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A open label, phase 2, non randomized, multicentre trial to assess the feasibility of induction treatment with 5-azacitidine (5-AZA) followed by allogeneic stem cell transplantation (allo-SCT) or continued 5-AZA treatment in patients without a suitable -sibling or unrelated- stem cell donor with IPSS Int-2/High risk myelodysplastic syndromes (MDS) - BMT-AZA

A open label, phase 2, non randomized, multicentre trial to assess the feasibility of induction treatment with 5-azacitidine (5-AZA) followed by allogeneic stem cell transplantation (allo-SCT) or continued 5-AZA treatment in patients without a suitable -sibling or unrelated- stem cell donor with IPSS Int-2/High risk myelodysplastic syndromes (MDS) - BMT-AZA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019673-15-IT
Enrollment
Unknown
Registered
2010-07-20
Start date
2010-07-15
Completion date
Unknown
Last updated
2016-04-11

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

Conditions

myelodysplastic syndrome (MDS) MedDRA version: 9.1 Level: LLT Classification code 10028533

Interventions

Trade Name: VIDAZA Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: AZACITIDINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-

Sponsors

Universit? Cattolica del Sacro Cuore
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Have a diagnosis of myelodysplastic syndrome (MDS) according to the WHO classification for MDS (Appendix F) with a intermediate-2 or high IPSS score (score = 1.5, Appendix G) or a diagnosis of CMMoL according to the FAB classification (appendix B) with 10-20% BM or PB blasts and WBC =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - acute myeloid leukaemia; - concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma); - severe renal impairment (creatinine clearance 2 x ULN and total bilirubin >1.5 x ULN (unless due to active hemolysis or ineffective erythropoiesis; - HIV infection; - active, uncontrolled HCV or HBV infections or liver cirrhosis; - clinically relevant neurological diseases; - psychiatric illness that would prevent granting of informed consent; - hypersensitivity (known or suspected) to Azacitidine or Mannitol; - prior Treatments: Prior investigational drugs (within 30 days) Radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months Growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days Androgenic hormones during the previous 14 days Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the feasibility of allo-BMT after 5-azacitidine as first line therapy before allotransplant.;Primary end point(s): • the rate of enrolled patients suitable to BMT and currently performing BMT after 5-azacitidine.;Secondary Objective: • Efficacy and safety of 5-AZA in patients not receiving HSCT for any reasons • Overall response rate (ORR) to 5-azacitidine • Overall Survival (OS) at 1 year • Disease Free Survival (DFS) at 1 year • Transplant related Mortality (TRM) at 1 year after transplantation • Time to progression of MDS • Time to progression to AML • Rate of hematopoietic engraftment—

Countries

Italy

Outcome results

None listed

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