Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma Clinical Trial
Official title:
An Open-label Phase II Study of BKM120 in Subjects With Relapsed and Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma and Follicular Lymphoma
| Verified date | August 2018 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | July 21, 2017 |
| Est. primary completion date | July 21, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma. 2. Patient had relapsed or refractory disease and received at least one prior therapy. 3. Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant. 4. 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. 5. Patient had an Eastern Cooperative Oncology Group (ECOG) performance status = 2. 6. Patient had adequate bone marrow and organ function. Exclusion Criteria: 1. Patient had received previous treatment with PI3K inhibitors 2. Patient had evidence of graft versus host disease (GVHD). 3. Patient had active or history of central nervous system (CNS) disease. 4. 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). 5. Patient had a score = 12 on the PHQ-9 questionnaire. 6. Patient had a GAD-7 mood scale score = 15. 7. Pregnant or nursing women 8. Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novartis Investigative Site | Brugge | |
| Belgium | Novartis Investigative Site | Yvoir | |
| France | Novartis Investigative Site | Marseille | |
| France | Novartis Investigative Site | Pierre-Benite Cedex | |
| France | Novartis Investigative Site | Rennes | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Wurzburg | |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Milano | MI |
| Korea, Republic of | Novartis Investigative Site | Gyeonggi-do | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Spain | Novartis Investigative Site | Hospitalet de LLobregat | Catalunya |
| Spain | Novartis Investigative Site | Salamanca | Castilla Y Leon |
| Turkey | Novartis Investigative Site | Izmir | |
| Turkey | Novartis Investigative Site | Samsun | |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| 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 | Memorial Sloan Kettering Dept of Onc. | New York | New York |
| United States | University of Nebraska Medical Center Univ Nebraska | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Belgium, France, Germany, Italy, Korea, Republic of, Spain, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) and Disease Control Rate (DCR) Per Investigator at 6 Months (FAS) | Overall Response rate is the percentage of patients in a cohort who experienced either complete response (CR) or partial response (PR) during their follow-up after treatment start divided by the total percentage of patients included in the corresponding cohort according to Cheson criteria The analysis for each cohort was based on an exact binomial test comparing the ORR to the reference level of 10% (null hypothesis) in the FAS. The test for each cohort used a significance level of 5%. The ORR was presented together with an exact 95% Clopper- Pearson confidence interval. Disease Control Rate (DCR progressive. Disease Control Rate (DCR) was the percentage of patients with CR, PR or SD (stable disease). Patients for whom the best response after treatment start was missing, unknown (UNK) or progressive disease (PD) were considered non-responders and were counted in the denominator for the estimation of the ORR | Baseline up to 6 months | |
| Secondary | Progression- Free Survival (PFS) Based on Investigator Assessment (FAS) | Progression-free survival (PFS) is the time from the date of treatment start to the date of the first documented progressive disease (PD) or death due to any cause using Kaplan-Meier method by cohort. | Baseline up to approximately 44 months | |
| Secondary | Duration of Response for Diffuse Large B-cell Lymphoma (DLBCL), and Follicular Lymphoma (FL) Cohorts (FAS) | Duration of response is the time from the date of first occurrence of complete response (CR) or partial response (PR) to the date of the first documented progressive disease (PD) or death due to any cause | Baseline up to approximately 18 months | |
| Secondary | Overall Survival (OS) - Percentage of Participants With OS Events (FAS) | Overall survival (OS) is the time from treatment start to the date of death due to any cause. Participants not known to have died were censored at the date of their last visit | Baseline up to approximately 44 months | |
| Secondary | Percentage of Participants - Overall Survival- Kaplan Meier Estimates (FAS) | Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals | Baseline up to approximately 18 months | |
| Secondary | Overall Survival - Median (FAS) | Overall survival (OS) is the time from treatment start to the date of death due to any cause. Estimates done by cohort using Kaplan-Meier method with 95% confidence intervals | Baseline up approximately 44 months |