Prospective, phase II randomized study to compare busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC regimen prior to allogeneic transplantation of hematopoietic cells for the treatment of myelofibrosis

Phase 1

• Conditions: Primary or secondary myelofibrosis after essential thrombocytemia or polycyhemia vera; MedDRA version: 14.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2010-022052-23-IT
• Lead Sponsor: GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-19
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age = 18 = 70 years • Primary or secondary myelofibrosis after essential thrombocytemia or polycyhemia vera • One of the following unfavourable prognostic factors: - Hb < 10 g/dL - Leukocytes >25x106/L - > 1% circulating blasts in the peripheral blood - constitutional symptoms • PS (Karnofsky)= 60% • HCT-CI = 5 • Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• = 20% blasts in the peripheral blood and/or in bone marrow • Positive serologic markers for human immunodeficiency virus (HIV) • Acute hepatitis B virus (HBV) or acute hepatis C virus (HCV) infection • Severe irreversible renal, hepatic , pulmonary or cardiac disease , such as: - total bilirubin, SGOT or SGPT > 5 the upper normal limit - Left ventricular ejection fraction < 30% - Clearance creatinine < 30 ml/min - DLCO < 30% and/or receiving supplementary oxygen • Pregnancy or lactation • Patients not agreeing to take adequate contraceptive measures during the study • Psychiatric disease • Any active , uncontrolled infection 7.3 Donors: Inclusion criteria • Age = 18 < 65 years • HLA-identical sibling donor by high resolution DNA-based HLA-A, -B, -C , -DRB1 typing. • HLA-identical unrelated donor by high resolution DNA-based HLA-A, -B, -C , -DRB1 typing . One allele mismatched (class I) can be accepted for recipients up to 60 years .

Study & Design

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