A Study for Patients With Non-Hodgkin's Lymphomas

B-Cell Lymphoma Clinical Trial

Official title:

A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542919
• Other study ID #: 11503
• Secondary ID: H6Q-MC-S057
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Est. completion date: February 27, 2018

Study information

• Verified date: September 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:

• T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)

• Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma

• Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 27, 2018
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have measurable lesions

• Have recovered from prior chemotherapies

• Have an estimated life expectancy of at least 12 weeks

• Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present)

• Renal: serum creatinine less than or equal to 1.5XULN

• Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria:

• Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation).

• Anti-lymphoma therapy within the past 3 weeks

• Unable to swallow tablets

• Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment

Related Conditions & MeSH terms

• B-Cell Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• T-Cell Lymphoma

Intervention

Drug:
• enzastaurin
1125 mg loading dose then 500 mg, oral, daily until progressive disease

Locations

Country	Name	City	State
Australia	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Auchenflower	Queensland
Australia	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Garran	Australian Capital Territory
Australia	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gosford	New South Wales
Australia	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Prahran	Victoria
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brasilia
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Curitiba
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Jau
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Porto Alegre
Brazil	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	São Paulo
Mexico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Monterrey
Mexico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tepic
Mexico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tlalpan
Peru	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lima
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Mexico,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])	Tumor RR is defined as the number of responders divided by the number of treated participants for that tumor subtype. A responder was a participant who exhibited: a CR defined as a modified severity-weighted assessment tool (mSWAT) value of zero or a partial response (PR) defined as a mSWAT value > 50% decrease from baseline [for participants with cutaneous T-cell lymphoma (CTCL) using the mSWAT or CR, unconfirmed CR (Cru), or PR as defined by Abrey et al., (2005) (for participants with central nervous system (CNS) Lymphoma); or for all other participants a CR or complete response - unconfirmed (CRu) or PR as defined by Cheson et al., (1999).	Baseline to Measured Progressive Disease (Up to 114 Months)
Secondary	Progression Free Survival (PFS)	Progression-free survival is defined as the time from the date of study enrollment to the first date of objectively determined progressive disease or death from any cause. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.	Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)
Secondary	Time to Progressive (TTP) Disease	TTP disease is defined as the time from the date of study enrollment to the date of objectively determined disease progression. Objectively determined progressive disease (PD) was interpreted as meeting the criteria for PD. For patients who died without documented objective PD (including death from study disease); TTP was censored at the date of the last objective progression-free disease assessment prior to death. For participants not known to have died as of the data cut-off date and who did not have objective PD, TTP was censored at the date of the last objective progression-free disease assessment. For participants who received subsequent anticancer therapy (after discontinuation from study treatment) prior to objectively determined disease progression, TTP was censored at the date of the last objective progression free disease assessment prior to post-discontinuation therapy.	Baseline to Measured Progressive Disease (Up to 114 Months)
Secondary	Duration of Response (DOR)	DoR is defined as the time from the date when the measurement criteria were met for CR, CRu, or PR (whichever status was recorded first) until the date of first observation of objectively determined disease progression (CR, CRu, or PR see above definition of responder). For responding participants who died without PD (including death from study disease), DoR was censored at the last assessment demonstrating lack of progression. For responding patients not known to have died as of the data cut-off date and who did not have PD, DoR was censored at the last assessment demonstrating objective response prior to the data cut-off date. For responding participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression, DoR was censored at the last assessment demonstrating objective response prior to the initiation of post-discontinuation anticancer therapy.	Baseline to Measured Progressive Disease (Up to 97 Months)
Secondary	Percentage of Participants With Progression Free Survival (PFS) at 1-Year	PFS at 1 year was defined as the probability of being alive and having not progressed at 1 year and calculated from the PFS Kaplan-Meier analysis. PFS was censored at the date of the last objective progression-free assessment. Progressive disease (PD) is an increase of Sézary cell percentage by greater than or equal to 40% in cluster of differentiation (CD4+/CD7- or 30% in CD4+/CD26- as compared to each respective nadir. mSWAT, primary central nervous system lymphoma (PCSNSL) and International Workshop Response Criteria (IWRC) response criteria were used for CTCL, primary central nervous system lymphoma (CNSL) and all other participants respectively. PFS was censored at the date of the last objective progression-free assessment.	Baseline to Measured Progressive Disease or Death From Any Cause (1 Year)
Secondary	Number of Participants With One or More Drug-Related Adverse Events	Number of participants with one or more Drug-Related Adverse Events. Clinically significant events are defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.	Baseline to End of Study (Up to 114 Months)

External Links

•   Lilly Clinical Trial Registry