A Phase II study of BKM120 in patients with relapsed and refractorydiffuse large B-cell lymphoma, mantle cell lymphoma and follicularlymphoma

Phase 1

Conditions: Diffuse large B-cell lymphoma, Mantle cell lymphoma and Follicularlymphoma
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-ES

Lead Sponsor: ovartis Farmacéutica S.A.

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:
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

1.1. 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;Secondary Objective: To evaluate the safety and tolerability in the three different histological subgroups<br><br>To assess progression free survival in the three different histological subgroups<br><br>To assess the duration of response in the three different histological subgroups<br><br>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 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<br>considered appropriate<br>PFS progression free survival<br>Duration of response<br>OS Overall survival.;Timepoint(s) of evaluation of this end point: up to 2 years when all cohorts are completed