CTRI/2013/08/003936Not yet recruiting未知
Randomized Comparative Study of Efficacy and Safety of Fludarabine (Biosyntez Laboratories Private Limited, India) in Combination with Cyclophosphamide versus Fludara® (German Remedies, India) in Combination with Cyclophosphamide in Patients with Chronic Lymphocytic Leukemia
RCI Syntez CJSC Russia0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Male and female patients aged over 18 years
- •2. Confirmed immunophenotypic diagnosis of B-cell chronic lymphocytic leukemia previously untreated
- •3. Stage D, C, or A of the disease with the progression (lymphocyte doubling time less than < 6 months, a steady increase in the lymph nodes and spleen, fever, fatigue, weight loss)
- •4. The ECOG status of < 2 with the expected level of survival > 12 months
- •5. Fertile women capable should use a reliable contraception method (in this study acceptable methods are as follows: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, sustained-release injectable contraceptives, partnerâ??s vasectomy and double-barrier method (condom or diaphragm with spermicide)
- •6. Male patients should agree to use contraception (themselves or ensure that their partner uses) in the study
- •7. A signed informed consent to participate in the study
- •8. Patientâ??s desire and ability to meet the requirements of the protocol in the study
Exclusion Criteria
- •Concomitant disease or pathology which makes it impossible to participate in the study or any serious disease or condition which would pose a threat to the patientâ??s safety in case of participation in the study.
- •Active viral, bacterial or fungal infection which can not be resolved at the time of inclusion in the study, HIV-infection
- •Another malignant disease at the time of inclusion in the study except for basal cell skin cancer.
- •Chemotherapy for other malignant disease less than twelve months prior to the study inclusion.
- •Autoimmune hemolytic anemia.
- •Richter syndrome
- •Creatinine clearance less than 30 ml/min.
- •Clinically significant cardiovascular or cerebrovascular disease within six months prior to a visit, such as acute myocardial infarction, unstable angina, significant ventricular arrhythmias, severe congestive heart failure, stroke, or uncontrolled hypertension.
- •Any clinically significant changes in ECG because of which, as the investigator thinks, the patient can not participate in the study.
- •Liver impairment and acute hepatitis of any etiology.
- •Any organic or psychiatric disorder which, as the researcher thinks may interfere with the patient participation in the study or interfere with the interpretation of the study results.
- •Pregnancy, lactation.
- •Participation in another clinical trial.
- •Fertile patients who do not agree to use effective contraception in the treatment period.
- •Inability to use the drug by intravenous injection.
- •Patients with suspected hypersensitivity to fludarabine or excipients.
- •Patients with any clinically significant laboratory abnormalities that are not connected with cancer.
- •Uncontrolled hypercalcemia
- •Patients with alcohol or drug addiction in medical history, including persons who use more than 30 grams of alcohol per day.
- •Patients who are clearly or probably will be unable to understand and evaluate the information provided to them as a part of the policy information e.g. informed consent, in particular, with respect to the expected risks and possible discomfort.
Investigators
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