Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lym… (NCT01829958) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comprehensive Geriatric Assessment to Predict Toxic Events in Older Patients With Non-Hodgkin Lymphoma With Imbedded Pilot Study of Pre-Phase Therapy
United States201 participantsStarted 2013-04
Plain-language summary
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.
Who can participate
Age range60 Years
SexALL
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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 l…