Suspended

Self-Administered Geriatric Assessment for Toxicity Prediction in Older Non-Hodgkin Lymphoma Patients

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Study Aim

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.

What is being tested

rituximab

+ prednisone

+ Geriatric Assessment

DrugBehavioral
Who is being recruted

Hemic and Lymphatic Diseases+8

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: May 6, 2026
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorMemorial Sloan Kettering Cancer Center
Last updated: May 6, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellLymphoma, Non-HodgkinLymphoma, Large B-Cell, Diffuse

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
They will be treated with a single dose of rituximab 375mg/m2, once, by intravenous infusion 3-10 days prior to initiation of planned R-CHOP-like chemoimmunotherapy, and prednisone 50mg to 100 mg (preferred dose is 100mg) PO daily for 5-7 days (preferred duration is 7 days) of the 14 days prior to initiation of planned R-CHOP, R-EPOCH or R-CEPP chemoimmunotherapy. Pre-phase therapy may be given in either the inpatient or outpatient setting. After completion of a single course of pre-phase rituximab and prednisone as described above, further treatment will be according to the choice of the attending physician, in accordance with appropriate medical practice. It is expected, based on the inclusion criteria, that patients enrolled on the pre-phase arm will most often receive initial therapy consisting of R-CHOP, R-EPOCH or RCEPP chemoimmunotherapy for ≥ 2 cycles, but alternative therapies as deemed appropriate by the treating physician will not be considered violations of this protocol.

Group II

Experimental
Patients enrolled on the GA only arm of the study will be treated according to the choice of the attending physician. This arm of the study is non-therapeutic.

Study 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 Maps

Memorial Sloan Kettering Monmouth

Middletown, United States

Memorial Sloan Kettering Bergen

Montvale, United States

Memorial Sloan Kettering Commack

Commack, United States
Suspended8 Study Centers