B세포 비호지킨 림프종 또는 다발성 골수종을 앓고 있는 60세 이상 환자의 CAR-T 치료 후 기능 회복을 가속화하기 위한 노인 평가 유도 중재, GOCART 연구
B세포 비호지킨 림프종 또는 다발성 골수종(GOCART)을 앓고 있는 60세 이상 환자의 키메라 항원 수용체 T세포(CAR-T) 치료 후 기능 회복을 가속화하기 위한 노인성(G) 평가 유도 최적화(O)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- 모병
- City of Hope Medical Center
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연락하다:
- Andrew S. Artz
- 전화번호: 626-218-2405
- 이메일: aartz@coh.org
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수석 연구원:
- Andrew S. Artz
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Irvine, California, 미국, 92618
- 모병
- City of Hope at Irvine Lennar
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연락하다:
- Andrew Artz, MD
- 전화번호: 626-218-2405
- 이메일: aartz@coh.org
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- 모병
- Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
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연락하다:
- Heidi Klepin, MD
- 전화번호: 336-716-2255
- 이메일: hklepin@wakehealth.edu
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Ohio
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Columbus, Ohio, 미국, 43210
- 모병
- Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
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연락하다:
- Ashley Rosko, MD
- 전화번호: 614-293-7807
- 이메일: ashley.rosko@osumc.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Ability to provide informed consent
- Patient's physician must agree for patient participation. A physician may elect to provide blanket agreement for participation of any eligible CAR-T patient under their care
- Ability to read English, or Spanish. Other languages will be acceptable with site principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
- Age: >= 60 years at the time of enrollment
- Scheduled to receive an Food and Drug Administration (FDA)-approved CAR-T for treatment of multiple myeloma or B-cell non- Hodgkin lymphoma
- Willing and able to complete study requirements
- Patients expect to be able to participate at least once before lymphodepletion with trimodality optimization visits
Exclusion Criteria:
- Prior CAR-T therapy
- Any condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I (PT, cognitive education, nutrition education)
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. |
Ancillary studies Receive delirium prevention education Undergo geriatric assessment Undergo nutritional optimization Undergo physical function optimization
다른 이름들:
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활성 비교기: Arm II (standard of care)
Patients undergo GA and receive standard of care throughout study. |
Ancillary studies Undergo standard of care
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Short Physical Performance Battery (SPPB)
기간: From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
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T-test will be used to compare SPPB changes score between two arms at 30 days after CAR-T infusion. |
From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Successful in coordinating initial optimization
기간: From enrollment to start of lymphodepletion
|
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. |
From enrollment to start of lymphodepletion
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Frailty progression
기간: At 30 days post CAR-T infusion
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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. |
At 30 days post CAR-T infusion
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Cognitive impairment
기간: At 30 days post CAR-T infusion
|
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. |
At 30 days post CAR-T infusion
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Weight loss
기간: Up to 30 days post CAR-T infusion
|
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. |
Up to 30 days post CAR-T infusion
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CAR-T associated neurotoxicity
기간: Up to day 100
|
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). |
Up to day 100
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew S Artz, City of Hope Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 혈관 질환
- 심혈관 질환
- 신생물
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 혈액 질환
- 림프계 질환
- 림프 증식 장애
- 면역증식성 장애
- 림프종, 비호지킨
- 림프종
- 신생물, 형질세포
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 출혈성 장애
- 헴 및 림프병
- 림프종, B세포
- 다발성 골수종
- 보건 서비스 관리
- 건강 관리 품질, 접근 및 평가
- 조사 기술
- 역학적 방법
- 치료학
- 데이터 수집
- 건강 관리 평가 메커니즘
- 건강 관리의 질
- 공중 위생
- 환경 및 공중 보건
- 품질 지표, 건강 관리
- 인구 특성
- 복권
- 건강 상태
- 인구 통계학
- 역학 측정
- 주제로 지침
- 품질 보증, 건강 관리
- 치료의 표준
- 주제로 지침을 연습하십시오
- 노인 평가
- 물리 치료 양식
기타 연구 ID 번호
- 22422
- P30CA033572 (미국 NIH 보조금/계약)
- 22422 (기타 식별자: City of Hope Medical Center)
- NCI-2023-04359 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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