60歳以上のB細胞非ホジキンリンパ腫または多発性骨髄腫患者に対するCAR-T療法後の機能回復を促進するための高齢者評価に基づく介入、GOCART研究
60歳以上のB細胞非ホジキンリンパ腫または多発性骨髄腫（GOCART）患者に対するキメラ抗原受容体T細胞（CAR-T）療法後の機能回復を促進するための老年病（G）評価に基づく最適化（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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- 募集
- City of Hope Medical Center
-
コンタクト：
- Andrew S. Artz
- 電話番号：626-218-2405
- メール：aartz@coh.org
-
主任研究者：
- Andrew S. Artz
-
Irvine、California、アメリカ、92618
- 募集
- City of Hope at Irvine Lennar
-
コンタクト：
- Andrew Artz, MD
- 電話番号：626-218-2405
- メール：aartz@coh.org
-
-
North Carolina
-
Winston-Salem、North Carolina、アメリカ、27157
- 募集
- Wake Forest University, School of Medicine Dept. of Internal Medicine, Division of Hematology Oncology
-
コンタクト：
- Heidi Klepin, MD
- 電話番号：336-716-2255
- メール：hklepin@wakehealth.edu
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- 募集
- Ohio State University Medical Center Dept. of Internal Medicine, Division of Hematology
-
コンタクト：
- Ashley Rosko, MD
- 電話番号：614-293-7807
- メール：ashley.rosko@osumc.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
|
|
アクティブコンパレータ：Arm II (standard of care)
Patients undergo GA and receive standard of care throughout study. |
Ancillary studies Undergo standard of care
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Short Physical Performance Battery (SPPB)
時間枠：From baseline to day 30 after chimeric antigen receptor T-cell (CAR-T) infusion
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Successful in coordinating initial optimization
時間枠：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
|
|
Frailty progression
時間枠：At 30 days post CAR-T infusion
|
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
|
|
Cognitive impairment
時間枠：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
|
|
Weight loss
時間枠：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
|
|
CAR-T associated neurotoxicity
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Andrew S Artz、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
- 血管疾患
- 心血管疾患
- 新生物
- 免疫系疾患
- 組織型別の新生物
- 血液疾患
- リンパ疾患
- リンパ増殖性疾患
- 免疫増殖性疾患
- リンパ腫、非ホジキン
- リンパ腫
- 新生物、形質細胞
- 止血障害
- パラタンパク血症
- 血液タンパク質障害
- 出血性疾患
- ヘミックおよびリンパ疾患
- リンパ腫、B細胞
- 多発性骨髄腫
- 保健サービス管理
- ヘルスケアの質、アクセス、評価
- 調査手法
- 疫学的方法
- 治療
- データ収集
- ヘルスケア評価メカニズム
- ヘルスケアの質
- 公衆衛生
- 環境と公衆衛生
- 品質指標、ヘルスケア
- 人口特性
- リハビリテーション
- 健康状態
- 人口統計
- 疫学的測定
- トピックとしてのガイドライン
- 品質保証、ヘルスケア
- ケアの標準
- トピックとしてガイドラインを練習します
- 老人評価
- 理学療法のモダリティ
その他の研究ID番号
- 22422
- P30CA033572 (米国 NIH グラント/契約)
- 22422 (その他の識別子：City of Hope Medical Center)
- NCI-2023-04359 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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