A study to evaluate the efficacy and safety of combination chemotherapy of panobinostat and decitabine, given after donor stem cell transplantation in patients with (very) poor risk AM

• Conditions: (very) poor risk AML or RAEB with IPSS = 1.5; MedDRA version: 18.0Level: LLTClassification code 10024329Term: LeukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-003344-74-BE
• Lead Sponsor: HOVON Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with poor risk or very poor risk AML or RAEB with IPSS = 1.5.
• Eligibility for continuation with intensive induction/consolidation chemotherapy
• Eligible for allogeneic donor search (related/unrelated)
• 18-70 years, inclusive
• Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma in situ” of the cervix or breast
• Known HIV-positivity
• Pregnant or breast-feeding female patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified