A Phase 2 interventional study of Best Practice and Cognitive Intervention in B-Cell Non-Hodgkin Lymphoma and Multiple Myeloma, sponsored by City of Hope Medical Center. Recruiting at 4 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Supportive care
Among 398 studies in Lymphoma, B-Cell with a site in United States — 91 open to participants now, 159 under way, 12 of them phase 3. Lymphoma, B-Cell · United States.
Among the 398 studies in Lymphoma, B-Cell with a site in United States, this one is the 48th largest by planned enrollment of the 380 interventional ones, is one of 36 that started in 2023, is one of 112 in phase 2, reaches primary completion later than 84 of the 158 other live ones, and was the 340th registered.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 164 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →91 of the 398 studies in Lymphoma, B-Cell with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 209 Lymphoma, B-Cell studies recruiting now, 129 (62%) set no upper age limit and 60 (29%) stop at 75 or younger; 37 take children under 18; 3 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →398 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 36 started in 2023.
Median enrollment 37 across the 380 interventional studies, 150 across the 17 observational. Of the 216 that completed or were terminated, 110 (51%) have results posted.
176 of 398 have an industry lead sponsor. The 10 most frequent:
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
City of Hope Medical Center has 7 studies filed under Lymphoma, B-Cell — fewer than ten, so there is no comparison to draw.
53 of the studies in Lymphoma, B-Cell with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04529772Phase 3Acerta Pharma BVA Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312) | 2027-02-22 |
| NCT04759586Phase 3National Cancer Institute (NCI)Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma | 2027-06-30 |
| NCT05254743Phase 3Loxo Oncology, Inc.A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) | 2027-10 |
| NCT06047080Phase 3Hoffmann-La RocheAn Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma | 2027-10-01 |
| NCT04662255Phase 3Loxo Oncology, Inc.Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | 2027-11 |
Among the 398 studies in Lymphoma, B-Cell with a site in United States, from their registry updates:
This clinical trial compares the effectiveness of geriatric assessment (GA) guided interventions to accelerate functional recovery after chimeric antigen receptor T-cell (CAR-T) therapy compared to standard of care (SOC) in patients 60 years and older with B-cell non-Hodgkin lymphoma (NHL) or multiple myeloma (MM). A large number of patients diagnosed with cancer are over the age of 60, yet most cancer treatments are developed for younger patients. Therefore, older patients may be less likely to be offered stronger treatments, such as CAR-T therapy, due to possible side effects. Geriatric assessment is a multi-dimensional health assessment tool combining patient reported and objective measures covering physical function, mental processes (cognitive), and nutrition. Pre-treatment assessments may identify weaknesses in older adults and may guide interventions for physical therapy, cognitive changes and nutrition to decrease CAR-T therapy side effects and improve care in older adults with NHL or MM.
PRIMARY OBJECTIVE:
I. Evaluate the effects of a GA-informed multi-disciplinary intervention in attenuating physical function decline among older patients receiving CAR-T therapy at day +30 post-CAR-T infusion.
SECONDARY OBJECTIVES:
I. Determine success in coordinating trimodality optimization before lymphodepletion.
II. Compare rates of geriatric syndromes of frailty, cognitive impairment and malnourishment in SOC and GA-intervention cohorts at 30 days post-CAR-T infusion.
III. Evaluate rates and duration of CAR-T related neurotoxicity in SOC and GA-intervention groups.
EXPLORATORY OBJECTIVES:
I. Quantify trimodality optimization intensity throughout treatment course. II. Compare longitudinal trajectory of Short Physical Performance Battery (SPPB), frailty, cognitive impairment and malnourishment between the two arms, at day +100 post-CAR-T infusion.
III. Evaluate quality of life trajectories using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale at baseline and days +30 and +100 in both cohorts.
IV. Incidence of intensive care unit (ICU) admissions by day 100. V. Overall survival, response rate and progression-free survival through one year.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive physical therapy (PT) and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.
ARM II: Patients undergo GA and receive standard of care throughout study.
After completion of study treatment, patients are followed up at day 100 and then up to 1 year.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo GA before lymphodepleting chemotherapy and recommendations based on assessment results communicated to treating physicians. Patients receive PT and delirium prevention education prior to lymphodepletion, at least once before CAR-T therapy, at least 2 times a week while inpatient, and at least once every other week outpatient up to day 30. Additionally, patients receive personalized nutritional guidance from a registered dietician prior to lymphodepletion, prior to CAR-T therapy and at least once a week up to day 30.
Other: Cognitive Intervention · Other: Comprehensive Geriatric Assessment · Other: Nutritional Intervention · Procedure: Physical Therapy · Other: Questionnaire Administration
Patients undergo GA and receive standard of care throughout study.
Other: Best Practice · Other: Questionnaire Administration
Undergo standard of care
Also known as: standard of care, standard therapy
Receive delirium prevention education
Undergo geriatric assessment
Undergo nutritional optimization
Undergo physical function optimization
Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT
Ancillary studies
Changes in Short Physical Performance Battery (SPPB)
T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion.
Time frame: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
Successful in coordinating initial optimization
A physical or virtual visit will be tabulated separately for functional optimization, delirium prevention and nutrition. Adherence will be deemed to have been met if \>=70% or more comlete tri-modality optimization before lymphodepletion in the modified intent to treat population.
Time frame: From enrollment to start of lymphodepletion
Frailty progression
Frailty progression will be defined as a score of 3 or more at T2 if T1 not frail (\<3); if frail at T1 (score 3-5), any worsening of the score; a score of 5 at day 30 if baseline score already at the maximum frailty of 5.
Time frame: At 30 days post CAR-T infusion
Cognitive impairment
Assessed using the Montreal Cognitive Assessment (MoCA). Cognitive impairment defined as MoCA score of \< 23 or unable to complete the MoCA due to cognitive impairment. The proportion of patients with cognitive impairment at day 30, irrespective of baseline cognition, will be compared between the two arms using Chi-square test.
Time frame: At 30 days post CAR-T infusion
Weight loss
Malnourishment will be measured using weight loss and dichotomized as \> 5% weight loss from baseline to day +30. The proportion of patients with over 5% weight loss from T1 to T2 will be compared between the two arms using Chi-square test.
Time frame: Up to 30 days post CAR-T infusion
CAR-T associated neurotoxicity
Assessed using American Society for Transplantation and Cellular Therapy consensus grading for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS). The time to neurotoxicity (days), the maximum grade (1-4) and the duration of neurotoxicity (days) will be recorded. The cumulative incidence of ICANS (percentages) will be compared between arms as well as the maximum grade (1-4), and duration of neurotoxicity (days).
Time frame: Up to day 100
Started Jun 2023 (actual). Primary completion is estimated for Sep 2027, 50 months after the start.
Of 96 non-industry phase 2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 81. This study's planned 50 months is below that.
Counting every sponsor, half of 122 studies reached it within 55 months; a quarter within 34 and three quarters within 77.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Oct 2026 → Sep 2027 and completion Oct 2026 → Sep 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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