Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Nov 2007

Longer than P75 for phase_2

Geographic Reach

5 countries

14 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.3 years study duration

First Submitted

Initial submission to the registry

October 10, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed

20 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed

8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed

Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

2.3 years

First QC Date

October 10, 2007

Results QC Date

August 17, 2020

Last Update Submit

September 23, 2020

Conditions

T-Cell Lymphoma B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Progression Free Survival (PFS)
Baseline to Measured Progressive Disease or Death From Any Cause (Up to 114 Months)
Time to Progressive (TTP) Disease
Baseline to Measured Progressive Disease (Up to 114 Months)
Duration of Response (DOR)
Baseline to Measured Progressive Disease (Up to 97 Months)
Percentage of Participants With Progression Free Survival (PFS) at 1-Year
Baseline to Measured Progressive Disease or Death From Any Cause (1 Year)
Number of Participants With One or More Drug-Related Adverse Events
Baseline to End of Study (Up to 114 Months)

Study Arms (3)

T-Cell

EXPERIMENTAL

T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days

Drug: enzastaurin

Indolent B-Cell

EXPERIMENTAL

Indolent B-Cell (IBCL): Small lymphocytic lymphoma, follicular lymphoma (Grade 1 or 2) and marginal zone lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days

Drug: enzastaurin

Aggressive B-Cell

EXPERIMENTAL

Aggressive B-Cell (ABCL): Primary central nervous system (CNS) lymphoma, follicular lymphoma (Grade 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma. Participants received enzastaurin 1125 mg loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days

Drug: enzastaurin

Interventions

enzastaurinDRUG

1125 mg loading dose then 500 mg, oral, daily until progressive disease

Also known as: LY317615

Aggressive B-CellIndolent B-CellT-Cell

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (14)

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, 92801, United States

Location

Garran, Australian Capital Territory, 2605, Australia

Location

Gosford, New South Wales, 2250, Australia

Location

Auchenflower, Queensland, 4066, Australia

Location

Prahran, Victoria, 3181, Australia

Location

Brasília, 70710-904, Brazil

Location

Curitiba, 81520-060, Brazil

Location

Jaú, 17210-120, Brazil

Location

Porto Alegre, 90430-090, Brazil

Location

São Paulo, 01323-903, Brazil

Location

Monterrey, 64460, Mexico

Location

Tepic, 63000, Mexico

Location

Tlalpan, 14080, Mexico

Location

Lima, LIMA13, Peru

Location

Related Publications (1)

Forsyth CJ, Gomez-Almaguer D, Camargo JF, Eliadis PE, Crespo-Solis E, Pereira J, Gutierrez-Aguirre CH, Rivas-Vera S, Roberson S, Lin B, Smith NV, Hamid O. A multicenter, open-label, noncomparative screening study of enzastaurin in adult patients with non-Hodgkin lymphomas. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):398-403. doi: 10.1016/j.clml.2013.03.005. Epub 2013 Jun 14.
PMID: 23770158DERIVED

MeSH Terms

Conditions

Lymphoma, T-CellLymphoma, B-Cell

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 12, 2007

Study Start

November 1, 2007

Primary Completion

March 1, 2010

Study Completion

February 27, 2018

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PE(1)ME(3)US(1)AU(4)BR(5)

A Study for Patients With Non-Hodgkin's Lymphomas

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

T-Cell

Indolent B-Cell

Aggressive B-Cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

T-Cell

Indolent B-Cell

Aggressive B-Cell

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (14)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations