Self-Administered Geriatric Assessment for Toxicity Prediction in Older Non-Hodgkin Lymphoma Patients
This study aims to assess the toxicity of chemotherapy treatment in older patients with Non-Hodgkin Lymphoma, using a self-administered geriatric assessment, to predict potential hospitalizations, dose reductions, delays or discontinuations, and high-grade non-hematologic or hematologic toxicity.
rituximab
+ prednisone
+ Geriatric Assessment
Hemic and Lymphatic Diseases+8
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.This study focuses on older patients, aged 60 and above, who are diagnosed with Non-Hodgkin Lymphoma (NHL) and are receiving chemotherapy or chemoimmunotherapy. The main goal is to test how well a self-administered geriatric assessment (GA) can predict potential side effects or complications from the treatment. This research is important as it aims to improve the care for older NHL patients by anticipating and managing treatment-related toxicity, enhancing their quality of life and treatment outcomes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.201 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Subjects meeting the following criteria will be eligible for enrollment in the study (unless excluded): * ≥60 years old * Pathologically confirmed NHL. * Must meet criteria for initiation of treatment; consisting of: * Aggressive histology, or * Indolent histology with one of the following markers of large tumor burden (67): * Any nodal or extranodal tumor mass ≥7cm in greatest dimension * ≥3 nodal masses that are each ≥3 cm in greatest dimension * Systemic symptoms * Cytopenias (leukocytes \<1 × 109/L and/or platelets ,100 × 109/L) * Substantial splenomegaly * Serous effusion (plural effusion or peritoneal ascites) * Orbital or epidural involvement * Ureteral compression * Leukemic phase (malignant cells ≥5 x 109/L) * Must be starting a new chemotherapy regimen (patients whose treatment regimen includes an immunomodulatory agent such as lenalidomide or small molecule targeted agents such as Ibrutinib or Idelelasib will be included in the study; patients being treated with a single agent monoclonal antibody will not be included). * Fluent in English (because not all components of the GA have been validated in other languages) * Able to provide informed consent In addition to the above, subjects meeting the following criteria will be enrolled in the pre-phase arm of the study, until the accrual target for that arm is reached: * Age ≥ 70 years OR KPS ≤ 70 * Pathologically confirmed diagnosis of DLBCL, with or without simultaneous or antecedent indolent lymphoma. * Previously untreated for DLBCL * Intended initial treatment to include ≥2 cycles of R-CHOP, R-EPOCH or R-CEPP using standard doses and schedule.(68, 69) R-CHOP chemoimmunotherapy may be given every 14 days or every 21 days. (4, 70) Exclusion Criteria: Subjects meeting the following criteria will be excluded from enrollment in the study: * Enrollment in a Phase I trial * Previously enrollment in this study * Patients scoring ≥ 11 on the BOMC (implying cognitive impairment) will be excluded since their ability to reliably complete the questionnaire will be in doubt Subjects meeting the following criteria will be excluded from enrollment in the pre-phase arm of the study, but may be included in the GA only arm. * Contraindication to use of rituximab or prednisone including: * Uncontrolled diabetes mellitus * Systemic fungal infection * Evidence of active hepatitis B infection (i.e. patients testing positive hepatitis B surface antigen or viral DNA by PCR analysis) will be excluded. Patients with evidence of past infection without active viremia (i.e. positive hepatitis B core antibody, negative hepatitis B surface antigen and negative hepatitis B DNA PCR) will be treated with entecavir as per institutional guidelines and may be included in the study. * History of any serious adverse reaction to either a corticosteroid or rituximab not including rituximab infusion reactions ≤ Grade 3. * Patients enrolled on another clinical trial which prohibits the use of pre-phase therapy or any of its components.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Memorial Sloan Kettering Basking Ridge
Basking Ridge, United StatesOpen Memorial Sloan Kettering Basking Ridge in Google MapsMemorial Sloan Kettering Monmouth
Middletown, United StatesMemorial Sloan Kettering Bergen
Montvale, United StatesMemorial Sloan Kettering Commack
Commack, United States