A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
2014年11月17日 更新者：Hoffmann-La Roche
Clinical Response in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma After Treatment With Anti-CD20 Antibody IDEC C2B8 (MabThera)
This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma.
Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response).
The anticipated time on study treatment is <3 months.
調査の概要
研究の種類
介入
入学 (実際)
38
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Erlangen、ドイツ、91054
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Grenzach-wyhlen、ドイツ、79639
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Göttingen、ドイツ、37075
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Hannover、ドイツ、30625
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Homburg/saar、ドイツ、66424
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Köln、ドイツ、50924
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Muenchen、ドイツ、80336
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Muenchen、ドイツ、81377
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Muenster、ドイツ、48129
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Stuttgart、ドイツ、70376
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Tübingen、ドイツ、72076
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- adult patients >= 18 years of age;
- centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
- relapse after chemotherapy (with or without interferon maintenance therapy).
Exclusion Criteria:
- primary refractory lymphomas;
- more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
- clinically significant cardiac disease.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：単一グループの割り当て
- 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：マブセラ/リツキサン
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375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
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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 |
|---|---|---|
|
Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)
時間枠：Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Percentage of participants with a CR, PR at the end of the first cycle of treatment (Week 4).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1.500/ microliter (µL), hemoglobin (Hb) >12 grams per deciliter (g/dL), and platelets >100,000/µL.
PR was defined as a less than (<) 50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
|
Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With a Clinical Response
時間枠：Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Clinical response was defined as the best response after the first 4 weeks of treatment cycle by the following categories: CR, PR, minor response (MR), stable disease (SD), and progressive disease (PD).
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Best Response
時間枠：Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from start of the treatment (first application) until best response (PR or CR).
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Duration of Remission
時間枠：Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Median time, in months, between the documentation of CR or PR and PD in clinical responders.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Time to Progression
時間枠：Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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The median time, in months, from the start of treatment (first application) until detection of PD.
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Treatment start until progression of disease or last available follow-up. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Overall Survival (OS)
時間枠：Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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OS was defined as the time, in months, between enrollment into the study and death, due to any cause.
Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
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Enrollment into study until end of follow-up or death. The median length of follow-up was 6.6 months (range: 0-97.8 months)
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Number of Participants With a Clinical Response to Re-Treatment
時間枠：First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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Clinical response was defined as the best response after the second 4 weeks of treatment cycle by the following categories: CR, PR, MR, SD, and PD.
CR was defined as the complete disappearance of all objective disease findings, including enlarged lymph nodes, hepatomegaly, and splenomegaly for at least 4 weeks, and a normalization of blood counts with granulocytes >1,500/μL, Hb >12 g/dL, and platelets >100,000/μL.
PR was defined as <50% regression of all measurable and evaluable lymphoma manifestations (sum of the products of the 2 largest diameters vertical to each other) for at least 4 weeks without the appearance of new manifestations, and normalization of blood counts.
MR was defined as tumor regression ≥25% and <50%.
SD was defined as tumor regression <25%, no new manifestations, and progression ≤25%.
PD was defined as no new lymphoma associated symptoms or an increase in the size of manifestations by more than 25%.
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First application in the second treatment cycle until progression of disease. The median length of follow-up was 4.6 months (range: 0.5-20.6 months).
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
1997年1月1日
一次修了 (実際)
2008年2月1日
研究の完了 (実際)
2008年2月1日
試験登録日
最初に提出
2013年11月25日
QC基準を満たした最初の提出物
2013年11月25日
最初の投稿 (見積もり)
2013年12月2日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年12月3日
QC基準を満たした最後の更新が送信されました
2014年11月17日
最終確認日
2014年10月1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。