Health Condition 1: null- B-cell chronic lymphocytic leukemia
Conditions
Interventions
Intervention1: Fludarabine: 1 vial contains:
Active Ingredient: Fludarabine phosphate 50 mg.
Excipients: mannitol 100.0 mg, sodium hydroxide q.s. for intravenous use.
Three cycles in every 28 days the
Sponsors
RCI Syntez CJSC Russia
Eligibility
Inclusion 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 4. The ECOG status of 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.General response level and number of complete and partial clinical and hematological remission after fludarabine therapy. 2.Therapy response rate in these clinical examination 3.Safety of fludarabine (hematologic and nonhematologic toxicity) by the number of adverse events. Timepoint: After three chemotherapy cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the progression-free survival in the two treatment groups based on the investigatorâ??s tumor evaluation.Timepoint: After three chemotherapy cycles | — |
Countries
India
Contacts
Public ContactDr Amit Bhatt
Nexus Clinical Research (India) Ltd.
Outcome results
None listed