Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
NCT ID: NCT02561273
Last Updated: 2023-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
54 participants
INTERVENTIONAL
2015-09-28
2020-11-01
Brief Summary
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Detailed Description
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I. To assess the safety and efficacy of lenalidomide in combination with standard induction therapy (CHOEP- cyclophosphamide, doxorubicin \[doxorubicin hydrochloride\], etoposide, vincristine \[vincristine sulfate\] and prednisone) in patients with newly diagnosed stage II, III and IV peripheral T-cell lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (anaplastic lymphoma receptor tyrosine kinase \[ALK\] negative) (ALK positive if International Prognostic Index \[IPI\] 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma or hepatosplenic gamma delta T-cell lymphoma.
II. To establish the maximum tolerated dose of lenalidomide in combination with CHOEP chemotherapy. (Phase I) III. To assess the efficacy (complete response rate) of this combination. (Phase II)
SECONDARY OBJECTIVES:
I. To evaluate overall response rate (complete response \[CR\] + partial response \[PR\]) of the combination of lenalidomide and CHOEP chemotherapy.
II. To evaluate the safety and tolerability of the regimen. III. To assess the 2 year progression free survival (PFS) and overall survival (OS) using this regimen.
OUTLINE: This is a phase I, dose-escalation study of lenalidomide, followed by a phase II study.
Patients receive cyclophosphamide intravenously (IV), doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone orally (PO) on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:
TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.
MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (combination chemotherapy, lenalidomide)
Patients receive cyclophosphamide IV, doxorubicin hydrochloride IV and vincristine sulfate IV on day 1, etoposide IV over 30-60 minutes on days 1-3, prednisone PO on days 1-5, and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients responding after 6 courses of treatment may then undergo an autologous stem cell transplant or receive maintenance lenalidomide at the discretion of the physician or patient choice as follows:
TRANSPLANT: Patients undergo autologous stem cell transplant per standard of care.
MAINTENANCE LENALIDOMIDE: Patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous stem cell transplant
Cyclophosphamide
Given IV
Doxorubicin Hydrochloride
Given IV
Etoposide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Peripheral Blood Stem Cell Transplantation
Undergo peripheral blood stem cell transplant
Prednisone
Given PO
Vincristine Sulfate
Given IV
Interventions
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Autologous Hematopoietic Stem Cell Transplantation
Undergo autologous stem cell transplant
Cyclophosphamide
Given IV
Doxorubicin Hydrochloride
Given IV
Etoposide
Given IV
Laboratory Biomarker Analysis
Correlative studies
Lenalidomide
Given PO
Peripheral Blood Stem Cell Transplantation
Undergo peripheral blood stem cell transplant
Prednisone
Given PO
Vincristine Sulfate
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathology material: hematoxylin and eosin (H\&E) stain and immunohistochemistry (IHC) slides or a representative formalin-fixed paraffin-embedded (FFPE) tissue block along with the pathology report from initial diagnosis, should be sent to be reviewed, and the diagnosis confirmed by Mayo Clinic department (retrospective diagnostic review: treatment may commence prior to the Mayo Clinic review)
* No prior therapy with the exception of prior radiation therapy and/or prednisone alone, at the discretion of the investigator based on current diagnosis and clinical condition; this prednisone treatment will not count toward the 6 cycles of treatment given in the study
* Expected survival duration of \> 3 months
* Karnofsky performance status \> 70
* Absolute neutrophil count (ANC) \> 1000 cells/mm\^3, unless cytopenias due to non-Hodgkin lymphoma (NHL) (i.e., bone marrow involvement or splenomegaly)
* Platelet count \> 100,000/uL or \> 75,000/uL if bone marrow (BM) involvement or splenomegaly
* Total bilirubin =\< 1.5 x upper normal limit, or =\< 3 x upper normal limit if documented hepatic involvement with lymphoma, or =\< 5 x upper normal limit if history of Gilbert's disease
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper normal limit (=\< 5 x upper normal limit if documented hepatic involvement with lymphoma)
* Serum creatinine \< 2.0 mg/dL or calculated creatinine clearance (CrCl) \> 45 mL/min (Cockcroft-Gault)
* Prothrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =\< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic range
* If currently not on anticoagulation medication, willing and able to take aspirin (81 or 325 mg) daily; if aspirin is contraindicated, the patient may be considered for the study if on therapeutic dose warfarin or low molecular weight heparin; patients unable to take any prophylaxis are not eligible
* 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)/computed tomography (CT) scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
* Patients with measurable disease must have at least one objective measurable disease parameter; a clearly defined, bi-dimensionally measurable defect or mass measuring at least 1.5 cm in diameter on the CT portion of a PET/CT or CT scan or magnetic resonance imaging (MRI) (if appropriate) will constitute measurable disease; proof of lymphoma in the liver is required by a confirmation biopsy; skin lesions can be used as measurable disease provided bi-dimensional measurements are possible
* All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS) program, and be willing and able to comply with the requirements of the REMS program
* Women must not be pregnant or breast-feeding
* Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program
* 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 as noted above; 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, or antiviral drugs
* 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
* Known hypersensitivity to thalidomide or lenalidomide
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or similar drugs
* Ejection fraction of \< 45% by either multi gated acquisition scan (MUGA) or echocardiogram (ECHO)
Exclusion Criteria
* Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive ( i.e. hepatitis B core antibody positive; quantitative deoxyribonucleic acid \[DNA\] negative) are eligible with appropriate prophylaxis
* 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
University of Nebraska
OTHER
Responsible Party
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Principal Investigators
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Matthew A Lunning
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
University of Colorado Cancer Center, Anschutz Cancer Pavilion
Aurora, Colorado, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2015-00088
Identifier Type: REGISTRY
Identifier Source: secondary_id
RV-CL-PTCL-PI-003858
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0511-14-FB
Identifier Type: -
Identifier Source: org_study_id