Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy

March 11, 2024 updated by: Memorial Sloan Kettering Cancer Center
This study will evaluate the ability of a largely self-administered geriatric assessment (GA) to predict toxicity in non-Hodgkin Lymphoma (NHL) patients ≥60 years old receiving chemotherapy or chemoimmunotherapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Rockville Centre
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-Phase Arm
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.
Drug: prednisone
Drug: rituximab
Behavioral: Geriatric Assessment
Experimental: Geriatric Assessment (GA) only arm
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.
Behavioral: Geriatric Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity Assessment
Time Frame: 3 years
Hospitalization during or within 30 days following chemotherapy Dose delay or reduction to a dose intensity ≤80% of the planned dose intensity. Dose reductions occurring prior to cycle 1 of chemotherapy will be counted as events. Discontinuation of chemotherapy due to toxicity Grade 3 or higher non-hematologic toxicity Grade 4 or higher hematologic toxicity. Using the NCI CTCAE v4.0 toxicity grading
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Paul Hamlin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimated)

April 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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