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

NCT03847727 | Unknown

• 1 other identifier: RSMU-CLL-2013
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia; Bendamustine Hydrochloride; Rituximab; Maintenance

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  PFS is defined as the number of days from the date of first dose of any study drug (rituximab or bendamustine) to the date of disease progression or death, whichever occurs first. PFS will be compared with its proper historical control (BR as induction without subsequent maintenance).

  42 months

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Approximately 24 months after initial dose of study drug.

• Overall Survival (OS)

  60 months (6 months induction therapy, 12 months maintenance, 42 months long-term follow-up

• Safety evaluations

  Up to 30 months

• Health Related Quality of Life (HRQoL)

  Up to 30 months

Study Arms (2)

Experimental: 6 cycles BR -> 4 x BR

Induction plus BR as maintenance (N=56)

Drug: BR as Maintenance

Proper historical control: 6 cycles BR

Induction only (N=56)

Interventions

BR as Maintenance DRUG

Patients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy.

Experimental: 6 cycles BR -> 4 x BR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with relapsed or refractory CLL receiving treatment at the University Hematology Hospital and Ambulant clinic.

You may qualify if:

• 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.
• At least a partial response (PR or better; Hallek et al, 2008) must be achieved after induction of BR (phase A)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Semochkin Sergey

Moscow, Ostrovitianov Str. 1, 117997, Russia

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Sergey Semochkin, Professor

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: February 20, 2019
• Study Start: December 3, 2013
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2020
• Last Updated: January 18, 2020

Record last verified: 2019-12

Locations

RU (1)