Phase 2
N=44
Combination Chemotherapy & Lenalidomide in Newly Diagnosed Stage II-IV Peripheral T-cell Non-Hodgkin's Lymphoma
Anaplastic Large Cell Lymphoma, ALK-Negative · Anaplastic Large Cell Lymphoma, ALK-Positive · Hepatosplenic T-Cell Lymphoma · Peripheral T-Cell Lymphoma, Not Otherwise Specified · Stage II Angioimmunoblastic T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02561273 ↗Enrolled (actual)
44
Serious AEs
37.2%
Results posted
Jun 2021
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP — 10 milligrams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Hematopoietic Stem Cell Transplantation (Procedure); Cyclophosphamide (Drug); Doxorubicin Hydrochloride (Drug); Etoposide (Drug); Laboratory Biomarker Analysis (Other); Lenalidomide (Drug); Peripheral Blood Stem Cell Transplantation (Procedure); Prednisone (Drug); Vincristine Sulfate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Nebraska
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Lenalidomide and CHOEP |
10 | — |
| PRIMARY Number of Participants With Adverse Events Graded According to Common Toxicity Criteria (CTC) (Phase I) |
5; 4; 3; 3; 2; 3 | — |
| PRIMARY Complete Response Rate (Phase II) |
49 | — |
| PRIMARY Overall Response Rate |
69 | — |
| SECONDARY Number of Participants With Adverse Events Graded According to CTC (Phase II) |
27; 25; 17; 17; 18; 15 | — |
| SECONDARY Overall Survival |
89 | — |
| SECONDARY Progression-free Survival |
55 | — |
Summary
This phase I/II trial studies the side effects and best dose of lenalidomide when given together with combination chemotherapy and to see how well they work in treating patients with newly diagnosed stage II-IV peripheral T-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of peripheral T-cell non-Hodgkin's lymphoma by blocking the growth of new blood vessels necessary for cancer growth. Giving combination chemotherapy with lenalidomide may be a better treatment for peripheral T-cell non-Hodgkin's lymphoma.
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed new diagnosis of stage II, III and IV peripheral T-cell non-Hodgkin's lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (ALK negative) (ALK positive if IPI 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma
- 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 = 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
Data sourced from ClinicalTrials.gov (NCT02561273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.