Untreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL .
Conditions
Interventions
Trade Name: Fludara
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 75607-67-9
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: range
Concentration number
Sponsors
University of Cologne, Sponsor-Quality Management
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
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: - Epirubicin 900 mg/m² - Daunorubicin 550 mg/m², (or 400 mg/m² if the patient received mediastinal irradiation) - Adriamycine (Doxorubicine) 550 mg/m² - Mitoxantrone 200 mg/m² • Patients who already received Fludarabine in combination with Cyclophosphamide or Mitoxantrone during the last 6 months before inclusion into the trial. • Patients who received prior treatment with Alemtuzumab alone or in combination with a purine analogue and who did not achieve a PR that lasted at least 6 months • Patients who are employees of the Sponsor (University of Cologne) or the study sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the T-PLL2-study is to assess remission rate, number of serious adverse events, number of life-threatening infections of simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab-maintenance therapy in patients with T-PLL. ;Secondary Objective: The objective of the T-PLL2-study is to assess overall survival time, progression-free survival time, duration of remission of simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab-maintenance therapy in patients with T-PLL. ;Primary end point(s): Remission rate • Number of serious adverse events • Number of life-threatening infections ;Timepoint(s) of evaluation of this end point: planned December 2017 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall survival time • Progression-free survival time • Duration of remission ;Timepoint(s) of evaluation of this end point: planned December 2017 | — |
Countries
Austria, Germany
Contacts
Public ContactAnne Westermann
German CLL Study Group
Outcome results
None listed