Trial record 3 of 255 for:
IDARUBICIN
Idarubicin Combined to Azacitidine in Int-2 or High Risk Myelodysplastic Syndromes
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| ClinicalTrials.gov Identifier: NCT01305135 |
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Recruitment Status :
Completed
First Posted : February 28, 2011
Last Update Posted : June 7, 2017
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Sponsor:
Groupe Francophone des Myelodysplasies
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies
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Brief 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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| High Grade Myelodysplastic Syndrome Lesions | Drug: azacitidine and idarubicin | Phase 1 Phase 2 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 41 participants |
| 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 |
| Actual Study Start Date : | December 30, 2010 |
| Actual Primary Completion Date : | June 2011 |
| Actual Study Completion Date : | May 9, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Myelodysplastic Syndromes
| Arm | Intervention/treatment |
|---|---|
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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 |
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Experimental: Azacitidine 75mg/m²/d + idarubicin 10mg/m²/d
palier 2: Ida 10mg/m²/d (D8)+ Azacitidine 75mg/m²/d (D1-D7)
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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 |
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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Groupe Francophone des Myelodysplasies |
| ClinicalTrials.gov Identifier: | NCT01305135 History of Changes |
| Other Study ID Numbers: |
GFM-AZA-IDA-09 |
| First Posted: | February 28, 2011 Key Record Dates |
| Last Update Posted: | June 7, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Groupe Francophone des Myelodysplasies:
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myelodysplastic syndrome, azacitidine, idarubicin |
Additional relevant MeSH terms:
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Idarubicin Syndrome Myelodysplastic Syndromes Preleukemia Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms |
Azacitidine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors |