Phase II study of combination therapy with 5-AZAcytidine, Valproic acid, and All-Trans Retinoic Acid in patients with myelodysplastic syndromes and other myeloid malignancies who cannot receive intensive chemotherapy

Phase 2

Completed

• Conditions: Myelodysplastic syndromes (MDS); Cancer; Neoplasms

• Registration Number: ISRCTN92868457
• Lead Sponsor: Heinrich-Heine-University (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-19
• Study Completion: 2010-05-01
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Primary Myelodysplastic Syndromes (pMDS) with unfavourable risk profile (more than 10% blast cells in the bone marrow, unfavourable karyotype)
2. Therapy-related (secondary) Myelodysplastic Syndromes (sMDS)
3. Chronic Myelomonocytic Leukaemia (CMML)
4. De-novo or secondary acute myeloid leukemia in elderly patients who cannot be treated with intensive chemotherapy

Exclusion Criteria

1. Impaired liver or kidney function
2. Pregnancy
3. Simultaneous participation in another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety/toxicity, assessed at one year after treatment start.

Secondary Outcome Measures

Name	Time	Method
<br> All endpoints will be assessed at one year after treatment start:<br> 1. Haematological response<br> 2. Progression-free survival<br> 3. Overall survival<br>