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A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

Primary Purpose

Peripheral T-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ontak
CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral T-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pathological diagnosis of peripheral T-cell lymphoma of one of following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma. Treatment naive except for prior radiation or a single cycle of CHOP. Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography. Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within 4 weeks prior to registration to this study. Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Age > 18 years old. Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) ≥ 1000/mm³, platelets ≥50,000/mm³(25,000/mm³ if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin ≥8 g/dL. These values must be obtained within 2 weeks before protocol entry. Adequate liver function, indicated by bilirubin ≤1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) ≤2 times the ULN or aspartate transaminase (AST) ≤2.0 times the ULN and albumin > 3.0 g/dl. Adequate renal function, indicated by serum creatinine ≤2.5 mg/dL. Laboratory values must be obtained within 2 weeks before study entry. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. Able to give informed consent. Exclusion Criteria: Patients with diagnosis of Mycosis Fungoides or Sezary Syndrome Patients with active Hepatitis B or Hepatitis C infection. Patients with known HIV infection are excluded. These patients are excluded because the potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy. HIV testing is not required. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved and any continuing treatment is given on an outpatient basis. Patients with previous anthracycline therapy (cumulative dose of > 100 mg/m2). Patients with Left Ventricular Ejection Fraction (LVEF) < 50%. Patients who are pregnant or breast-feeding. These patients are excluded because the effects of this treatment on the fetus and young children are unknown. Prior invasive malignancies within past 5 years. Allergic to or history of allergy to diphtheria toxin or IL-2. Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within past 3 months, arrhythmia) requiring ongoing treatment. Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days. Patients with deep vein thrombosis within 3 months.

Sites / Locations

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

Outcomes

Primary Outcome Measures

Number of Patients That Achieved a Complete Response or a Partial Response (PR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Number of Patients That Achieved a Complete Response (CR)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Secondary Outcome Measures

Full Information

First Posted
June 15, 2006
Last Updated
February 9, 2015
Sponsor
Yale University
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00337987
Brief Title
A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
Official Title
A Pilot Phase II Study to Determine the Safety of the Combination of ONTAK (DAB389IL-2), an Interleukin-2 Fusion Toxin, in Combination With CHOP in Peripheral T-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
The standard treatment for PTCL is CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy. This study is attempting to determine whether adding other treatments to CHOP therapy will improve the chance of the disease going into remission or staying in remission. Because other drugs for T-cell lymphoma have not yet been given with CHOP, this study is looking at combining CHOP with ONTAK. ONTAK has been FDA approved for treatment of Cutaneous T cell Lymphoma and works by specifically binding to a protein on the surface of the tumor cells and killing the cell without causing damage to other types of cells in the body. Studies have shown that ONTAK has helped patients with PTCL who have failed chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ontak
Other Intervention Name(s)
DAB 389 IL-2
Intervention Description
ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
Intervention Type
Drug
Intervention Name(s)
CHOP (cyclophosphamide (C), adriamycin (H), vincristine (O), and prednisone (P)) chemotherapy
Intervention Description
ONTAK ( denileukin diftitox) is given at 18 mcg/kg/d (Days 1,2) plus CHOP therapy (Day 3) q 21 days x 6 cycles (cyclophosphamide 750 mg/m²IV, doxorubicin 50 mg/m²IV day, vincristine 1.4 mg/m²IV day, and prednisone 100 mg q day PO days #3-7) plus, G-CSF support beginning on Day 4 to prevent neutropenia
Primary Outcome Measure Information:
Title
Number of Patients That Achieved a Complete Response or a Partial Response (PR)
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
After 4 years
Title
Number of Patients That Achieved a Complete Response (CR)
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time Frame
After 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathological diagnosis of peripheral T-cell lymphoma of one of following histologies as per the REAL classification: peripheral T-cell lymphoma (unspecified), anaplastic large cell lymphoma CD30+, angioimmunoblastic T-cell lymphoma, nasal/nasal type T/NK cell lymphoma, intestinal T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma. Treatment naive except for prior radiation or a single cycle of CHOP. Patients must have at least one clear-cut bidimensionally measurable site by physical exam and/or computed tomography. Baseline measurements of measurable sites and evaluation of evaluable disease must be obtained within 4 weeks prior to registration to this study. Prior radiation therapy for localized disease is allowed as long as the irradiated area is not at the mediastinal area or at the only site of measurable disease. Therapy must be completed at least 4 weeks before the enrollment in study. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Age > 18 years old. Adequate bone marrow reserve, indicated by absolute neutrophil count (ANC) ≥ 1000/mm³, platelets ≥50,000/mm³(25,000/mm³ if thrombocytopenia secondary to bone marrow involvement by lymphoma), and hemoglobin ≥8 g/dL. These values must be obtained within 2 weeks before protocol entry. Adequate liver function, indicated by bilirubin ≤1.5 times the upper limit of normal (ULN), alanine transaminase (ALT) ≤2 times the ULN or aspartate transaminase (AST) ≤2.0 times the ULN and albumin > 3.0 g/dl. Adequate renal function, indicated by serum creatinine ≤2.5 mg/dL. Laboratory values must be obtained within 2 weeks before study entry. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. Able to give informed consent. Exclusion Criteria: Patients with diagnosis of Mycosis Fungoides or Sezary Syndrome Patients with active Hepatitis B or Hepatitis C infection. Patients with known HIV infection are excluded. These patients are excluded because the potential to target activated T-cells, in a population of patients already at risk for T-cell depletion, would be a contraindication to therapy. HIV testing is not required. Patients with active infections requiring specific anti-infective therapy are not eligible until all signs of infections are resolved and any continuing treatment is given on an outpatient basis. Patients with previous anthracycline therapy (cumulative dose of > 100 mg/m2). Patients with Left Ventricular Ejection Fraction (LVEF) < 50%. Patients who are pregnant or breast-feeding. These patients are excluded because the effects of this treatment on the fetus and young children are unknown. Prior invasive malignancies within past 5 years. Allergic to or history of allergy to diphtheria toxin or IL-2. Preexisting severe cardiovascular disease (e.g. CHF, Severe CAD, cardiomyopathy, MI within past 3 months, arrhythmia) requiring ongoing treatment. Ongoing antineoplastic chemotherapy, radiation, hormonal (excluding contraceptives) or immunotherapy, or investigational medications within past 30 days. Patients with deep vein thrombosis within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francine Foss, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Comprehensive Cancer Center at Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma

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