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Combined Immunochemotherapy in Patients With T-Prolymphocytic Leukemia (T-PLL)

Information source: German CLL Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: T-cell-prolymphocytic Leukemia

Intervention: Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab (Drug); Alemtuzumab (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: German CLL Study Group

Summary

Study hypothesis: Simultaneous FMC-Alemtuzumab administration followed by Alemtuzumab maintenance therapy in patients with T-PLL is feasible, safe and efficient.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Remission Rate

Secondary outcome: Overall Survival Time

Detailed description: As the median survival time of patients with T-PLL is less than 12 months, the treatment of T-PLL is a special challenge. The overall response rates with conventional chemotherapy or Deoxycoformycin were low (about 30% and 40%), with the monoclonal antibody Alemtuzumab response rates of 50% to 70% were achieved, but the duration of the response was short. In the previous trial (T PLL 1), the efficacy of the FMC regimen (FMC = Fludarabine, Mitoxantrone and Cyclophosphamide) was tested, a preliminary analysis of 16 patients revealed a response rate of more than 60% after FMC-polychemotherapy and 83% after the subsequent administration of Alemtuzumab. The goal of the T-PLL2-protocol is to assess if the simultaneous administration of FMC-polychemotherapy and Alemtuzumab with a subsequent Alemtuzumab maintenance therapy is capable of improving the remission rate and the disease-free survival time in patients with T-PLL.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 serological 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 contraceptives 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

Exclusion Criteria:

- Clinically significant auto-immune cytopenia or clinically significant hemolytic

anaemia with suspicion of immune origin, even if 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:

- 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

- 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.

Locations and Contacts

University Hospital Cologne, Cologne 50924, Germany
Additional Information

Starting date: December 2009
Last updated: February 5, 2014

Page last updated: August 23, 2015

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