Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy

Myelodysplastic Syndrome Clinical Trial

Official title:

Phase II Clinical Trial for Treatment of Myelodysplastic Syndromes Comparing Hydralazine / Ac.Valproico and Supportive Care in Patients Not Candidates, Refractory and / or Intolerant to Intensive Chemotherapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01356875
• Other study ID #: SMD-TXAGO
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 18, 2011
• Last updated: May 19, 2011
• Start date: September 2011
• Est. completion date: January 2015

Study information

• Verified date: April 2011
• Source: Basque Health Service
• Contact: Breno Moreno de Gusmao, MD
• Phone: +34-945 007000
• Email: breno.morenodegusmao[@]osakidetza.net
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to understand and voluntarily sign the consent form.

2. Age = 18 years at the time of signing the informed consent form.

3. Ability and willingness to meet the schedule of study visits and other protocol requirements.

4. Documented diagnosis of SMDs according to the criteria of disease risk IPSS intermediate-2, high risk or any risk with transfusion requirements.

5. Transfusion-dependent anemia erythrocytes defined as the absence of a period of 56 consecutive days without transfusion of red blood cells for at least 112 days prior (16 weeks).

6. Engage both women and men to use highly effective contraception.

7. Patients are not candidates for treatment with azacitidine or chemotherapy

Exclusion Criteria:

• Patients who have any of these exclusion criteria may not be included in the trial:

1. Pregnant or breastfeeding.

2. After hematopoietic stem cell transplantation.

3. Patients with vitamin B12 deficiency, Folic Acid and Iron

4. Any severe psychiatric illness or condition that prevents the patient sign the consent form for the patient or involves an unacceptable risk in case of participating in the study.

5. Hypersensitivity to hydralazine and / or AC. Valproic

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• BSC
The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.
• HIDRA/VPA
In each cycle (30 days), Hydralazine 50mg tablets every 12 hours and Valproic 500mg tablets every 8 hours will be administrated orally to HYDRA / VPA group.Each patient will receive 6 cycle.

Locations

Country	Name	City	State
Spain	Txagorritxu Hospital	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hemoglobin from baseline in patients who express an erythroid response.	Independence RBC transfusion requirement for = 8 weeks (56 days) followed by treatment at any time.	8 weeks	No
Secondary	Erythroid response according to the criteria of the international working group of SMDs at 24 weeks	Number and type of administered blood transfusions, time between the last transfusion prior to inclusion in the study and the first transfusion after the 8 weeks of treatment.	24 weeks	No