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

Sponsored by:	Eli Lilly and Company
Information provided by:	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

MedlinePlus related topics: Lymphoma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: enzastaurin 1125 mg then 500 mg, oral, daily, six 21 day cycles or up to 3 years 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
B: Active Comparator	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

A: Experimental

Drug: enzastaurin

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

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

B: Active Comparator

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

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 31 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 ( Chief Medical Officer )
Study ID Numbers:	9824, H6Q-MC-S028
Study First Received:	March 21, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00451178 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Hormones
Lymphoma, B-Cell
Anti-Bacterial Agents
Lymphoma, Large-cell
Lymphoma
Alkylating Agents
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders

Antineoplastic Agents, Hormonal
Rituximab
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Lymphatic Diseases
B-cell Lymphomas
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type

Antineoplastic Agents, Hormonal
Immune System Diseases
Mitosis Modulators
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009