Combination Chemotherapy and Pralatrexate as First-Line Therapy in Treating Patients With Non-Hodgkin Lymphoma
NCT ID: NCT01336933
Last Updated: 2023-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
34 participants
INTERVENTIONAL
2011-07-06
2016-12-28
Brief Summary
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Detailed Description
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I. To evaluate in a Phase II study a preliminary estimate of the complete response (CR) rate of a new chemotherapy regimen involving Cyclophosphamide, Etoposide, Vincristine and Prednisone (CEOP) alternating with Pralatrexate (P) as front line therapy for patients with Stage II, III and IV Peripheral T-Cell NHL not otherwise specified (NOS), Anaplastic large cell lymphoma (ALK negative), Angioimmunoblastic T-cell lymphoma, Enteropathy associated T-cell lymphoma, Hepatosplenic gamma delta T-cell lymphoma followed by an optional stem cell transplant with high dose chemotherapy and Autologous stem cell transplant.
SECONDARY OBJECTIVES:
I. To evaluate partial response (PR). II. To evaluate overall response (CR+PR). III. To evaluate the safety and tolerability of the regimen IV. To assess the 2 year event free survival (EFS) and overall survival (OS) using this regimen.
V. To assess the percentage of patients who proceeded with transplant. VI. To evaluate the ability to collect peripheral blood stem cells after this regimen.
OUTLINE:
Patients receive cyclophosphamide intravenously (IV) and vincristine IV on day 1, etoposide IV on days 1-3 or orally (PO) once daily (QD) on days 2-3, and prednisone PO QD on days 1-5 (CEOP administration). Patients also receive pralatrexate IV over 3-5 minutes on days 15, 22, and 29 (P administration). Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with Complete Response (CR) or Partial Response (PR), per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.
After completion of study treatment, patients are followed up for 2 years (transplant patients) or periodically.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
"A" Treatment: Cyclophosphamide,Etoposide, Vincristine and Prednisone (CEOP) "B" Treatment: Pralatrexate (P)
"A" cycles (CEOP) of the treatment regimen are 14 days, followed by " B" cycles (P) which are 21 days, followed by 7 days of rest for a total of 42 days per course, unless criteria are met for stopping or holding treatment or to a maximum of 6 courses.
Patients with Complete Response (CR) or Partial Response (PR), per investigators discretion, may then undergo hematopoietic stem cell collection and administration of standard preparative regimen followed by hematopoietic stem cell transplantation.
prednisone
Given PO
cyclophosphamide
Given IV
etoposide
Given PO or IV
Vincristine
Given IV
pralatrexate
Given IV
laboratory biomarker analysis
Correlative studies
comparative genomic hybridization
Correlative studies
gene expression analysis
Correlative studies
nucleic acid sequencing
Correlative studies
mutation analysis
Correlative studies
immunohistochemistry staining method
Correlative studies
microarray analysis
Correlative studies
RNA analysis
Correlative studies
Interventions
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prednisone
Given PO
cyclophosphamide
Given IV
etoposide
Given PO or IV
Vincristine
Given IV
pralatrexate
Given IV
laboratory biomarker analysis
Correlative studies
comparative genomic hybridization
Correlative studies
gene expression analysis
Correlative studies
nucleic acid sequencing
Correlative studies
mutation analysis
Correlative studies
immunohistochemistry staining method
Correlative studies
microarray analysis
Correlative studies
RNA analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathology material (hematoxylin and eosin \[H\&E\] stain, immunohistochemistry \[IHC\] and pathology report from initial diagnosis, if slides are not available, then 8 unstained slides of 4 micron thickness or a representative block should be sent) will be reviewed, and the diagnosis confirmed by University Nebraska Medical Center (UNMC) pathology department (retrospective diagnostic review: treatment may commence prior to the UNMC review)
* No prior therapy with the exception of prior radiation therapy and 1 cycle of chemotherapy based on current diagnosis and clinical condition
* Age 19 years or older (the age of consent in Nebraska); age 18 years or older (applicable to states where the age of majority is 18)
* Expected survival duration of \>= six months
* Karnofsky Performance Status \>= 70
* Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3, unless due to lymphoma involvement of the bone marrow
* Platelet Count \>= 100 mm\^3, unless due to lymphoma involvement of the bone marrow
* Total bilirubin =\< 1.5 x upper normal limit (ULN), or =\< 3 x ULN if documented hepatic involvement with lymphoma, or =\< 5 x ULN if history of Gilbert's Disease
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN (=\< 5 x ULN if documented hepatic involvement with lymphoma)
* Serum potassium within normal range
* Serum creatinine \< 2.0 mg/dL or calculated creatinine clearance (CrCl) \> 45 mL/min
* Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =\< 1.5 x ULN unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic range
* Patients with measurable disease; patients with non-measurable but evaluable disease may be eligible after discussion with the principal investigator (PI); baseline measurements and evaluations must be obtained within 6 weeks of registration to the study; abnormal positron emission tomography (PET) scans will not constitute evaluable disease, unless verified by computed tomography (CT) scan or other appropriate imaging
* Patients with measurable disease must have at least one objective measurable disease parameter; a clearly defined, bidimensionally measurable defect or mass measuring at least 2 cm in diameter on a CT scan will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy
* Women must not be pregnant or breast-feeding due to teratogenic effects of chemotherapy
* All females of childbearing potential must have a blood test within 2 weeks prior to registration to rule out pregnancy
* Pregnancy testing is not required for post-menopausal or surgically sterilized women
* Male and female patients of reproductive potential must agree follow accepted birth control measures
* Patient must be able to adhere to the study visit schedule and other protocol requirements
* Patients must be willing to give written informed consent, and sign an institutionally approved consent form before performance of any study-related procedure not part of normal medical care; with the exception of 1 cycle of chemotherapy based on current diagnosis and clinical condition, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
* No serious disease or condition that, in the opinion of the investigator, would compromise the patient's ability to participate in the study
* Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
* Any other clinically significant medical disease or condition laboratory abnormality or psychiatric illness that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
* Concomitant administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and trimethoprim/sulfamethoxazole will not be allowed, since these may result in delayed clearance of pralatrexate
Exclusion Criteria
* Known positive for human immunodeficiency virus (HIV), human T-lymphotropic virus type 1 (HTLV-1), or infectious hepatitis, type A, B or C or active hepatitis
* Major surgery within 2 weeks of study drug administration
* Prior malignancies within the past 3 years with exception of adequately treated basal cell, squamous cell skin cancer, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen (PSA) levels
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Spectrum Pharmaceuticals, Inc
INDUSTRY
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Julie M Vose
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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Mayo Clinic, Arizona
Scottsdale, Arizona, United States
Stanford University
Stanford, California, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Siteman Cancer Center, Washington University
St Louis, Missouri, United States
Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Countries
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References
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Advani RH, Ansell SM, Lechowicz MJ, Beaven AW, Loberiza F, Carson KR, Evens AM, Foss F, Horwitz S, Pro B, Pinter-Brown LC, Smith SM, Shustov AR, Savage KJ, Vose JM. A phase II study of cyclophosphamide, etoposide, vincristine and prednisone (CEOP) Alternating with Pralatrexate (P) as front line therapy for patients with peripheral T-cell lymphoma (PTCL): final results from the T- cell consortium trial. Br J Haematol. 2016 Feb;172(4):535-44. doi: 10.1111/bjh.13855. Epub 2015 Dec 2.
Other Identifiers
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NCI-2011-00254
Identifier Type: REGISTRY
Identifier Source: secondary_id
0569-10-FB
Identifier Type: -
Identifier Source: org_study_id
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