Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2008-001421-34-AT
EUCTR2008-001421-34-AT
Active, not recruiting
Not Applicable

Phase II Trial of Combined Immunochemotherapy with Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (FMC-Alemtuzumab) in Patients with Previously Treated or Untreated T-Prolymphocytic Leukemia - TPLL2

niversität zu Köln0 sites16 target enrollmentJune 5, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
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]
DrugsFludaraEndoxan 'Baxter'MabCampathMitoxantron 'EBEWE'

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
niversität zu Köln
Enrollment
16
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 5, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversität zu Köln

Eligibility Criteria

Inclusion Criteria

  • •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)

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 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:

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]
EUCTR2008-001421-34-DEniversity of Cologne, Sponsor-Quality Management16
Active, not recruiting
Phase 1
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukaemia - CLL10
EUCTR2007-007587-21-DKGCLLSG - Dept. of Internal Medicine I, University Hospital Cologne550
Active, not recruiting
Phase 1
Patients who suffer from chronic lymphocytic leukemia and have not received any chemotherapy so far will be treated with fludarabine, cyclophosphamide and rituximab (FCR) or bendamustine and rituximab (BR)
EUCTR2007-007587-21-ATniversity of Cologne, Sponsor-Quality Management550
Active, not recruiting
Phase 1
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia
EUCTR2007-007587-21-DEniversity of Cologne550
Active, not recruiting
Phase 1
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia - CLL10patients (age 18 years or older) with chronic lymphocytic leukemia: Stage Binet C or stage Binet B and A requiring treatmentMedDRA version: 14.0Level: LLTClassification code 10009310Term: CLLSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
EUCTR2007-007587-21-CZGCLLSG - Dept. of Internal Medicine I, University Hospital Cologne550