CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Cyclophosphamide +8 moredrug
Likely dose
Lenalidomide dose not specified in INTERVENTIONS or ARMS; CHOEP regimen components listed without dosesAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed new diagnosis of stage II, III or IV peripheral T-cell NHL, including NOS, ALK-negative ALCL, ALK-positive ALCL (if IPI 3-5), angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, or hepatosplenic gamma-delta T-cell lymphoma
  • ✓No prior systemic therapy except radiation therapy and/or prednisone monotherapy at investigator discretion
  • ✓Expected survival >3 months
  • ✓Measurable or evaluable disease documented within 6 weeks of registration
Key exclusion· 8
  • ✕Pregnant or breast-feeding females
  • ✕Active or seropositive HIV, HBV, or HCV (except HBsAg-negative/anti-HBc-positive with appropriate prophylaxis)
  • ✕Prior malignancies within past 3 years except basal/squamous cell skin cancer, thyroid cancer, cervical/breast carcinoma in situ, or prostate cancer Gleason ≤6 with stable PSA
  • ✕PTCL histologies other than those specified in inclusion criteria

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02561273
NCT02561273Phase 2Completed
CompareCT.gov

A Phase I/II Trial of CHOEP Chemotherapy Plus Lenalidomide as Front Line Therapy for Patients With Stage II, III and IV Peripheral T-Cell Non-Hodgkin's Lymphoma

University of Nebraska·interventional·Posted Sep 28, 2015·Updated Dec 13, 2023

In Brief

A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and 7 other interventions for Anaplastic Large Cell Lymphoma, ALK-Negative and 9 related conditions. Completed, enrolled 54 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnaplastic 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, Stage II Enteropathy-Associated T-Cell Lymphoma, Stage III Angioimmunoblastic T-cell Lymphoma, Stage III Enteropathy-Associated T-Cell Lymphoma, Stage IV Angioimmunoblastic T-cell Lymphoma, Stage IV Enteropathy-Associated T-Cell Lymphoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 28, 2015
Enrollment StartSep 28, 2015
Primary CompletionNov 1, 2019
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.8 years ago

Interventions

Autologous Hematopoietic Stem Cell Transplantationprocedure

Undergo autologous stem cell transplant

Cyclophosphamidedrug

Given IV

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO

Peripheral Blood Stem Cell Transplantationprocedure

Undergo peripheral blood stem cell transplant

Prednisonedrug

Given PO

Vincristine Sulfatedrug

Given IV