Status:
COMPLETED
Phase 1 Trial of Siplizumab and Dose-Adjusted EPOCH-Rituximab in T- and NK-Cell Lymphomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
T-Cell Peripheral Lymphoma
Gamma Delta Hepatosplenic T-Cell Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs may be more effective if given by continuous infusion into the vein rather than by the standard method of rap...
Detailed Description
Background: The clinical outcome for patients with T-cell non-Hodgkin's lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin's lymphoma. In most reports less than 20%...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Cluster of differentiation 2 (CD2)-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI). At least 30% of the malignant cells must be CD2 positive for inclusion in this study.
- Patients with chemotherapy naive T \& Natural Killer (NK) lymphomas, including but not limited to peripheral T cell lymphoma (nos), gamma-delta hepatosplenic T cell lymphoma, subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with alk-positive anaplastic large cell lymphoma and patients with T-cell precursor disease are not eligible.
- Age greater than or equal to 18 years.
- Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's (unconjugated hyperbilirubinemia without other known cause), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times upper limit of normal (ULN) (AST and ALT less than or equal to 6 times ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) and; Absolute neutrophil count (ANC) greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ impairment by tumor.
- No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year.
- Patients must not have a marked baseline prolongation of Q wave, T wave (QT/QTc) interval (e.g., demonstration of a corrected QT interval (QTc) interval \>500 milliseconds (ms)).
- Human immunodeficiency virus (HIV) negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression.
- Signed informed consent by the patient or patient's representative.
- Willing to use contraception.
- Not pregnant or nursing, because of the unknown effects of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) or siplizumab on the developing fetus and infant.
- No serious underlying medical condition or infection that would contraindicate treatment. Patients with central nervous system (CNS) involvement are eligible for treatment on this study.
- EXCLUSION CRITERIA:
- Patients less than 18 years of age will be excluded because siplizumab has not been given to minors in combination with chemotherapy.
Exclusion
Key Trial Info
Start Date :
January 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01445535
Start Date
January 13 2009
End Date
October 22 2020
Last Update
November 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892