- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00337987
A Pilot Study to Determine the Safety of the Combination of Ontak in Combination With CHOP in Peripheral T-Cell Lymphoma
February 9, 2015 updated by: Yale University
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
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
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients That Achieved a Complete Response or a Partial Response (PR)
Time Frame: After 4 years
|
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
|
After 4 years
|
Number of Patients That Achieved a Complete Response (CR)
Time Frame: After 4 years
|
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
|
After 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
November 1, 2005
Primary Completion (ACTUAL)
December 1, 2007
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
June 15, 2006
First Submitted That Met QC Criteria
June 15, 2006
First Posted (ESTIMATE)
June 20, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
February 27, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Prednisone
- Doxorubicin
- Liposomal doxorubicin
- Vincristine
- Denileukin diftitox
Other Study ID Numbers
- 0507000369
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.
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