A Study of Azacitidine in Myelodysplastic Syndrome (MDS) Associated to Systemic Auto-immune and Inflammatory Disorders
NCT ID: NCT02985190
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2017-01-26
2022-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azacitidine 75mg/m²/day
Azacitidine 75mg/m²/j subcutaneously daily for 7 days every 4 weeks for a minimum of 6 cycles (unless overt disease progression, especially to Acute Myeloid Leukemia (AML) occure before 6 cycles) Azacitidine will be continued after 6 cycles
* in patients with hematological response of myelodysplastic syndrome to azacitidine according to IWG2006 criteria by 6 cycles (Complete Response (CR), Partial Response (PR), marrow Complete Response (CRm), stable disease with Hematological Improvment (HI)), for another 6 cycles
* in patients with complete or partial response of Systemic Auto-Immune Disorders (SAID) after 6 cycles of Azacitidine, even if Myelodysplastic Syndrome remains only stable per IWG2006 criteria
Azacitidine
Azacitidine at 75mg/m²/j for 7 days.
Interventions
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Azacitidine
Azacitidine at 75mg/m²/j for 7 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years at the time of signing the informed consent form
* Must be able to adhere to the study visit schedule and other protocol requirements
* MDS or CMML or AML with 20-30% marrow blasts using 2008 WHO classification, with any of the following characteristics :
1. IPSS intermediate 2 or high, including AML with 20 to 30% marrow blasts and CMML with WBC\<13G/L and marrow blasts \>10%,
2. IPSS low or int 1 in need of treatment (transfusion dependent anemia resistant to ESAs and/or platelets below 30 G/l or below 50 G/l with bleeding or platelet transfusion requirement, and/or ANC \< 0.5 G/l with infectious complications)
3. Documented (by cytogenetic or molecular analysis) MDS /CMML not meeting those criteria, but with at least one significant cytopenia (Hb \<10 g/dl, platelets \<50G/l, ANC \<1 G/l). In this situation, the underlying SAID should be severe and have resisted to a second line treatment (following steroids), if such treatment can be proposed for this particular SAID. Those cases should be discussed prior to inclusion with the trial sponsors complications)
* SAID-associated with MDS defined according to usual international criteria for each SAID (ie ACR criteria for systemic lupus, Chapel Hill classification for systemic vasculitis, etc…)
* Steroid dependence and/or resistance of SAID (steroid dependence being defined as the impossibility to decrease steroids during at least 2 months below 15 mg/day; steroid resistance as no response of SAID to at least 1 mg/kg/day of prednisone equivalent during one month)
* Ineligibility for allogeneic stem cell transplantation during the following 12 months
* Wash-out at least 6 months since a previous treatement with Lenalidomide
* No previous use of hypomethylating agents
* Life expectancy ≥ 6 months
* Adequate liver function (serum transaminases ≤ 3N)
* Adequate renal function (creatinine clearance with MDRD formula \> 30 ml/min)
* 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. Lactating patients are excluded.
* 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.
* 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.
Exclusion Criteria
* Creatinine clearance with MDRD formula \< 30 ml/min
* Serum total bilirubin, or serum transaminases \> 3.0 x upper limit of normal (ULN) (except for unconjugated hyperbilirubinemia due to Gilbert's disease or secondary to MDS)
* Known hypersensitivity to the active substance or to any of the excipients of AZA
* History of severe congestive heart failure, clinically unstable cardiac or pulmonary disease
* Previous treatment with hypomethylating agents
* Life-expectancy of less than six months because of another debilitating disease
* Uncontrolled invasive fungal infection at time of registration or active serious infection not controlled by oral or intravenous antibiotics
* Known positive for HIV or acute infectious hepatitis, type B or C
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study.
* Active cancer or 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
* Pregnant or lactating females
* No affiliation to an insurance system
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Arsene MEKINIAN, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Antoine Hospital
Olivier FAIN, PHD
Role: PRINCIPAL_INVESTIGATOR
Saint Antoine Hospital
Pierre FENAUX, PHD
Role: STUDY_DIRECTOR
Saint-Louis Hospital, Paris, France
Locations
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CHU Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Centre hospitalier Victor Dupouy
Argenteuil, , France
CH Henri Duffaut d'Avignon
Avignon, , France
Centre hospitalier de la Côte Basque
Bayonne, , France
Hôpital Nord Franche-Comté
Belfort, , France
Hôpital Avicenne
Bobigny, , France
Centre Hospitalier de Boulogne Sur Mer
Boulogne-sur-Mer, , France
CHRU de Brest - Hôpital Morvan
Brest, , France
CHU Côte de Nacre
Caen, , France
CH René Dubos
Cergy-Pontoise, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
CHU Estaing
Clermont-Ferrand, , France
CHSF Gilles de Corbeil
Corbeil-Essonnes, , France
CHU Henri Mondor
Créteil, , France
CHU François Mitterrand
Dijon, , France
CHU de Grenoble
Grenoble, , France
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, , France
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, , France
CH Le Mans
Le Mans, , France
Centre Hospitalier de Lens
Lens, , France
Hôpital Saint Vincent de Paul
Lille, , France
Hôpital Claude Huriez
Lille, , France
CHRU de Limoges - Hôpital Dupuytren
Limoges, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier de Meaux
Meaux, , France
CH de Mont de Marsan
Mont-de-Marsan, , France
Clinique Beausoleil
Montpellier, , France
CHRU de Montpellier - Service de Médecine Interne
Montpellier, , France
CHU de Montpellier - Service d'hématologie Oncologie
Montpellier, , France
CHU Nantes - Hôtel Dieu
Nantes, , France
Centre Catherine de Sienne
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Archet 1
Nice, , France
CHU de Nîmes
Nîmes, , France
CHR d'Orléans
Orléans, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Saint Antoine - Service de Médecine Interne
Paris, , France
Hôpital de La Pitié-Salpêtrière
Paris, , France
Hôpital Saint Antoine - Service d'Hématologie Clinique
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Necker
Paris, , France
Centre Hospitalier Joffre
Perpignan, , France
CHU de Haut-Lévèque
Pessac, , France
Centre Hospitalier Lyon-Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
Centre Hospitalier Annecy Genevois
Pringy, , France
CHU de Reims
Reims, , France
Hôpital PONTCHAILLOU
Rennes, , France
Centre Hospitalier de Rochefort
Rochefort, , France
Centrer Hospitalier de Roubaix
Roubaix, , France
Centre Henri Becquerel
Rouen, , France
CH Yves Le Foll
Saint-Brieuc, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
IUCT Oncopole
Toulouse, , France
Hôpital Bretonneau
Tours, , France
Centre Hospitalier de Troyes
Troyes, , France
CH Valence
Valence, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Countries
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References
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Boy M, Bisio V, Zhao LP, Guidez F, Schell B, Lereclus E, Henry G, Villemonteix J, Rodrigues-Lima F, Gagne K, Retiere C, Larcher L, Kim R, Clappier E, Sebert M, Mekinian A, Fain O, Caignard A, Espeli M, Balabanian K, Toubert A, Fenaux P, Ades L, Dulphy N. Myelodysplastic Syndrome associated TET2 mutations affect NK cell function and genome methylation. Nat Commun. 2023 Feb 3;14(1):588. doi: 10.1038/s41467-023-36193-w.
Other Identifiers
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2016-000918-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GFM-AZA-SAID
Identifier Type: -
Identifier Source: org_study_id
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