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.
- Conditions
- 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]
- Registration Number
- EUCTR2008-001421-34-AT
- Lead Sponsor
- niversität zu Köln
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
•Untreated patients with T-prolymphocytic leukemia (T-PLL) according to WHO criteria or pretreated patients (max. one previous treatment) with T-PLL
•Age = 18 years
•WHO performance status of 0-2
•Life expectancy > 6 months
•CIRS score <= 6
•Left ventricular ejection fraction =50% confirmed by echo-cardiogram performed < 6 months before inclusion to the trial and after the end of a possible anthracycline-containing pretreatment
•Adequate liver function as indicated by a total bilirubin, AST and ALT ? 2 the institutional ULN value, unless directly attributable to the T-PLL
•Creatinine clearance >= 70 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
•Willingness of fertile male and female patients to use a highly effective contraceptive method with a Pearl-Index < 1 during and at least six months after the end of the study treatment (e.g. implants, injectables, oral contra-ceptives in combination with another contraceptive method, some IUDs, sexual abstinence or vasectomised partner)
•Negative serum pregnancy test one week prior to treatment (required for female patients before and <2 years after onset of menopause)
•Patient's written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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 tumour 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, Cyclophosphamide, 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:
-Epirubicine: 900mg/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 combina-tion with Cyclophosphamide or Mitoxantrone
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- Number of serious adverse events<br>- Number of life-threatening infections;Timepoint(s) of evaluation of this end point: planned December 2017
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Overall survival time<br>- Progression-free survival time<br>- Duration of remission;Timepoint(s) of evaluation of this end point: planned December 2017