A Pilot Trial With Subcutaneous Alemtuzumab and Oral Fludarabinephosphate for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Subcutaneous MabCampath® (Alemtuzumab) and Oral Fludara® (Fludarabinephosphate) for the Treatment of Refractory or Relapsed Chronic Lymphocytic Leukemia in 2nd or 3rd Line of Treatment: A Pilot Trial (FLUSALEM) for the Determination of Safety, Efficacy and Molecular Profiling for the Prediction of Response
Open label multicenter, two-step, non-randomized (pilot) study to analyze the safety of 4 cycles of 3-day 40mg/m2 oral fludarabine with simultaneous thrice weekly application of 30mg alemtuzumab s.c. in patients with B-CLL disease in 1st and 2nd relapse after any primary treatment or with disease refractory to any therapy in 1st or 2nd line (including Fludarabine, ). This regimen is preceded by an escalation phase with 3-10-30 mg of alemtuzumab s.c.
After the first phase (completed treatment of 7 patients) an interim analysis of safety and efficacy will be performed. In case of a sufficient risk benefit assessment followed by the enrollment of further 21 patients. Final analysis of safety and preliminary efficacy will be based on all patients enrolled.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Feldkirch、オーストリア、A-6806
- Landeskrankenhaus Feldkirch
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Fürstenfeld、オーストリア、A-8280
- A.ö. Landeskrankenhaus Fürstenfeld
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Innsbruck、オーストリア、A-6020
- Universitätsklinik Innsbruck/ Klinik für Innere Medizin
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Leoben、オーストリア、A-8700
- A.ö. Landeskrankenhaus Leoben
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Linz、オーストリア、A-4020
- Krankenhaus der Stadt Linz
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Salzburg、オーストリア、A-5020
- St. Johanns LK
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St. Poelten、オーストリア、A-3100
- A.ö. Krankenhaus der Landeshauptstadt St. Pölten
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Wels、オーストリア、A-4600
- Klinikum Kreuzschwestern Wels GmbH
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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
説明
Inclusion Criteria:
- Male or female patients with CD23+, CD5+, CD19+, light chain monoclonal B CLL
- 1st or 2nd relapse after fludarabine or any other primary treatment regimen or refractory to primary or secondary treatment (including fludarabine) and simultaneously indication for treatment according to the NCI Workshop Criteria 1996
- Age 19-75
- WHO performance score 0-2
- Informed consent given by the patient
Exclusion Criteria:
- HIV positive or positive for Hepatitis B or C
- active uncontrolled infection
- child bearing age without adequate control of fertility, pregnant or lactating women
- intolerance towards any ingredient of either oral fludarabine or alemtuzumab
- allergy against foreign proteins
- previous treatment with alemtuzumab
- treatment with an experimental drug within the previous 2 months
- second malignant disease (non CLL)
- CLL in transformation (Richter syndrome)
- decreased kidney-function with creatinine-clearance < 30ml/min
- severe concomitant diseases or major organ dysfunctions
- patients who are unable to comply with the requirements of the protocol
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:なし
- 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:Overall study
The FLUSALEM protocol combines 4 cycles of oral fludarabine phosphate (40mg/m² d1-3; q 29d) and an intensive dose schedule of alemtuzumab (30mg sc.3 times weekly for 16 weeks) in an outpatient setting
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orally, 40 mg/m2 d1-3 q4w, x4 cycles
他の名前:
subcutaneous, starting dose 3 mg and escalation to 10 mg, then 30 mg, followed by 30 mg thrice weekly for 16 weeks in escalated dose
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 |
時間枠 |
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Safety and tolerability
時間枠:within the duration of study
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within the duration of study
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Complete and overall response rate
時間枠:within the duration of study
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within the duration of study
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Infections grade III, IV
時間枠:within the duration of study
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within the duration of study
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Rate of CMV reactivation
時間枠:within the duration of study
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within the duration of study
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二次結果の測定
結果測定 |
時間枠 |
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Time to retreatment
時間枠:within duration of trial
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within duration of trial
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Overall survival
時間枠:within duration of trial
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within duration of trial
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Response in lymphatic compartments
時間枠:within duration of trial
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within duration of trial
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Molecular response/ immunologic MRD response
時間枠:within duration of trial
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within duration of trial
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Quality of Life
時間枠:within duration of trial
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within duration of trial
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協力者と研究者
協力者
捜査官
- 主任研究者:Richard Greil, MD、IIIrd Medical Department for Hematology, Oncology, Rheumatology, Infectiology and Hemostasiology at the Medical University of Salzburg
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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。
Fludarabine phosphateの臨床試験
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University of OxfordMahidol Oxford Tropical Medicine Research Unit; Department of Medical Research, Lower Myanmar引きこもった合併症のない熱帯熱マラリア | アルテミシニン耐性
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Postgraduate Institute of Dental Sciences Rohtakわからない
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Washington University School of Medicine終了しました