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PhII 5-Azacytidine Plus Valproic Acid and Eventually Atra in Intermediate II and High Risk MDS

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ClinicalTrials.gov Identifier: NCT00439673
Recruitment Status : Completed
First Posted : February 26, 2007
Results First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:

The primary objective of the trial is to assess the activity of the combined use of Valproic Acid (VPA)in combination with 5-Azacytidine (5-Aza C) in the treatment of MDS.

Activity will be evaluated as percentage of patients achieving complete or partial remission.


Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: 5-Azacytidine Drug: Valproic Acid Drug: ATRA Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Open Label, Phase II, Non Randomized, Clinical Trial of Chemotherapy Treatment With 5-Azacytidine Plus Valproic Acid and Eventually Atra for Patients Diagnosed With Intermediate II and High Risk Myelodysplastic Syndrome (MDS). EudraCT Number 2005-004811-31. GIMEMA Protocol MDS0205
Study Start Date : May 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010





Primary Outcome Measures :
  1. The Primary Objective of the Trial is to Assess the Efficacy of the Combined Use of Valproic Acid (VPA) in Combination With 5-Azacytidine (5-Aza C) in the Treatment of MDS. [ Time Frame: At 60 months ]
    Overall survival


Secondary Outcome Measures :
  1. Time to Transformation to AML [ Time Frame: At 60 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:

  • Have a diagnosis of refractory anemia with excess blasts (RAEB) or refractory anemia with excess blasts in transformation (RAEB-t) according to the French-American-British classification system for MDS with an International Prognostic Scoring System score of INT-2 or High or diagnosis of Myelodysplastic CMMoL per a modified FAB criteria and a relatively high risk of AML transformation;

    • Age ≥18 years;
    • life expectancy ≥3 months;
    • Be unlikely to proceed to bone marrow or stem cell transplantation therapy following remission;
    • Signed written informed consent according to IGH/EU/GCP and national local laws;
    • Eastern Cooperative Oncology Group Performance Status Grade of 0-2 (Appendix D);
    • Serum bilirubin levels ≤1.5 x the upper limit of the normal (ULN) range for the laboratory; higher levels are acceptable if these can be attributed to active hemolysis (as indicated by positive direct Coombs' testing, decreased haptoglobin level, elevated indirect bilirubin and/or lactate dehydrogenase), or ineffective erythropoiesis (as indicated by bone marrow findings);
    • Serum glutamic-oxaloacetic transaminase (aspartate aminotransferase) or serum glutamic-pyruvic transaminase (alanine aminotransferase) levels ≤2 x ULN;
    • Women of childbearing potential may participate, providing they meet the following conditions:
  • Must not start a pregnancy throughout the study and for 6 months following the date of the last dose of study medications;
  • Must have a negative serum pregnancy test obtained within 48 hours prior to Day 1.

    • Males with female partner of childbearing potential must avoid fathering throughout the study and for 6 months following the date of the last dose of study medication.

Exclusion criteria:

  • acute myeloid leukaemia (i.e. bone marrow blasts >30%);
  • concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);
  • severe renal impairment (creatinine clearance <30 ml/min);
  • pregnant or lactating, or are potentially fertile (both males and females) and have not agreed to avoid pregnancy during the trial period;
  • they have liver disease characterized by AST and ALT level >2X ULN and total bilirubin > 1.5X 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 Azacytidine or Mannitol
  • prior Treatments: Prior investigational drugs (within 30 days) Radiation therapy, 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.

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): NCT00439673


Locations
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Italy
USL 8 di Arezzo
Arezzo, Italy
Azienda Ospedaliera S. G. Moscati
Avellino, Italy
Università degli studi di Bari
Bari, Italy
Istituto ematologia e oncologia medica L.A. Seragnoli
Bologna, Italy
Ospedale Reg. A di Summa
Brindisi, Italy
Ospedale A. Businco
Cagliari, Italy
Università degli studi di Roma La Cattolica
Roma, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Giuseppe LEONE, MD, PHD Università degli studi di Roma La Cattolica

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT00439673     History of Changes
Other Study ID Numbers: MDS0205
First Posted: February 26, 2007    Key Record Dates
Results First Posted: August 7, 2018
Last Update Posted: August 7, 2018
Last Verified: August 2018

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
MDS
5-Azacytidine
valproic acid
atra
intermediate or high risk
Age ≥18 yearsAge

Additional relevant MeSH terms:
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Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Valproic Acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs