A Phase II study of BKM120 in patients with relapsed and refractory diffuse large B-cell lymphoma, mantle cell lymphoma and follicular lymphoma

Conditions: Diffuse large B-cell lymphoma, Mantle cell lymphoma and Follicular lymphoma
MedDRA version: 14.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 14.1Level: PTClassification code 10026801Term: Mantle cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-002208-41-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

1.Patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma. 2. Patient has relapsed or refractory disease and received at least one prior therapy. 3. Patient with diffuse large B cell lymphoma has received or is ineligible for autologous or allogeneic stem cell transplant. 4. Patient has at least one measurable nodal lesion (=2 cm) according to Cheson criteria (Cheson 2007). In case where the patient has no measurable nodal lesions = 2 cm in the long axis at baseline, then the patient must have at least one measurable extra-nodal lesion. 5. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status = 2. 6. Patient has adequate bone marrow and organ function.
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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

1. Patient has received previous treatment with PI3K. 2. Patient has evidence of graft versus host disease (GVHD). 3. Patient has active or history of central nervous system (CNS) disease. 4. Patient has a concurrent malignancy or has a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer). 5. Patient has a score = 12 on the PHQ-9 questionnaire. 6. Patient has a GAD-7 mood scale score = 15. 7. Pregnant or nursing women and who does not use highly effective contraception methods to avoid becoming pregnant or conciving offspring. Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of BKM120 in patients with relapsed/refractory Non-Hodgkin Lymphoma in the three different histological subgroups (cohorts);Secondary Objective: - To evaluate the safety and tolerability in the three different histological subgroups; - To assess progression free survival in the three different histological subgroups; - To assess the duration of response in the three different histological subgroups; - To assess overall survival in the three different histological subgroups.;Primary end point(s): Objective Response rate (ORR);Timepoint(s) of evaluation of this end point: Up to approx. 2 years when all cohorts are completed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Frequency and severity of adverse events. Other safety data as considered appropriate; - PFS progression free survival; - Duration of response; - OS Overall survival.;Timepoint(s) of evaluation of this end point: Up to 2 years when all cohorts are completed