Safety and Efficacy of BKM120 in Relapsed and Refractory NHL

Completed · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

In brief

This is a phase II study evaluating the safety, tolerability and efficacy of BKM120 in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL) or follicular lymphoma (FL).

Key facts

Study ID

NCT01693614

Run by

Novartis Pharmaceuticals

People needed

72

Starts

2013-02-28

Expected to finish

2017-07-21

Last updated by the study team

2018-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
• Patient had relapsed or refractory disease and received at least one prior therapy.
• Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
• Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
• Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patient had adequate bone marrow and organ function.

You may not qualify if…

• Patient had received previous treatment with PI3K inhibitors
• Patient had evidence of graft versus host disease (GVHD).
• Patient had active or history of central nervous system (CNS) disease.
• Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
• Patient had a score ≥ 12 on the PHQ-9 questionnaire.
• Patient had a GAD-7 mood scale score ≥ 15.
• Pregnant or nursing women
• Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Nebraska Medical Center Univ Nebraska — Omaha, Nebraska, United States
• Memorial Sloan Kettering Dept of Onc. — New York, New York, United States
• Medical University of South Carolina -Hollings Cancer Center Medical Univ of South Carolina — Charleston, South Carolina, United States
• University of Texas MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3) — Houston, Texas, United States
• Novartis Investigative Site — Bruges, Belgium
• Novartis Investigative Site — Yvoir, Belgium
• Novartis Investigative Site — Marseille, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Rennes, France
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Würzburg, Germany
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Gyeonggi-do, Korea, South Korea
• Novartis Investigative Site — Seoul, Korea, South Korea
• Novartis Investigative Site — Salamanca, Castille and León, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Izmir, Turkey (Türkiye)
• Novartis Investigative Site — Samsun, Turkey (Türkiye)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.