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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Status: Withdrawn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 patients

Improvement 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

Page last updated: August 23, 2015

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