Status:
UNKNOWN
Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Pirogov Russian National Research Medical University
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
CLL is an incurable disease with conventional chemotherapy. In the absence of TP53 disruption, a chemoimmunotherapy (CIT) regimen is recommended as front-line and second-line treatment in those patien...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of CD20-positive CLL that meets the iwCLL criteria (Hallek et al, 2008).
- Relapsed or refractory status of disease after at least one prior chemotherapy regimen.
- ECOG performance status of 0-2 at study entry
- Patients have not received prior therapy with bendamustine
- Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.
- For inclusion in the research part of maintenance therapy (phase B):
- At least a partial response (PR or better; Hallek et al, 2008) must be achieved after induction of BR (phase A)
Exclusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document or complying with the protocol treatment.
- Pregnant or breast-feeding females.
- Known to be positive for human immunodeficiency virus (HIV) or infectious hepatitis (type B or C).
- Patients are not eligible if there is a prior history or current evidence of central nervous system or leptomeningeal involvement.
- Richter syndrome or chronic prolymphocytic leukemia.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
- Concurrent use of other anti-cancer agents or treatments.
- Laboratory test results within these ranges: ANC ≤ 1000/μL, Platelet count ≤ 75,000/μL.
- Total bilirubin Total bilirubin ≥ 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
- Serum transaminases AST (SGOT) and ALT (SGPT) ≥ 3 x ULN, and/or serum alkaline phosphatase ≥ 5 X ULN.
- New York Heart Association class 3-4 heart failure.
Key Trial Info
Start Date :
December 3 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2020
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03847727
Start Date
December 3 2013
End Date
December 3 2020
Last Update
January 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Semochkin Sergey
Moscow, Ostrovitianov Str. 1, Russia, 117997