High Grade Myelodysplastic Syndrome Lesions Clinical Trial
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
| Verified date | June 2017 |
| Source | Groupe Francophone des Myelodysplasies |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | May 9, 2016 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 cochin | Paris | |
| France | Hôpital Saint Antoine | Paris | |
| France | Hôpital saint louis - Hématologie Clinique | Paris | |
| France | Hôpital Saint Louis - Hématologie Séniors | Paris | |
| France | CH de Périgueux | Périgueux | |
| France | Centre hospitalier Joffre | Perpignan | |
| France | CHU de Haut-Lévèque | Pessac | Bordeaux - Pessac |
| 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 | |
| Tunisia | Hôpital Aziza Othmana | Tunis |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe Francophone des Myelodysplasies |
France, Tunisia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determined tolerance and dose limiting toxicities to idarubicin and azacitidine association. | After 12 weeks treatment | ||
| Secondary | to determined overall response rate and response duration | After six months |