5-Azacitidine in Low-risk Myelodysplastic Syndromes (MDSs) (MDSAZA0706)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Udine
University of Bologna
University of Genova
University of Siena
Cremona
Mantova
Information provided by (Responsible Party):
Domenico Russo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT00897130
First received: May 8, 2009
Last updated: April 5, 2013
Last verified: April 2013
  Purpose

Azacitidine will be given at a dose of 75 mg/sqm (s.c) daily for 5 consecutive days every 28 days (every month) for a total of 8 courses to low risk MDSs according to IPSS scoring system. In fact, several studies produced high rates of trilineage responses, reduces the risk of progression to acute myeloid leukemia (AML) in high-risk MDS and improves the quality of life (QoL). The use of 5-Aza in the earlier phases of MDS could reduce the proliferative advantage of MDS clone and favour the regrowth of normal hematopoiesis.


Condition Intervention Phase
Myelodysplastic Syndrome
Drug: Azacytidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical and Biological Effects of 5-Azacitidine Five Days/Monthly Schedule in Symptomatic Low-risk Myelodysplastic Syndromes (MDSs)

Resource links provided by NLM:


Further study details as provided by Università degli Studi di Brescia:

Primary Outcome Measures:
  • To evaluate the efficacy (hematologic response) of five days monthly 5-Aza treatment schedule in patients with low-risk MDS (IPSS 0-1). [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To evaluate the toxicity of five days monthly 5-Aza treatment schedule in patients with low-risk MDS (IPSS 0-1). [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the QoL by the FACT-An questionnaire [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: August 2008
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacytidine
Azacitidine will be given at a dose of 75mg/sqm subcutaneous daily for 5 consecutive days every 28 days (every month) for a total of 8 courses. 5-Aza dosages will be adjusted.
Drug: Azacytidine
Azacitidine will be given at a dose of 75mg/sqm subcutaneous daily for 5 consecutive days every 28 days (every month) for a total of 8 courses. 5-Aza dosages will be adjusted
Other Name: Azacytidine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with low-risk (IPSS 0-INT1) MDS according to WHO classification, presenting one or more of the followings:

    • Symptomatic anemia requiring RBC transfusion supportive therapy previously unresponsive to EPO or not expected to respond to EPO
    • Thrombocytopenia requiring platelet transfusion with or without muco-cutaneous haemorrhagic syndrome
    • Persistent (> 3 months) absolute neutrophil count less then 1,5 x 109/L, with or without infections, requiring or not myeloid growth factor therapy
  • ≥ 18 years old.
  • Life expectancy ≥ 3 months.
  • ECOG performance Status Grade 0-2.
  • Serum bilirubin levels ≤ 1.5 upper limit of the normal (ULN)
  • Serum GOT and GPT levels ≤ 2x UNL.
  • Creatinine levels ≤ 1.5x UNL.
  • Negative serum β-human chorionic gonadotropin (β-HCG) pregnancy test 24 hours prior to beginning of therapy with 5-AZA, for fertile women.
  • Written informed consent.

Exclusion Criteria:

  • Patients with MDS according to WHO classification with INT-2 or high IPSS risk.
  • Life expectancy < 3 months.
  • ECOG performance Status Grade > 2.
  • Serum bilirubin levels >1.5 upper limit of the normal (ULN).
  • Serum GOT and GPT levels > 2 x UNL.
  • Creatinine levels >1.5 x UNL.
  • Pregnancy or breast feeding.
  • Insulin-dependent diabetes and uncontrolled non insulin-dependent diabetes.
  • Severe cardiac or pulmonary disease incompatible with the conduction of the protocol.
  • Patient with a clear indication to receive long-term anticoagulant therapy.
  • Other active hematologic or solid tumors.
  • Severe CNS disease.
  • Malignant hepatic tumors.
  • Hypersensitivity to mannitol or azacitidine.
  • No written informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897130

Locations
Italy
University of Bologna
Bologna, Italy
Chair of Haematology, Bone Marrow Transplant Unit
Brescia, Italy, 25123
Cremona
Cremona, Italy
University of Genova
Genova, Italy
Mantova
Mantova, Italy
University of Siena
Siena, Italy
University of Udine
Udine, Italy
Sponsors and Collaborators
Università degli Studi di Brescia
University of Udine
University of Bologna
University of Genova
University of Siena
Cremona
Mantova
Investigators
Principal Investigator: Prof Domenico Russo, MD Chair of Haematology, Brescia University
  More Information

Publications:
Responsible Party: Domenico Russo, Full Professor of Hematology, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT00897130     History of Changes
Other Study ID Numbers: 2007-003943-55
Study First Received: May 8, 2009
Last Updated: April 5, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Università degli Studi di Brescia:
low-risk (IPSS 0-INT1) MDS according to WHO classification

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014