Anti-PD-1 and Chemotherapy for R/R Hodgkin Lymphoma
Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Pierre-Bénite、フランス
- Centre Hospitalier Lyon Sud
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Initial diagnosis of classical HL
- Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
- Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
- Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
- Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.
Exclusion Criteria:
- radiotherapy in the treatment after anti-PD1
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Group 1 Sequential strategy
Patients for whom anti-PD-1 therapy was stopped with the introduction of a new treatment line (19 patients, 63%).
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Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
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Group 2 Concomitant strategy
Patients for whom a combination of CT with anti-PD-1 therapy was initiated (11 patients, 37 %).
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Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
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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 |
---|---|---|
Overall response rate after re-exposure to chemotherapy
時間枠:10 weeks
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Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria
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10 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Best response obtained (Group 1)
時間枠:10 weeks
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the best response obtained with CT after anti-PD-1
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10 weeks
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Best response obtained (Group 2)
時間枠:10 weeks
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the best response obtained with CT after the combination anti-PD-1 and CT
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10 weeks
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The toxicities experienced during CT or anti-PD-1 plus CT combination
時間枠:10 weeks
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The toxicities were graded retrospectively according to the National Cancer Institute Common Toxicity Criteria for AEs (version 4.0).
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10 weeks
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Outcomes including PFS
時間枠:up to 12 months
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PFS was defined as the time from first relapse, or progression, to the next event (defined as either second relapse/progression, change of therapy, or death from any cause)
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up to 12 months
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Outcomes including overall survival (OS).
時間枠:up to 24 months
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OS was defined as the time from first relapse, or progression, to death from any cause.
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up to 24 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Hervé GHESQUIERES, MD、Hospices Civils de Lyon
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。