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Clinical Trials/EUCTR2008-001421-34-DE
EUCTR2008-001421-34-DE
Active, not recruiting
Not Applicable

Phase II Trial of Combined Immunochemotherapy withFludarabine, Mitoxantrone, Cyclophosphamide andAlemtuzumab (FMC-Alemtuzumab) in Patients withPreviously Treated or Untreated T-Prolymphocytic Leukemia - TPLL2

niversity of Cologne, Sponsor-Quality Management0 sites16 target enrollmentOctober 2, 2009
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Conditionsntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL .Therapeutic area: Diseases [C] - Cancer [C04]
DrugsFludaraMabCampath

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL .
Sponsor
niversity of Cologne, Sponsor-Quality Management
Enrollment
16
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 2, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Cologne, Sponsor-Quality Management

Eligibility Criteria

Inclusion Criteria

  • •Untreated patients with T\-prolymphocytic leukemia (T\-PLL) according to WHO criteria
  • •or pretreated patients (max. two previous treatment) with T\-PLL
  • •Age \= 18 years, ? 19 years for Austria
  • •WHO performance status of 0\-2
  • •Life expectancy \> 6 months
  • •CIRS score ? 6
  • •Left ventricular ejection fraction \=50% confimed by echo\-cardiogram performed \< 6 months before inclusion to the trial and after the end of a possible anthracycline\-contai\-ning pretreatment
  • •Adequate liver function as indicated by a total bilirubin, AST and ALT ? 2 the institional ULN value, unless directly attributable to the T\-PLL
  • •Creatinine clearance ? 60 ml/min calculated according to the formula of Cockcroft and Gault
  • •Seronegativity for HIV, HBV or HCV confirmed by serolo\-gical testing within 6 weeks prior to registration

Exclusion Criteria

  • •Clinically significant auto\-immune cytopenia or clinically significant hemolytic anaemia with suspicion of an immune origin, even if the Coombs test is negative
  • •Active secondary malignancy requiring treatment (except basal cell carcinoma or tumor curatively treated by surgery)
  • •Medical condition requiring prolonged use of oral corticosteroids (\> 1 month)
  • •Cerebral dysfunction, legal incapacity
  • •Any circumstance at the time of study entry that would preclude completion of the study and required follow\-up
  • •Active infection or severe infection (WHO 4th degree) within the last three months before inclusion to the study
  • •Participation in any other clinical trial during this study
  • •Known hypersensitivity to any of the study medications (Fludarabine, Cyclophospha\-mide, Mitoxantrone or Alemtuzumab)
  • •Patients who have already received more than 60% of the recommended maximum cumulative dose of an anthracycline (Epirubicine, Adriamycine or Mitoxantrone).
  • •This maximum cumulative dose is defined for the individual substances as follows:

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Not Applicable
Patients who suffer from T-Prolymphocytic leukemia and have received none or one chemotherapy so far will be treated with Fludarabine, Cyclophosphamide, Mitoxantrone and Alemtuzumab.ntreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL.Therapeutic area: Diseases [C] - Cancer [C04]
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