Patient with chronic lymphocytic leukemia (CLL) requiring therapy with a high risk factor such as 17p deletion or refractoriness to fludarabine . MedDRA version: 9.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia MedDRA version: 9.1 Level: LLT Classification code 10008978 Term: Chronic lymphocytic leukemia refractory
Conditions
Interventions
Trade Name: MabCampath
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Neulasta
Pharmaceutical Form: Concentrate for solution for injection
Trade Name: Dexamethasone
Product
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following criteria are to be checked at the time of study entry. The patient may only be included if all of the following statements are true: 1. The patient has CLL requiring treatment (Binet C or A/B with “active disease” according to the NCI criteria). 2.One or both of the following is true: • The patient's disease is refractory to any previous fludarabine-containing regimen, defined as no CR or PR according to NCI criteria, or progression within 6 months after any fludarabine-containing regime. (N.B.: Within the framework of this trial, the term “fludarabine-refractory” is synonymous to a refractory status to any established purine analogue (i.e. pentostatin, cladribine).) • 17p deletion is present (irrespective of whether previously treated or untreated). 3. The patient is at least 18 years of age. 4. The patient's performance status is 0, 1 or 2 on the WHO/ECOG scale. 5. Any previous chemotherapy and/or immunotherapy ended at least four weeks before the first study treatment with alemtuzumab. 6. The patient has recovered from all previous chemotherapy and/or immunotherapy. 7. For fertile men and for women of childbearing potential: Adequate contraception (oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly). 8. The patient has given written informed consent to participate in the study. 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
Exclusion criteria
Exclusion criteria: The following criteria are to be checked at the time of study entry. The patient must be excluded if any one (or more) of the following statements is true: 1. The patient has received more than five different prior therapeutic regimens. 2.Any major organ dysfunction is present (e.g. unstable angina pectoris, NYHA III/IV heart insufficiency, significant coronary stenoses, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary disease with hypoxemia, renal failure). 3. Any of the following laboratory values are found at the screening visit to be >2x the upper limit of the normal range: serum creatinine, serum bilirubin, ASAT, ALAT. 4. Any active infection is present. 5. B-PLL or Richter transformation is diagnosed or suspected (symptoms or cytology). 6. There is involvement of the central nervous system. 7. The patient is known to be positive for human immunodeficiency virus (HIV). 8. CMV viremia is present, as demonstrated by pp65 EA or CMV-DNA. 9. The patient has previously been treated with alemtuzumab. 10. The patient has received autologous or allogeneic SCT within the past six months. 11. The patient is receiving long-term systemic treatment with corticosteroids or has received such treatment in the four weeks before first treatment with alemtuzumab. 12. Any additional active malignancy is present. 13. The patient has ever had an anaphylactic response to humanized antibodies. 14. For female patients: The patient is pregnant or lactating. 15. The patient has a history of drug or alcohol abuse that might lead to inability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the efficacy of the study treatment in the study population in terms of: – Response rate ;Secondary Objective: Progression-free survival, defined as time from study entry until diagnosis of PD or death of any cause • Failure-free survival, defined as time from study entry until initiation of next treatment, diagnosis of PD or death of any cause. • Overall survival, defined as time from study entry until death. • Acquisition of further data to expand the data base on the toxicity of the study treatment. • Assessment of the efficacy of the study treatment in biological risk groups. • Assessment of response in terms of MRD. ;Primary end point(s): The objective response rate (ORR = number of patients with CR or PR / number of evaluable subjects) according to the NCI working-group criteria. | — |
Countries
Austria, France, Germany
Outcome results
None listed