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Idarubicin Combined to Azacitidine in Int-2 or High 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: High Grade Myelodysplastic Syndrome Lesions

Intervention: azacitidine and idarubicin (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Groupe Francophone des Myelodysplasies

Official(s) and/or principal investigator(s):
Lionel ADES, PHD,MD, Principal Investigator, Affiliation: GFM: Groupe Francophone des Myélodysplasies

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determined tolerance and dose limiting toxicities to idarubicin and azacitidine association.

Secondary outcome: to determined overall response rate and response duration

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

CHU d'Amiens, Amiens 80054, France

CHU d'Angers, Angers 49033, France

Hôpital de la cote basque, Bayonne 64100, France

Hôpital Avicenne, Bobigny 93009, France

CHU de Haut-Lévèque, Bordeaux Pessac 33604, France

CHU Estaing, Clermont-Ferrand 63000, France

CHU Dijon Hôpital d'enfants, Dijon 21000, France

CH Le Mans, Le Mans 72000, France

Centre Hospitalier Lyon Sud, Lyon 69495, France

CHU Brabois, Nancy 54511, France

CHU Hote dieu, Nantes 44093, France

Hôpital cochin, Paris 75014, France

Hôpital Saint Antoine, Paris 75012, France

Hôpital saint louis, Paris 75010, France

Centre hospitalier Joffre, Perpignan 66046, France

CHU de Poitiers, Poitiers 86021, France

CH de Périgueux, Périgueux 24019, France

Hôpital Pontchaillou, Rennes 35033, France

Hôpital Hautepierre, Strasbourg 67098, France

Hôpital Purpan, Toulouse 31059, France

Hôpital Bretonneau, Tours 37000, France

CH de Valence, Valence 26953, France

Institut Gustave Roussy, Villejuif 94805, France

Hôpital Aziza Othmana, Tunis, Tunisia

Service des maladies du sang, CHU d'Angers, Angers 49033, France

Service d'Hématologie Clinique, CHRU Clemenceau, Caen 14033, France

Service d'Hématologie Clinique, CHU Albert Michallon, Grenoble 38043, France

Service d'Hématologie Clinique, CHU de Limoges, Limoges 87042, France

Département d'hématologie, Institut Paoli-Calmette, Marseille 13009, France

Service d'Hématologie Clinique, CHU NICE, Hôpital l'Archet, Nice 06202, France

Département d'hématologie, Centre Henri Becquerel, Rouen 76038, France

Service d'Hématologie Clinique, Hôpital PURPAN, Toulouse 31059, France

Additional Information

Starting date: December 2010
Last updated: April 23, 2015

Page last updated: August 23, 2015

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