Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes
NCT ID: NCT01305135
Last Updated: 2017-06-07
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
PHASE1/PHASE2
41 participants
INTERVENTIONAL
2010-12-30
2016-05-09
Brief Summary
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For the Phase I study :
Determine the safety and tolerance of escalating doses of Idarubicin combined to Azacitidine in patients with INT-2 or higher risk MDS.
For the phase II study:
Primary: Evaluate rate and duration of response (according to IWG 2006 criteria and IWG 2000 criteria) to the combination of Idarubicin and Azacitidine in patients with INT-2 or higher risk MDS
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Detailed Description
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* The first 10 patients will receive Idarubicin 5 mg/m2/d on day 8 of each cycle of Azacitidine 75 mg/m2/d CI during 7 days (First Cohort ).
* Progression or not to the next cohort of 10 patients : Idarubicin 10 mgm2/d on day 8 of each cycle of Azacitidine 75 mg/m2/d CI during 7 days (Second cohort of 10 patients), will be decided after completion of the first cohort, after review of hematological toxicity by an independent safety review committee (SRC).
* The next 21 patients will be treated either according to the first or second cohort schedule of Idarubicin, after review of hematological toxicity and efficacy by an independent safety review committee (SRC).
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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azacitidine 75mg/m²/d + idarubicin 5mg/m²/d
phase I : palier 1 have 10 patients and palier 2 have to 10 patients.
palier 1: Ida 5mg/m²/d (D8) + AZACITIDINE 75mg/m²/d (D1-D7)
azacitidine and idarubicin
azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8
Azacitidine 75mg/m²/d + idarubicin 10mg/m²/d
palier 2: Ida 10mg/m²/d (D8)+ Azacitidine 75mg/m²/d (D1-D7)
azacitidine and idarubicin
azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8
Interventions
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azacitidine and idarubicin
azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8
Eligibility Criteria
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Inclusion Criteria
* IPSS score ≥1.5
* Myocardial function do not contraindicate the use of idarubicin
* Age ≥ 18 years
* Performance Status ≤2 according to ECOG.
* Serum creatinine \< 1.5 x ULN and normal levels of electrolytes (serum sodium 136-145 mmol/l, Potassium 3,5-4,5 mmol/l, alkaline Reserve 23-29 mmol/l, , Calcium 2,15-2,5 mmol/l, Phosphore 0,87-1,45 mmol/l) Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \< 1.5 x upper limit of normal (ULN)
* Serum total bilirubin \< 1.5 x ULN.
* Must be able to adhere to the study visit schedule and other protocol requirements
* Signed informed consent.
Female subjects of childbearing potential must:
• Accept effective contraception without interruption throughout the duration of study and up to three months after the end of treatment.
Male subjects must
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy and up to three months after the final treatment if their partner is of childbearing potential and has no contraception.
* Agree to learn the procedures for preservation of sperm
Exclusion Criteria
* Prior therapy with anthracycline for MDS.
* Eligible for an allogeneic stem cell transplantation.
* Prior therapy with demethylating agents within the last 3 months
* Prior therapy with Hematopoietic growth factor (ESA or G-CSF) agents or cytotoxic agents (oral chemotherapy, low doses AraC) within the last 30 days.
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast)
* Pregnant or lactating females
* Known HIV-1 positivity
* Contra-indication to Anthracyclines
18 Years
ALL
No
Sponsors
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Groupe Francophone des Myelodysplasies
OTHER
Responsible Party
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Principal Investigators
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Lionel ADES, PHD,MD
Role: PRINCIPAL_INVESTIGATOR
GFM: Groupe Francophone des Myélodysplasies
Locations
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CHU de Haut-Lévèque
Pessac, Bordeaux - Pessac, France
CHU d'Amiens
Amiens, , France
CHU d'Angers
Angers, , France
Hôpital de la cote basque
Bayonne, , France
Hôpital Avicenne
Bobigny, , France
CHRU de Caen - Hôpital Côte de Nacre
Caen, , France
CHU Estaing
Clermont-Ferrand, , France
CHU Dijon Hôpital d'enfants
Dijon, , France
CHU Albert Michallon
Grenoble, , France
CH Le Mans
Le Mans, , France
CHU de Limoges
Limoges, , France
Centre Hospitalier Lyon Sud
Lyon, , France
Institut Paoli-Calmette
Marseille, , France
CHU Brabois
Nancy, , France
CHU Hotel dieu
Nantes, , France
CHU NICE, Hôpital l'Archet
Nice, , France
Hôpital saint louis - Hématologie Clinique
Paris, , France
Hôpital Saint Louis - Hématologie Séniors
Paris, , France
Hôpital Saint Antoine
Paris, , France
Hôpital cochin
Paris, , France
Centre hospitalier Joffre
Perpignan, , France
CH de Périgueux
Périgueux, , France
CHU de Poitiers
Poitiers, , France
Hôpital Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Hôpital Hautepierre
Strasbourg, , France
Hôpital PURPAN - Hématologie Clinique
Toulouse, , France
Hôpital Purpan - Médecine Interne
Toulouse, , France
Hôpital Bretonneau
Tours, , France
CH de Valence
Valence, , France
Institut Gustave Roussy
Villejuif, , France
Hôpital Aziza Othmana
Tunis, , Tunisia
Countries
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Other Identifiers
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GFM-AZA-IDA-09
Identifier Type: -
Identifier Source: org_study_id
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