- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01355783
A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
November 14, 2013 updated by: Eisai Inc.
The purpose of this study is to evaluate whether treatment of E7777 in combination with CHOP has superior efficacy compared with CHOP alone in improving complete response rate (CRR) in first line treatment of subjects with Peripheral T-cell Lymphoma (PTCL).
Study Overview
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Skokie, Illinois, United States
-
-
New Jersey
-
Morristown, New Jersey, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion:
Subjects must meet all of the following criteria to be included in the study:
- Local pathologic diagnosis of PTCL with the following histology types: PTCL, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large cell lymphoma (ALCL) (ALK-negative or ALKpositive with IPI ≥ 2).
- Stage II, III or IV disease.
- Tumor lesion(s) measurable in 2 dimensions by computed tomography (CT) and is at least 20 mm in the longest transverse dimension for non-lymph node masses and at least 20 mm in longest transverse dimension for lymph nodes. Subcutaneous masses can be used as indicator lesions. If the lesion was previously irradiated, it must have progressed prior to randomization (by investigator assessment) to be used as a measurable lesion.
- Tumor biopsy available for central pathologic review; may be archived sample from prior biopsy within 6 months of study enrollment, or sample to be obtained on study during screening.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate bone marrow reserve as evidenced by:
- absolute neutrophil count (ANC) ≥ 1000/mm3 (1.0x109/L)
- platelets ≥ 50,000/mm3 (50x109/L); (≥ 25,000/mm3 [25x109/L] allowed if thrombocytopenia secondary to bone marrow involvement by lymphoma)
- hemoglobin ≥ 8 g/dL (80 g/L)
Adequate liver function as evidenced by:
- bilirubin ≤ 1.5 times the upper limit of normal (ULN)
- aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤ 3 times the ULN (≤ 5 times the ULN if hepatic involvement)
- albumin ≥ 3.0 g/dL (30 g/L)
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL (176 μmol/L) or calculated creatinine clearance ≥ 40 mL/min per the Cockcroft-Gault formula.
- Willing and able to comply with all aspects of the protocol.
- Written informed consent prior to any study-specific screening procedures.
- Female subjects of childbearing potential must have a negative serum betahuman chorionic gonadotropin (β-hCG) pregnancy test at Screening and a negative serum or urine β-hCG pregnancy test result at Baseline, and must agree to use a highly effective method of contraception (see protocol for list) throughout the entire study period and for 30 days after study drug discontinuation.
- Male subjects who are partners of women of childbearing potential must use or their partners must use a highly effective method of contraception (see protocol for list) beginning at least 1 menstrual cycle prior to starting study drug(s),throughout the entire study period, and for 30 days after study drug discontinuation, unless they are sexually abstinent or have undergone a successful vasectomy. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception, as described previously.
Exclusion:
Subjects who meet any of the following criteria will be excluded from the study:
- Diagnosis of ALCL ALK-positive with IPI 0 or 1, adult T-cell leukemia/lymphoma (ATLL), precursor T-cell lymphoblastic lymphoma/leukemia, extranodal NK/TCL nasal type, enteropathy-associated TCL, hepatosplenic TCL, subcutaneous panniculitis-like TCL, and cutaneous T-cell lymphoma (CTCL) including mycosis fungoides and Sezary syndrome.
- Known central nervous system (CNS) involvement with lymphoma.
- Prior chemotherapy, immunotherapy, denileukin diftitox, or investigational agent(s) for this lymphoma, with the exception that a single cycle of CHOP (or CHOP-based therapy) is allowed if the last dose of CHOP (or CHOP-based therapy) was administered ≤ 28 days before study enrollment (Lead-In) or randomization (Main Study).
- Prior radiotherapy for this lymphoma, with the following exception: prior radiation therapy for localized disease ≥ 4 weeks before randomization is allowed as long as the irradiated area is not at the mediastinal area or at the site of the only potentially measurable disease.
- Prior malignancy within past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
- Serious intercurrent illness.
- Significant cardiac disease requiring ongoing treatment, including congestive heart failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI) (within 6 months of study enrollment).
- Left ventricular ejection fraction (LVEF) less than institutional lower limit of normal, as determined by multigated acquisition scan (MUGA) or echocardiogram.
- Major surgery within 2 weeks of study enrollment.
- Active infections requiring specific anti-infective therapy.
- Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection.
- Deep vein thrombosis within 3 months of study enrollment.
- Females who are pregnant (positive urine test) or breastfeeding.
- Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E7777 + CHOP Chemotherapy
|
Treatment in both arms is for 6 cycles at 21 days/cycle.
|
Active Comparator: CHOP alone
|
Treatment in both arms is for 6 cycles at 21 days/cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate whether treatment of E7777 in combination with CHOP chemotherapy has superior efficacy compared with CHOP alone in improving progression-free survival (PFS) in first line treatment of subjects with peripheral T-cell lymphoma
Time Frame: pre-randomization 4 weeks until disease progression
|
|
pre-randomization 4 weeks until disease progression
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate whether E7777 in combination with CHOP treatment has superior efficacy compared with CHOP treatment alone as assessed by overall survival (OS) and by transplant rate.· To compare safety of E7777 in combination with CHOP
Time Frame: pre-randomization 4 weeks until disease progression
|
|
pre-randomization 4 weeks until disease progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chean Eng Ooi, Eisai Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
May 16, 2011
First Submitted That Met QC Criteria
May 17, 2011
First Posted (Estimate)
May 18, 2011
Study Record Updates
Last Update Posted (Estimate)
November 18, 2013
Last Update Submitted That Met QC Criteria
November 14, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7777-G000-301
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral T-Cell Lymphoma
-
The First Affiliated Hospital of Xiamen UniversityThe First Affiliated Hospital with Nanjing Medical University; Shanxi Province... and other collaboratorsRecruitingPeripheral T Cell Lymphoma | Relapsed Peripheral T-Cell Lymphoma | Refractory T-Cell LymphomaChina
-
National Cancer Centre, SingaporeMerck Sharp & Dohme LLC; National Medical Research Council (NMRC), SingaporeNot yet recruitingRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaSingapore
-
The Lymphoma Academic Research OrganisationCompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaFrance, Belgium
-
Millennium Pharmaceuticals, Inc.CompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaUnited States, France, Italy, Poland, United Kingdom, Belgium, Germany, Spain, Belarus, Israel, Portugal, Bulgaria, Turkey, Canada, New Zealand, Peru, Brazil, Russian Federation, Chile, Puerto Rico, Australia, Austria, Hungary, Nether... and more
-
University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
-
Karyopharm Therapeutics IncTerminatedCutaneous T-cell Lymphoma (CTCL) | Peripheral T-cell Lymphoma (PTCL)Australia, Singapore
-
BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingAngioimmunoblastic T-cell Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma | Follicular T-Cell Lymphoma | Nodal Peripheral T-Cell Lymphoma...United States
-
OnxeoTerminatedNon-Hodgkin's Lymphoma | Cutaneous T-Cell Lymphoma | Peripheral T-Cell LymphomaUnited States, Germany, Israel, France, Thailand
Clinical Trials on E7777
-
Eisai Co., Ltd.CompletedCutaneous T-cell Lymphoma | Peripheral T-cell LymphomaJapan
-
Eisai Inc.Dr. Reddy's Laboratory; Citius PharmaceuticalsCompletedPersistent or Recurrent Cutaneous T-Cell LymphomaUnited States, Australia, Puerto Rico
-
Masonic Cancer Center, University of MinnesotaRecruitingDiffuse Large B Cell Lymphoma | DLBCL | High-grade B-cell Lymphoma | DLBCL Arising From Follicular LymphomaUnited States
-
Eisai Co., Ltd.CompletedPeripheral T-Cell LymphomaJapan
-
Haider MahdiDr. Reddys Laboratories, SARecruitingEpithelial Ovarian CancerUnited States