Status:
COMPLETED
Study to Compare Busulfan-fludarabine With Thiotepa-fludarabine Regimen in Allogeneic Transplantation for Myelofibrosis
Lead Sponsor:
Gruppo Italiano Trapianto di Midollo Osseo
Conditions:
Myelofibrosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study will be performed as a prospective multicenter phase II trial for compare busulfan-fludarabine reduced-intensity conditioning (RIC) with thiotepa-fludarabine RIC regimen prior to allogeneic...
Detailed Description
This is the first study to explore the efficacy of two different Reduced-intensity conditioning (RIC) regimens for allogeneic stem cell transplantation in myelofibrosis. The choice of 60 patients is b...
Eligibility Criteria
Inclusion
- Age ≥ 18 ≤ 70 years
- Primary or secondary myelofibrosis after essential thrombocythemia or polycythemia vera
- One of the following unfavourable prognostic factors: Hb \< 10 g/dL or leukocytes \>25x109/L or \> 1% circulating blasts in the peripheral blood or constitutional symptoms
- Performance Status (Karnofsky)≥ 60%
- Hematopoietic Cell Transplantation Comorbidity Score ≤ 5
- Written informed consent
Exclusion
- ≥ 20% blasts in peripheral blood and/or bone marrow
- Positive serologic markers for human immunodeficiency virus (HIV)
- Acute hepatitis B virus (HBV) or acute hepatic C virus (HCV) infection
- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as: --total bilirubin, Serum Glutamate Oxaloacetate Transaminase (SGOT) or Serum Glutamate Pyruvate Transaminase (SGPT) \> 5 the upper normal limit;
- Left ventricular ejection fraction \< 40%;
- Clearance creatinine \< 30 ml/min;
- Diffusing Capacity of Lung for Carbon monoxide (DLCO) \< 30% and/or receiving supplementary oxygen.
- Pregnancy or lactation
- Any active, uncontrolled infection
- Donors:
- Age ≥ 18 \< 65 years
- human leukocyte antigen (HLA)-identical sibling donor by high resolution DNA-based HLA-A, -B, -C, -DRB1, typing
- human leukocyte antigen (HLA)-identical unrelated donor by high resolution DNA-based human leukocyte antigen-A, human leukocyte antigen-B, human leukocyte antigen-C, human leukocyte antigen-DRB1 typing. One allele mismatched (class I) can be accepted for recipients up to 60 years.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01814475
Start Date
July 1 2011
End Date
December 31 2016
Last Update
August 20 2021
Active Locations (21)
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1
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, Italy
2
Clinica di Ematologia - Ospedali Riuniti di Ancona
Ancona, Italy
3
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
4
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, Italy