A phase I-II study of the efficacy and safety of Idarubicin combined to Azacitidine in int-2 or high risk myelodysplastic syndromes - GFM- Aza-Ida-09

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-017178-19-FR

Enrollment

Registered

2010-07-15

Start date

2010-09-14

Completion date

Unknown

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndromes MedDRA version: 12.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome

Interventions

Trade Name: ZAVEDOS® Pharmaceutical Form: Suspension for injection Trade Name: Azacitidine (Vidaza®) Product Name: Azacitidine (Vidaza®) Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Documented diagnosis of MDS, or CMML with WBC =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Uncontrolled infection -Prior therapy with anthracycline for MDS. -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

Design outcomes

Primary

Measure	Time frame
Main Objective: For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicine combined to Azacitidine in patients with INT-2 or Highr 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 Idarubicine and Azacytidine in patients with INT-2 or Highr risk MDS. ;Secondary Objective: Secondary: - the safety (particularly hematological toxicity) of the combination - duration of response, - progression to AML, - survival. - the rate of hematological improvement ;Primary end point(s): For Phase I: tolerance of two dose levels of idarubicin associated with azacitidine. It will be analyzed after 2 cycles, For Phase II: number of complete responses (CR) + partial response (PR) + RC marrow by IWG 2006 criteria after 3 and 6 cycles of treatment.	—

Measure

Time frame

Main Objective: For the Phase I study : Determine the safety and tolerance of escalating doses of Idarubicine combined to Azacitidine in patients with INT-2 or Highr 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 Idarubicine and Azacytidine in patients with INT-2 or Highr risk MDS. ;Secondary Objective: Secondary: - the safety (particularly hematological toxicity) of the combination - duration of response, - progression to AML, - survival. - the rate of hematological improvement ;Primary end point(s): For Phase I: tolerance of two dose levels of idarubicin associated with azacitidine. It will be analyzed after 2 cycles, For Phase II: number of complete responses (CR) + partial response (PR) + RC marrow by IWG 2006 criteria after 3 and 6 cycles of treatment.

—

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026