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

NCT ID: NCT01356875

Last Updated: 2011-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-01-31

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.

Conditions

Myelodysplastic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 cycles of hydralazine and valproic acid.

Group Type: EXPERIMENTAL

HIDRA/VPA

Intervention Type: DRUG

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.

best supportive care (BSC)

The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.

Group Type: ACTIVE_COMPARATOR

BSC

Intervention Type: DRUG

The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.

Interventions

BSC

The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Osakidetza/Basque Health Service

Locations

Txagorritxu Hospital

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

Central Contacts

Breno Moreno de Gusmao, MD

Role: CONTACT

breno.morenodegusmao@osakidetza.net

+34-945 007000

Facility Contacts

Breno Moreno de Gusmao, MD

Role: primary

breno.morenodegusmao@osakidetza.net

+34 945 007000

Other Identifiers

SMD-TXAGO

Identifier Type: -

Identifier Source: org_study_id