Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia. (CLL0911)
2020年10月12日 更新者：Gruppo Italiano Malattie EMatologiche dell'Adulto
Phase 2 Multicenter, Study to Assess the Efficacy and the Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) Chemoimmunotherapy in Young (≤65 Yrs) Patients With Chronic Lymphocytic Leukemia (CLL).
Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia (CLL).
調査の概要
詳細な説明
Given that:
- rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated with a high OR rate, superior PFS and OS as compared to fludarabine and cyclophosphamide regimen;
- a direct relationship between the dose of rituximab and the response rate has been reported;
- ofatumumab, as single agent, proved activity in CLL patients with refractory disease;
- ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been associated with a high complete response (CR) rate;
- the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study drugs (FC) and increase the infection rate; a schedule combining FC with an increased dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be associated with an improvement in the CR rate. The purpose of this study is to determine whether we could improve the CR rate of the golden standard treatment for fit patients with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined with an increased dose of the monoclonal antibody ofatumumab, given every other week (FCO2) associated with a primary prophylaxis of granulocytopenia.
研究の種類
介入
入学 (実際)
80
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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Alessandria、イタリア
- S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
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Ascoli Piceno、イタリア
- Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"
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Asti、イタリア
- S.O.C. di Medicina Interna B - Ospedale - Cardinal Massaia di Asti
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Biella、イタリア
- ASL12 - Biella Ospedale degli Infermi - Dip. di Medicina e Geriatria - Struttura Complessa di Medicina Interna
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Catanzaro、イタリア
- Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
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Ferrara、イタリア
- Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna
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Genova、イタリア
- RCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
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Lecce、イタリア
- ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
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Messina、イタリア
- Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
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Milano、イタリア
- Ospedale Niguarda " Ca Granda"
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Novara、イタリア
- S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
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Palermo、イタリア
- Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
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Parma、イタリア
- Cattedra di Ematologia CTMO Università degli Studi di Parma
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Reggio Calabria、イタリア
- Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
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Reggio Emilia、イタリア
- Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
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Roma、イタリア
- U.O.C. Ematologia - Ospedale S.Eugenio
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Roma、イタリア
- Padiglione Cesalpino - I piano - Divisione di Ematologia - Ospedale S. Camillo
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Roma、イタリア
- Policlinico Umberto I, Hematology Department - Sapienza
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Siena、イタリア
- U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
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Terni、イタリア
- SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni
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Torino、イタリア
- Div. di Ematologia Ospedale "S.Giovanni Battista"
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Udine、イタリア
- Clinica Ematologica - Policlinico Universitario
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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～65年 (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:
- B-cell CLL diagnosis by 2008 revised IWCLL criteria.
- Treatment requirement according to the 2008 revised IWCLL criteria.
- No previous treatment.
- Age > 18 year and . 65 years.
- ECOG performance status of 0-1 at study entry and CIRS score .6.
- Adequate renal function (creatinine clearance.60 ml/min estimated using the Cockcroft-Gaultequation) .
- For male and female subjects of childbearing potential, agreement to use effective contraception.
- Signed written informed const according to ICH/EU/GCP and national local laws.
Exclusion Criteria:
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease and/or laboratory abnormality which in the opinion of the investigator may represent a risk for the patient and/or that would prevent the subject from signing the informed consent form.
- Pregnant or lactating females.
- Known positive serology for HIV.
- Positive serology for Hepatitis B (HBV) defined as a positive test for HBsAg and HBV-DNA.
- HCV-RNA positive.
- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection, tuberculosis and active hepatitis.
- History of tuberculosis within the last five years or recent exposure to tuberculosis equal to or less than 6 months.
- Known presence of alcohol and/or drug abuse.
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to the inclusion in the study, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy.. grade 2 neuropathy; history of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae.
- Uncontrolled autoimmune hemolytic anemia or thrombocytopenia.
One or more laboratory abnormalities:
- Calculated creatinine clearance (Cockroft-Gault)<60mL/min.
- Absolute granulocyte count <1500/ƒÊL not disease related.
- Platelet count < 75000/ƒÊL not disease related.
- GOT, GPT, GT, alkaline phosphatase > 1,5 x upper limit of normal value unless due to disease involvement); serum bilirubin >1.5mg/dL, subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones)
- Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
- Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
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：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：Study therapy
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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 |
|---|---|---|
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Number of complete responses.
時間枠：After 8 months from study entry.
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The complete response (CR) rate after FCO2 front-line treatment.
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After 8 months from study entry.
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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 |
|---|---|---|
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Number of overall responses.
時間枠：After 8 months from study entry.
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Overall Response (OR) rate after FCO2 front-line treatment.
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After 8 months from study entry.
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Number of patients in progression-free survival.
時間枠：After 32 months from study entry.
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Progression-free survival (PFS) calculated from the date of first treatment dose - induction phase - until the date of the first documentation of progressive disease or until death (whatever the cause), whichever occurs first.
Patients still alive and known to be progression free will be censored at the moment of last follow-up.
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After 32 months from study entry.
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Number of patients needing a new CLL Treatment.
時間枠：After 32 months from study entry.
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Time to a new CLL treatment (TTT) will be calculated from the date of last treatment dose until date of a new treatment received for CLL, where death occurred before the new treatment will be considered as competing risk.
Patients still alive without receiving a new treatment will be censored at the time of the last follow-up.
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After 32 months from study entry.
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Number of patients in overall survival
時間枠：After 32 months from study entry.
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Overall survival (OS): defined as the time interval between the date of first treatment dose - induction phase- and the date of death for any cause; patients still alive will be censored at the moment of last follow-up.
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After 32 months from study entry.
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Number of toxic events.
時間枠：After 32 months from study entry.
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Toxicity of treatment according the last NCI criteria.
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After 32 months from study entry.
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Outcome of patients according to clinical and biologica variables.
時間枠：After 32 months from study entry.
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Outcome of patients (response, PFS OS) according to clinical and biologic variables (age; size of nodes, 2-microglobulin, lymphocyte count, stage, IgVH, p53, FISH, ZAP-70, CD38, FLCs).
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After 32 months from study entry.
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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。
捜査官
- スタディチェア：Roberto Foà, Pr.、Policlinico Umberto I, Hematology Department.
- スタディディレクター：Francesca R. Mauro、Policlinico Umberto I, Hematology Department.
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
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 (実際)
2013年11月5日
一次修了 (実際)
2015年11月1日
研究の完了 (実際)
2018年10月1日
試験登録日
最初に提出
2013年1月4日
QC基準を満たした最初の提出物
2013年1月4日
最初の投稿 (見積もり)
2013年1月7日
学習記録の更新
投稿された最後の更新 (実際)
2020年10月14日
QC基準を満たした最後の更新が送信されました
2020年10月12日
最終確認日
2020年10月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CLL0911
- 2011-005329-27 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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。