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Efficacy and Tolerability of the Combination of Valproic Acid and Lenalidomide in the Treatment of Patients With Myelodysplastic Syndrome

NCT00977132 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-03-18

No results posted yet for this study

Summary

As part of a palliative therapy concept, feasibility, toxicity, and effectiveness of treatment with the combination of Valproic acid and lenalidomide in Myelodysplastic Syndrome patients with a favorable risk profile will be investigated.

Conditions

  • Myelodysplastic Syndrome MDS

Interventions

DRUG

Valproic aicd

Treatment with VPA starts at day1, the dose ist slowly increase according to the following scheme day morning dose midday dose evening dose contents of 1 tablet 1+2 0 0 1 500 mg 3+4 ½ 0 1 500 mg 5+6 1 0 1 500 mg 7+8 1 ½ 1 500 mg 9+10 1 1 1 500 mg 11+12 1 1 1 500 mg In the morning of day 13 trough level of VPA will be checked. The target range will be 50-110 µg/l. The dose of VPA will be adjusted depending on the trough level. In the first eight weeks of therapy weekly controls of VPA levels are required. Thereafter, VPA levels will be checked every four weeks.

DRUG

Lenalidomide

5 mg/day, continuous therapy Dosing will be in the morning at approximately the same time each day. Capsules may be taken before or after a meal. Only one cycle of study drug (28 days) will be supplied to the patient every four weeks

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Norbert Gattermann, Professor · Department of Hematology, Oncology and Clinical Immunology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-05-31
Completion
2014-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00977132 on ClinicalTrials.gov