AN INVESTIGATOR INITIATED OBSERVATIONAL STUDY TO EVALUATE THE RESPONSE RATE AND TOXICITY (SAFETY) OF THE COMBINATION OF BENDAMUSTINE AND RITUXIMAB (BR) IN FRESH ADULT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS
- Conditions
- Health Condition 1: null- CHEMO-NAIVE ADULT CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS
- Registration Number
- CTRI/2011/05/001772
- Lead Sponsor
- DrMBAgarwal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
1.Male or female patients between ages of 18 to 81 years (both years inclusive).
2.ECOG performance score of less than or equal to 2.
3.Untreated case of chronic lymphocytic leukemia.
4.Organ and marrow function as defined below:
a.Absolute neutrophil count: greater than or equal to 1.5 x 109 cells/L
b.Hemoglobin: greater than or equal to 9 g/dL
c.Platelets: greater than or equal to 75 x 109 cells/L
d.Lymphocyte count greater than or equal to 5x109 cells/L
e.Serum creatinine: less than 1.5 of ULN
5.Measurable in terms of
a.Lymphocytes presence or
b.Measurable Lymphadenopathy or
c.Bone marrow involvement greater than 30 percent
6.For female patients of child-bearing potential, a negative urine pregnancy test at Screening.
7.Current use of an acceptable form of double-barrier birth control:
a). female patients of childbearing potential must agree to use acceptable methods of birth control which include oral, injectable, transdermal or implantable hormonal contraceptives, intrauterine device, cervical diaphragm plus spermicide, or female condom plus spermicide during the study period and for 30 days after the last administration of drugs;
b) male patients must also agree to use acceptable methods of birth control with their partners and this may include use of a male condom plus spermicide; if the patient is practicing abstinence at the time of Screening, he/she must agree to use a double-barrier contraceptive method if he/she becomes sexually active.
8.Life expectancy should be at least 1 to 2 years as per the discretion of the investigator.
1.Patients with history of any other cancer.
2.Patients with known brain or other central nervous system disease.
3.Patients with serious concomitant systemic disorders incompatible with the study, at the discretion of the investigator.
4.Patients with any major organ malfunction.
5.Patients with a weakened immune system.
6.Patients with fever or other signs of infection at the time of screening that could interfere with the patients ability to participate in the study
7.Patients with severe skin problems.
8.Patients with severe mouth ulcers.
9.Patients with metabolic disorders.
10.Patient with electrolyte imbalances.
11.Patients who have a known history of Systemic Lupus Erythematosus.
12.Patients with the history of heart diseases. e.g., NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachy- arrhythmias requiring ongoing treatment, or unstable angina, or heart rhythm disorder.
13.Patients with the history of kidney failure and need dialysis.
14.Patients with the history of lung disease / breathing disorder / upper respiratory tract infection / other severe or chronic pulmonary diseases that could interfere with the patients ability to participate in the study.
15.Patients with the history of Progressive multifocal leukoencephalopathy.
16.Patients with the history of bowel obstruction and perforation.
17.Patients with the problem of severe constipation.
18.Patients with the history of gastrointestinal disorders like nausea, vomiting, and diarrhea that could interfere with the patients ability to participate in the study.
19.Patients with the history of psychological problems that would preclude participation in the study (like confusion, hallucination, loss of balance, change in the way one walks or talks, decreased strength or weakness on one side of your body, blurred vision or loss of vision).
20.Patients with AST greater than or equal to 2.5 of ULN.
21.Patients with ALT greater than or equal to 2.5 of ULN.
22.Patients with Bilirubin greater than or equal to 1.5 of ULN.
23.Patients with Creatinine Clearance of less than 40mL/min.
24.Patients with Hyperuricemia at the discretion of the investigator.
25.Patients with high potassium levels at the discretion of the investigator.
26.Patients with high calcium levels at the discretion of the investigator.
27.Patients with the symptoms of flu at the time of screening that could interfere with the patients ability to participate in the study.
28.Patients with clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.
29.Patients with a known history of HIV.
30.Patients who are allergic to mouse proteins in general.
31.Patients who have had a vaccination recently or are scheduled to receive vaccinations.
32.Patients with a known hypersensitivity to Bendamustine.
33.Patients with a known hypersensitivity to Mannitol.
34.Patients with known hypersens
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method