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Clinical Trials/EUCTR2010-022052-23-IT
EUCTR2010-022052-23-IT
Active, not recruiting
Phase 1

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

GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS0 sites60 target enrollmentSeptember 19, 2011
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DrugsTEPADINABUSILVEX

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS
Enrollment
60
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 19, 2011
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
GITMO GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO,CELLULE STAMINALI EMOPOIETICHE E TERAPIA CELLULARE - ONLUS

Eligibility Criteria

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 .

Outcomes

Primary Outcomes

Not specified

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