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An Open-label Phase II Study of BKM120 in Patients With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma

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Trial Information

An Open-label Phase II Study of BKM120 in Patients With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma


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.

Exclusion Criteria:

1. Patient has received previous treatment with PI3K inhibitors

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

8. Patient who does not use highly effective contraception methods to avoid becoming
pregnant or conceiving offspring.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response rate

Outcome Description:

Objective Response rate is the number of patients in a cohort who experience either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total number of patients included in the corresponding cohort

Outcome Time Frame:

Treatment continues in cycles of 28 days until disease progression, intolerable toxicity, other criteria for discontinuation, or 6 months after the last patient in that cohort has started BKM120, whichever comes first.

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBKM120Z2402

NCT ID:

NCT01693614

Start Date:

February 2013

Completion Date:

March 2015

Related Keywords:

  • Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma
  • Diffuse large B-cell lymphoma, Mantle cell lymphoma, Follicular lymphoma, PI3K inhibitor, Non-Hodgkin lymphoma, NHL
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Mantle-Cell

Name

Location

MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(3)Houston, Texas  77030-4009
Massachusetts General Hospital Dept of OncBoston, Massachusetts  02114
University of Massachusetts Medical Center Dept of OncologyWorcester, Massachusetts  01655
University of Nebraska Medical Center Univ NebraskaOmaha, Nebraska  68198
Memorial Sloan Kettering Cancer Center Dept of Onc.New York, New York  10021
Medical University of South Carolina Medical Univ if South CarolinaCharleston, South Carolina  29425