A phase II/III trial to assess the use of obinutuzmab against no treatment in patients who have recently had a good response to previous treatment for Chronic Lymphocytic Leukaemia (CLL)

• Conditions: Chronic Lymphocytic Leukaemia (CLL).; MedDRA version: 17.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-000880-42-GB
• Lead Sponsor: niversity of Leeds

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 30 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

•At least 18 years old
•Previous confirmation of B-CLL with a characteristic immunophenotype (for example, CD5+, CD19+, CD23+ lymphoproliferative disorder) on peripheral blood flow cytometry
•Maximum of three prior therapies received for CLL treatment and between 3 and 24 months post therapy at registration.
•Response to most recent chemotherapy treatment for CLL with PR, CRi or CR
•World Health Organisation (WHO) performance status (PS) of 0 or 1
•Able to provide written informed consent
•Peripheral B-Cell count <5x10^9 L
•For randomisation, the first MRD positive peripheral blood sample (disease level found in peripheral blood is greater than 0.01%) must be between 3 and 12 months since completing most recent therapy for CLL
•Absence of clinically or radiologically evident lymphadenopathy (largest lymph node 1.5 cm or less in minimum diameter)
•Creatinine and bilirubin <2 times upper limit of normal unless secondary to direct infiltration of the liver by CLL or haemolysis

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 128
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Disease progression after response to latest therapy
•Active infection
•Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies
•Previous treatment with obinutuzumab
•CNS involvement with CLL
•Mantle cell lymphoma
•Moderate or severe cardiac disease that would preclude treatment with obinutuzumab
•Other severe, concurrent diseases or mental disorders that could interfere with ability to participate
•Known HIV positivity
•Active secondary malignancy excluding basal cell carcinoma
•Active haemolysis
•Patients previously treated with allogeneic Stem Cell Transplant
•Pregnancy, lactation or women of child-bearing potential unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished
•Men whose partners are capable of having children but who are not willing to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished, unless they are surgically sterile
•Persisting severe pancytopenia (neutrophils <0.5 x 10^9/L or platelets <50 x 10^9/L) or trans fusion dependent anaemia
•Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
•Positive serology for Hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified