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A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01355783
Recruitment Status : Withdrawn
First Posted : May 18, 2011
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE May 16, 2011
First Posted Date  ICMJE May 18, 2011
Last Update Posted Date November 18, 2013
Study Start Date  ICMJE March 2011
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
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 ]
  • Pretreatment or pre-randomization (screening and baseline): 4 weeks.
  • Treatment: 18 weeks.
  • Follow up: 2 to 3 years after the end of study treatment. Treatment will stop upon disease progression, unacceptable toxicity, or death, whichever occurs first. The Investigator or subject may also stop study treatment at any time for safety or personal reasons; however subject should remain on study, if possible, for follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
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 ]
  • Pretreatment or pre-randomization (screening and baseline): 4 weeks.
  • Treatment: 18 weeks.
  • Follow up: 2 to 3 years after the end of study treatment. Treatment will stop upon disease progression, unacceptable toxicity, or death, whichever occurs first. The Investigator or subject may also stop study treatment at any time for safety or personal reasons; however subject should remain on study, if possible, for follow-up.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
Official Title  ICMJE A Phase 3 Trial of E7777 in Combination With CHOP Compared With CHOP Alone for the First-Line Treatment of Peripheral T-cell Lymphoma
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral T-Cell Lymphoma
Intervention  ICMJE Drug: E7777
Treatment in both arms is for 6 cycles at 21 days/cycle.
Study Arms  ICMJE
  • Active Comparator: E7777 + CHOP Chemotherapy
    Intervention: Drug: E7777
  • Active Comparator: CHOP alone
    Intervention: Drug: E7777
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 14, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2011)
352
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion:

Subjects must meet all of the following criteria to be included in the study:

  1. 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).
  2. Stage II, III or IV disease.
  3. 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.
  4. 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.
  5. Age ≥ 18 years.
  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  7. 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)
  8. 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)
  9. 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.
  10. Willing and able to comply with all aspects of the protocol.
  11. Written informed consent prior to any study-specific screening procedures.
  12. 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.
  13. 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:

  1. 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.
  2. Known central nervous system (CNS) involvement with lymphoma.
  3. 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).
  4. 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.
  5. Prior malignancy within past 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix).
  6. Serious intercurrent illness.
  7. 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).
  8. Left ventricular ejection fraction (LVEF) less than institutional lower limit of normal, as determined by multigated acquisition scan (MUGA) or echocardiogram.
  9. Major surgery within 2 weeks of study enrollment.
  10. Active infections requiring specific anti-infective therapy.
  11. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or hepatitis C infection.
  12. Deep vein thrombosis within 3 months of study enrollment.
  13. Females who are pregnant (positive urine test) or breastfeeding.
  14. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01355783
Other Study ID Numbers  ICMJE E7777-G000-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chean Eng Ooi Eisai Inc.
PRS Account Eisai Inc.
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP