A clinical trial to study the effects of two drugs, 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

Not Applicable

• Conditions: Health Condition 1: null- B-cell chronic lymphocytic leukemia

• Registration Number: CTRI/2013/08/003936
• Lead Sponsor: RCI Syntez CJSC Russia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 60

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified