Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 10:48 AM
Study NCT ID:
NCT01719250
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2012-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Buparlisib in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Pilot Study of the PI3K Inhibitor BKM120 in Patients With Relapsed Lymphoma
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot clinical trial studies how well buparlisib works in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Buparlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the clinical benefit rate (complete response \[CR\], partial response \[PR\] or standard disease \[SD\] \>= 6 months) with BKM120 (buparlisib) in patients with relapsed or refractory lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate overall response rate, overall survival, progression-free survival and duration of response.
II. To describe the toxicities associated with BKM120 in lymphoma. III. To evaluate prognostic factors for aggressive lymphoma and whether there's a correlation with clinical benefit.
TERTIARY OBJECTIVES:
I. To assess serum cytokines before and after BKM120 therapy. II. To assess phosphatidylinositol 3-kinase (PI3K) pathway member expression on paraffin-embedded tumor samples pre-treatment.
III. To assess on paired fresh tumor tissue obtained from consenting patients pre- and post-therapy the change in activation of PI3K pathway members.
OUTLINE: Patients receive buparlisib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
I. To evaluate the clinical benefit rate (complete response \[CR\], partial response \[PR\] or standard disease \[SD\] \>= 6 months) with BKM120 (buparlisib) in patients with relapsed or refractory lymphoma.
SECONDARY OBJECTIVES:
I. To evaluate overall response rate, overall survival, progression-free survival and duration of response.
II. To describe the toxicities associated with BKM120 in lymphoma. III. To evaluate prognostic factors for aggressive lymphoma and whether there's a correlation with clinical benefit.
TERTIARY OBJECTIVES:
I. To assess serum cytokines before and after BKM120 therapy. II. To assess phosphatidylinositol 3-kinase (PI3K) pathway member expression on paraffin-embedded tumor samples pre-treatment.
III. To assess on paired fresh tumor tissue obtained from consenting patients pre- and post-therapy the change in activation of PI3K pathway members.
OUTLINE: Patients receive buparlisib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01582 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MC1183 | OTHER | Mayo Clinic | View | |
| P30CA015083 | NIH | None | https://reporter.nih.gov/quic… | View |