Simple test may predict chemo risks for seniors with lymphoma
NCT ID NCT01829958
First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time
Summary
This study looks at whether a self-administered geriatric assessment can help predict serious side effects in people aged 60 and older with Non-Hodgkin lymphoma who are starting chemotherapy. The goal is to see if this assessment can identify who is at higher risk for hospitalization, dose reductions, or severe toxicity. The study also includes a small pilot test of a low-dose pre-treatment to see if it helps reduce side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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201 people
The number who actually took part.
- Started
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Apr 2013
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Other studies related to the condition(s) this trial covers.
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