HDM2005 Combination Therapy in Relapsed/Refractory Mantle Cell Lymphoma
A Phase Ib/III Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed/Refractory Mantle Cell Lymphoma
This is a Phase Ib/III, multicenter, open-label clinical study of HDM2005 in combination with rituximab and lenalidomide in adult patients with relapsed or refractory mantle cell lymphoma.
Mantle cell lymphoma is a type of non-Hodgkin lymphoma. Some patients have disease that comes back after treatment or does not respond well to available treatments. This study is designed to evaluate whether adding HDM2005 to rituximab and lenalidomide may provide clinical benefit for patients with relapsed or refractory mantle cell lymphoma who have previously received an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor.
The study includes two parts. In the Phase Ib part, participants will receive HDM2005 in combination with rituximab and lenalidomide. The main goals of this part are to evaluate the safety and tolerability of the combination, assess preliminary anti-tumor activity, and determine the recommended dose of HDM2005 for the Phase III part.
In the Phase III part, eligible participants will be randomly assigned to receive either HDM2005 at the recommended Phase III dose in combination with rituximab and lenalidomide, or the investigator's choice of comparator treatment with rituximab plus lenalidomide or bendamustine plus rituximab. The main goals of the Phase III part are to compare the anti-tumor activity and clinical benefit of the HDM2005 combination with the comparator treatments. The main measures of efficacy include objective response rate and progression-free survival, assessed according to the 2014 Lugano response criteria. The study will also evaluate safety, pharmacokinetics, immunogenicity, overall survival, duration of response, and other measures of anti-tumor activity.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Ruichao Zeng, PhD
- 電話番号：+86-571-899033 +86-571-89903388
- メール：zengruichao@eastchinapharm.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adult participants aged 18 years or older.
- Histologically confirmed mantle cell lymphoma with cyclin D1 overexpression or documented t(11;14).
- Relapsed or refractory mantle cell lymphoma after prior treatment with an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor, unless a BTK inhibitor was not suitable or was not tolerated.
- At least one measurable lesion according to the 2014 Lugano response criteria.
- Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part.
- Adequate organ and bone marrow function as defined in the protocol.
- Estimated life expectancy of more than 3 months.
- Willingness to provide archived or fresh tumor tissue for central pathology review, if available.
- Willingness to follow the study treatment plan, visit schedule, and contraceptive requirements.
- Written informed consent provided before any study-specific procedures.
Exclusion Criteria:
- Leukemic non-nodal mantle cell lymphoma.
- Known central nervous system involvement by lymphoma.
- Prior treatment with a ROR1-targeted therapy.
- Active or uncontrolled infection requiring systemic treatment.
- Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol.
- History or current evidence of interstitial lung disease, active interstitial lung disease, or radiation pneumonitis requiring steroid treatment.
- Clinically significant cardiovascular or cerebrovascular disease that may increase study risk.
- Prior allogeneic hematopoietic stem cell transplantation with active or clinically significant graft-versus-host disease, or need for systemic immunosuppressive treatment for graft-versus-host disease.
- Prior solid organ transplantation.
- Other active malignancy or malignancy with a clinically significant risk of recurrence, except for certain adequately treated cancers as defined in the protocol.
- Unresolved clinically significant toxicity from prior anti-cancer therapy.
- Recent anti-cancer therapy, investigational treatment, major surgery, or radiotherapy within the protocol-defined washout period.
- Known allergy or contraindication to any study treatment or its components.
- Active autoimmune disease or immunodeficiency requiring systemic treatment, except for protocol-defined stable conditions.
- Pregnancy, breastfeeding, or planned pregnancy during the study.
- Any medical, psychiatric, laboratory, or social condition that, in the investigator's judgment, may interfere with study participation, study assessments, or participant safety.
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：処理
- 割り当て：非ランダム化
- 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 |
|---|---|
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実験的：Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len
Participants in this Phase Ib cohort will receive HDM2005 1.2 mg/kg in combination with rituximab and lenalidomide during induction treatment.
|
HDM2005 will be administered in combination with rituximab and lenalidomide.
他の名前：
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実験的：Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len
Participants in this Phase Ib cohort will receive HDM2005 1.4 mg/kg in combination with rituximab and lenalidomide during induction treatment.
|
HDM2005 will be administered in combination with rituximab and lenalidomide.
他の名前：
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実験的：Phase III Active Arm: HDM2005 plus rituximab and lenalidomide
HDM2005 will be administered in combination with rituximab and lenalidomide.
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HDM2005 will be administered in combination with rituximab and lenalidomide.
他の名前：
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アクティブコンパレータ：Phase III Control Arm: Rituximab plus lenalidomide
Rituximab plus lenalidomide is used as part of the HDM2005 combination regimen as control arm.
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Rituximab plus lenalidomide is used as part of the HDM2005 combination regimen and may also be selected as comparator treatment in the Phase III part.
他の名前：
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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 |
|---|---|---|
|
Phase Ib: Incidence and severity of adverse events
時間枠：From the date of first dose until end of treatment, assessed up to 12 months.
|
Incidence and severity of adverse events, serious adverse events, and adverse events of special interest will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Dose interruptions, dose modifications, laboratory test results, vital signs, and other safety assessments will also be evaluated.
|
From the date of first dose until end of treatment, assessed up to 12 months.
|
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Phase Ib: Objective response rate assessed by investigator
時間枠：From the first dose of study treatment until disease progression, or other protocol re-specified reasesons, whichever occurs first, assessed up to 11 months.
|
Objective response rate is defined as the proportion of participants who achieve complete response or partial response as assessed by the investigator according to the 2014 Lugano response criteria.
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From the first dose of study treatment until disease progression, or other protocol re-specified reasesons, whichever occurs first, assessed up to 11 months.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- HDM2005-301
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
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。
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