Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes
Information source: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelodysplastic Syndromes
Intervention: Ceplene®, IL-2, Azacitidine (Drug); Azacitidine (Drug)
Phase: Phase 1/Phase 2
Status: Withdrawn
Sponsored by: Groupe Francophone des Myelodysplasies Official(s) and/or principal investigator(s): Céline BERTHON, MD, Principal Investigator, Affiliation: Groupe Francophone des Myelodisplasies Bruno QUESNEL, MD, PhD, Principal Investigator, Affiliation: Groupe Francophone des Myelodisplasies Pierre Fenaux, MD, Principal Investigator, Affiliation: Groupe francophone des Myelodisplasies
Summary
A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and
tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS)
who achieved a hematological response after 6 cycles of azacitidine. After approval by an
independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an
open label randomized phase II study designed to characterize the efficacy, safety, and
tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher
risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of
azacitidine.
Clinical Details
Official title: A Phase I and 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 Who Achieved Hematological Response to Azacitidine
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to progression according to IWG2006 criteria
Secondary outcome: Types and numbers of adverse events occuring in all treated patientsImprovement of the quality and the duration of responses compared to maintenance with AZA alone
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Must understand and voluntarily sign an informed consent form
- Must be able to adhere to the study visit schedule and other protocol requirements
- Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria
for intermediate-2 or high-risk disease
- Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria)
after 6 cycles of Azacitidine.
- Patients must have ECOG performance status (PS) of 0 - 2.
- 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
- 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)
- Serum total bilirubin < 1. 5 mg/dL. (except for unconjugated hyperbilirubinemia due to
Gilbert's disease or secondary to MDS).
Exclusion Criteria:
- Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
- 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
- Patients receiving any other standard or investigational cytotoxic treatment for
their hematologic malignancy
- Any medical condition which in the opinion of the investigator places the patient at
an unacceptably high risk for toxicities
- 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
- 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
- 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
- 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 of bleeding
- 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.
Locations and Contacts
CHU d'Amiens, Amiens 80054, France
CHU Angers, Angers 43033, France
CH d'Avignon, Avignon 84000, France
Hôpital de la Côte Basque, Bayonne 64100, France
Hopital Avicenne, Bobigny 93009, France
CHU de Caen, Caen 14033, France
CHU de, Clermont Ferrand 63058, France
Centre Hospitalier Sud-Francilien, Corbeil-Essonnes 91106, France
CHU Grenoble, Grenoble 38043, France
Hôpital Versailles, Le Chesnay 78157, France
CHRU Hurriez, Lille 59057, France
Hôpital Saint Vincent, Lille 59020, France
CHRU Limoges, Limoges 87046, France
Hôpital Edouard Heriot, dpt Hématologie Clinique, Lyon 69437, France
Hôpital Paoli-Calmettes, Marseille 13273, France
Hematology Dpt, Hopital de l'Hotel Dieu, Nantes 44093, France
CHU Archet, Nice 06202, France
Hopital Saint Louis, Paris 75475, France
Hôpital Saint Antoine, Paris 75571, France
Centre Hospitalier Joffre, Perpignan 66046, France
Hôpital Jean-Bernard, Poitiers 86021, France
CHRU de Reims, Reims 51092, France
Centre Henri Bequerel, Rouen 76038, France
Centre Hospitalier Universitaire de STRASBOURG, Strasbourg 67098, France
Hopital Purpan Service d'Hématologie Clinique, Toulouse, France
Hopital Bretonneau, Tours 37044, France
CHU de Bicêtre, Le Kremlin-Bicêtre, Ile de France 94275, France
CHU Cochin, Paris, Ile de France 75679, France
Additional Information
Starting date: March 2011
Last updated: March 19, 2014
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