An Study of Patients With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Patients Who Take R-CHOP Only - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00451178

Purpose

To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time measured in patients with intermediate and/or high risk DLBCL receiving first-line treatment.

Condition	Intervention	Phase
Lymphoma	Drug: enzastaurin Drug: rituximab Drug: cyclophosphamide Drug: doxorubicin Drug: vincristine Drug: prednisone	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-label, Randomized, Phase 2 Study of R-CHOP Plus Enzastaurin Versus R-CHOP in the First-Line Treatment of Patients With Intermediate and High-Risk Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Enzastaurin Rituximab Vincristine sulfate

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Progression Free Survival time [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare R-CHOP plus enzastaurin versus R-CHOP in terms of CR and/or CRu rate and ORR [ Time Frame: baseline, cycle 2, cycle 6 then quarterly, every 6 months ] [ Designated as safety issue: No ]
Compare R-CHOP plus enzastaurin versus R-CHOP in terms of 2-year Progression Free Survival rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
To evaluate PET-negative rate for each treatment arm [ Time Frame: baseline, cycle 6 ] [ Designated as safety issue: No ]
To investigate concordance between CT scan/MRI and PET scan [ Time Frame: baseline, cycle 6 ] [ Designated as safety issue: No ]
Event Free Survival [ Time Frame: baseline to objective progression, start of new therapy or death from any cause ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: baseline to death from any cause ] [ Designated as safety issue: Yes ]
Duration of complete response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
Assess biomarkers and their correlation to clinical outcomes [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]
Evaluate toxicity and tolerability of R-CHOP plus enzastaurin [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: enzastaurin 1125 mg then 500 mg, oral, daily, six 21 day cycles or up to 3 years Other Name: LY317615 Drug: rituximab 375 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: cyclophosphamide 750 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: doxorubicin 50 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: vincristine 1.4 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: prednisone 100 mg, oral, days 1-5, six 21 day cycles
Active Comparator: B	Drug: rituximab 375 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: cyclophosphamide 750 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: doxorubicin 50 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: vincristine 1.4 mg/m2, IV, day 1 every 21 days, six 21 day cycles Drug: prednisone 100 mg, oral, days 1-5, six 21 day cycles

Arms

Assigned Interventions

Experimental: A

Drug: enzastaurin

1125 mg then 500 mg, oral, daily, six 21 day cycles or up to 3 years

Other Name: LY317615

Drug: rituximab

375 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: cyclophosphamide

750 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: doxorubicin

50 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: vincristine

1.4 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: prednisone

100 mg, oral, days 1-5, six 21 day cycles

Active Comparator: B

Drug: rituximab

375 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: cyclophosphamide

750 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: doxorubicin

50 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: vincristine

1.4 mg/m2, IV, day 1 every 21 days, six 21 day cycles

Drug: prednisone

100 mg, oral, days 1-5, six 21 day cycles

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must:

Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the patient is entered. Patients with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.
Have received no prior chemotherapy.
Have an IPI score > or = to 2 at time of original diagnosis.
Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
Have adequate organ function as follows:
- Hepatic: total bilirubin < or = to 1.5 times the upper limit of normal (X ULN); alanine transaminase (ALT) and aspartate transaminase (AST) < or = to 1.5 X ULN, (≤5 X ULN, if liver involvement).
- Renal: serum creatinine < or = to 1.5 X ULN
- Adequate bone marrow reserve: platelets > or = to 75 X 10 to the ninth/L, absolute neutrophil count (ANC) > or = to 1.0 X 10 to the ninth/L, unless there is bone marrow involvement.
Exclusion Criteria:

Patients must not:
Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
Are receiving concurrent administration of any other systemic anticancer therapy.
Are pregnant or breastfeeding.
Are unable to swallow tablets.
Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451178

Show 25 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00451178 History of Changes
Other Study ID Numbers:	9824, H6Q-MC-S028
Study First Received:	March 21, 2007
Last Updated:	November 30, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Vincristine

Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012