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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01305135
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Groupe Francophone des Myelodysplasies

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

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).

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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


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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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
Show Show 32 study locations
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
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Principal Investigator: Lionel ADES, PHD,MD GFM: Groupe Francophone des Myélodysplasies
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Responsible Party: Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier: NCT01305135    
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:
myelodysplastic syndrome, azacitidine, idarubicin
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
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