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Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT01305135
First received: February 25, 2011
Last updated: June 6, 2017
Last verified: June 2017
  Purpose

Patients will receive escalating doses of ldarubicin combined to Azacitidine given at the FDA/EMEA approved Schedule and dosing.

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


Condition Intervention Phase
High Grade Myelodysplastic Syndrome Lesions Drug: azacitidine and idarubicin Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Study of the Efficacy and Safety of Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes

Resource links provided by NLM:


Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • To determined tolerance and dose limiting toxicities to idarubicin and azacitidine association. [ Time Frame: After 12 weeks treatment ]

Secondary Outcome Measures:
  • to determined overall response rate and response duration [ Time Frame: After six months ]

Enrollment: 41
Actual Study Start Date: December 30, 2010
Study Completion Date: May 9, 2016
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)

Drug: 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
Experimental: Azacitidine 75mg/m²/d + idarubicin 10mg/m²/d
palier 2: Ida 10mg/m²/d (D8)+ Azacitidine 75mg/m²/d (D1-D7)
Drug: 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

Detailed Description:

Patients will receive ldarubicin combined to Azacitidine.

  • 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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented diagnosis of MDS, or CMML with WBC < 13,000/mm3 that meets IPSS criteria for intermediate-2 or high-risk disease,
  • 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:

  • Uncontrolled infection
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305135

Locations
France
CHU de Haut-Lévèque
Pessac, Bordeaux - Pessac, France, 33604
CHU d'Amiens
Amiens, France, 80054
CHU d'Angers
Angers, France, 49033
Hôpital de la cote basque
Bayonne, France, 64100
Hôpital Avicenne
Bobigny, France, 93009
CHRU de Caen - Hôpital Côte de Nacre
Caen, France, 14033
CHU Estaing
Clermont-Ferrand, France, 63000
CHU Dijon Hôpital d'enfants
Dijon, France, 21000
CHU Albert Michallon
Grenoble, France, 38043
CH Le Mans
Le Mans, France, 72000
CHU de Limoges
Limoges, France, 87042
Centre Hospitalier Lyon Sud
Lyon, France, 69495
Institut Paoli-Calmette
Marseille, France, 13009
CHU Brabois
Nancy, France, 54511
CHU Hotel dieu
Nantes, France, 44093
CHU NICE, Hôpital l'Archet
Nice, France, 06202
Hôpital saint louis - Hématologie Clinique
Paris, France, 75010
Hôpital Saint Louis - Hématologie Séniors
Paris, France, 75010
Hôpital Saint Antoine
Paris, France, 75012
Hôpital cochin
Paris, France, 75014
Centre hospitalier Joffre
Perpignan, France, 66046
CHU de Poitiers
Poitiers, France, 86021
CH de Périgueux
Périgueux, France, 24019
Hôpital Pontchaillou
Rennes, France, 35033
Centre Henri Becquerel
Rouen, France, 76038
Hôpital Hautepierre
Strasbourg, France, 67098
Hôpital PURPAN - Hématologie Clinique
Toulouse, France, 31059
Hôpital Purpan - Médecine Interne
Toulouse, France, 31059
Hôpital Bretonneau
Tours, France, 37000
CH de Valence
Valence, France, 26953
Institut Gustave Roussy
Villejuif, France, 94805
Tunisia
Hôpital Aziza Othmana
Tunis, Tunisia
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Principal Investigator: Lionel ADES, PHD,MD GFM: Groupe Francophone des Myélodysplasies
  More Information

Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT01305135     History of Changes
Other Study ID Numbers: GFM-AZA-IDA-09
Study First Received: February 25, 2011
Last Updated: June 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Groupe Francophone des Myelodysplasies:
myelodysplastic syndrome, azacitidine, idarubicin

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 23, 2017