatinine clearance >50 ml/min
9.Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) < 3.0 x upper limit of normal (ULN)
10.Serum total bilirubin < 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to Gilbert’s disease or secondary to MDS).

11. Women of child-bearing potential
Agree to use, and to be able to comply with, effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy.

12. Male patients must :
- Agree the need for the use of a condom if engaged in sexual activity with a woman of
childbearing potential during the entire period of treatment, even if disruption of treatment
and during 3 months after end of treatment.
- Agree to learn about the procedures for preservation of sperm before starting treatment.

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

1.Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C

2.Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

3.Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy

4.Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities

5.Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years

6.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

7.History of seizures, central nervous disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the investigator

8.Prior history of 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 of bleeding

10.Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents

11.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

12. Antecedent of allogeneic bone marrow transplantation

Study & Design

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