Bendamustine and Rituximab (BR) as Induction and Maintenance in Relapsed and Refractory Chronic Lymphocytic Leukemia

P

Pirogov Russian National Research Medical University

Status

Unknown

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: BR as Maintenance

Study type

Observational

Funder types

Other

Identifiers

NCT03847727
RSMU-CLL-2013

Details and patient eligibility

About

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 patients who attained a long progression-free survival (PFS) with the previous regimen. Bendamustine and rituximab (BR) is one of the most widely adopted CIT regimens, including second-line treatment. Unfortunately, durations of remission following BR combination therapy tend to be short in patients with heavily pre-treated disease or who have already received rituximab. The incorporation of a maintenance following induction chemotherapy to overcome the shorter remission durations in this population is a reasonable option.

Enrollment

112 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • 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.

Trial design

112 participants in 2 patient groups

Experimental: 6 cycles BR -> 4 x BR
Description:
Induction plus BR as maintenance (N=56)
Treatment:
Drug: BR as Maintenance
Proper historical control: 6 cycles BR
Description:
Induction only (N=56)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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