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 range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.