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Clinical Trials/EUCTR2005-000550-75-GB
EUCTR2005-000550-75-GB
Active, not recruiting
Phase 1

Phase II Study of the Tolerability and Efficacy of the Histone Deacetylase Inhibitor Sodium Valproate given in Conjunction with 5-azacytidine and ATRA (all trans retinoic acid ) in Patients with Acute Myeloid Leukaemia. - Val/Aza

niversity of Birmingham0 sites80 target enrollmentJanuary 31, 2006
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DrugsVidazaEpilim 500 Enteric Coated: Epilim 200 Enteric coatedVesinoidNuelin

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Birmingham
Enrollment
80
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2006
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\) Satisfy WHO criteria for diagnosis of AML or high risk MDS
  • •2\) Relapsed/refractory AML/high risk MDS
  • •3\) de novo AML aged over 70
  • •4\) High risk MDS/AML in whom intensive chemotherapy is not clinically indicated
  • •5\) Age equal or greater than 18 years
  • •6\) WHO performance status 0,1,2
  • •7\) Able to swallow capsules
  • •8\) At least 2 weeks from previous chemotherapy
  • •9\) Men and women to practive effective contraception
  • •10\) Women of child bearing potential must have a negative pregnancy test

Exclusion Criteria

  • •1\) Patients with contraindications to receiving sodium valproate, ATRA or 5\-azacitidine will be excluded
  • •2\) Patients who are high medical risks because of non\-malignant systemic disease and those with active uncontrolled infection
  • •3\) Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the trial
  • •4\) Pregnant or lactating women
  • •5\) Patients known to be serologically positive for Hepatitis B, C or HIV
  • •6\) Concurrent congestive heart failure or prior history of New York Heart Association Class III/IV cardiac disease

Outcomes

Primary Outcomes

Not specified

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