Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01356875
Status:
UNKNOWN
Last Update Posted:
2011-05-20
First Post:
2011-05-18
Brief Title:
Treatment of Myelodysplastic Syndromes Comparing HydralazineAc Valproic and Supportive Care in Patients Not Candidates Refractory andor Intolerant to Intensive Chemotherapy
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Phase II Clinical Trial for Treatment of Myelodysplastic Syndromes Comparing Hydralazine AcValproico and Supportive Care in Patients Not Candidates Refractory and or Intolerant to Intensive Chemotherapy
Status:
UNKNOWN
Status Verified Date:
2011-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transfusional dependence has been associated closely and independently with low survival in patients with myelodysplastic syndrome MDS especially in patients at low risk according to IPSS Treatment of patients with hydralazine valproic acid as an alternative to treatment with 5-azacytidine has lower cost and possibly as effective with fewer side effects The objective of this phase II study is to determine the effectiveness of combination therapy with hydralazine Ac Valproic compared with best supportive care The investigators will select 42 patients per group and after 14 weeks of treatment the investigators will study in both groups the hematological response transfusion-dependent hemoglobin cytogenetics and morphology and treatment safety adverse reactions and vital signs to 1 year after starting treatment The concentration of hemoglobin the number of transfusions platelets neutrophils and other continuous variables in both groups will be compared by Student t or Mann-Whitney as appropriate For comparison of cytogenetic and morphological response and other categorical variables between groups Chi square will be used And within each group the investigators will compare each of these variables before and after treatment by t-test for paired data or Wilcoxon test
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None