Treatment of Myelodysplastic Syndromes Comparing Hydralazine/Ac. Valproic and Supportive Care in Patients Not Candidates, Refractory and/or Intolerant to Intensive Chemotherapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myelodysplastic Syndrome |
Drug: BSC Drug: HIDRA/VPA |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- change in hemoglobin from baseline in patients who express an erythroid response. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Independence RBC transfusion requirement for ≥ 8 weeks (56 days) followed by treatment at any time.
- Erythroid response according to the criteria of the international working group of SMDs at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 42 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: best supportive care (BSC)
The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.
|
Drug: BSC
The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ability to understand and voluntarily sign the consent form.
- Age ≥ 18 years at the time of signing the informed consent form.
- Ability and willingness to meet the schedule of study visits and other protocol requirements.
- Documented diagnosis of SMDs according to the criteria of disease risk IPSS intermediate-2, high risk or any risk with transfusion requirements.
- 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).
- Engage both women and men to use highly effective contraception.
- 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:
- Pregnant or breastfeeding.
- After hematopoietic stem cell transplantation.
- Patients with vitamin B12 deficiency, Folic Acid and Iron
- 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.
- Hypersensitivity to hydralazine and / or AC. Valproic
Contacts and Locations| Contact: Breno Moreno de Gusmao, MD | +34-945 007000 | breno.morenodegusmao@osakidetza.net |
| Spain | |
| Txagorritxu Hospital | Not yet recruiting |
| Vitoria-Gasteiz, Alava, Spain, 01009 | |
| Contact: Breno Moreno de Gusmao, MD +34 945 007000 breno.morenodegusmao@osakidetza.net | |
More Information
No publications provided
| Responsible Party: | Breno Moreno De Gusmao, Osakidetza/Basque Health Service |
| ClinicalTrials.gov Identifier: | NCT01356875 History of Changes |
| Other Study ID Numbers: | SMD-TXAGO |
| Study First Received: | May 18, 2011 |
| Last Updated: | May 19, 2011 |
| Health Authority: | Spain: Ethics Committee Spain: Spanish Agency of Medicines |
Keywords provided by Basque Health Service:
|
myelodysplastic syndrome Transfusion Hydralazine valproic acid |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Valproic Acid Hydralazine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Antihypertensive Agents Cardiovascular Agents Vasodilator Agents |
ClinicalTrials.gov processed this record on May 23, 2013