このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia (AML1310)

2018年8月3日 更新者：Gruppo Italiano Malattie EMatologiche dell'Adulto

Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia. GIMEMA Protocol AML1310. EudraCT Number 2010-023809-36

The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive results in terms of overall survival at 24 months.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of Minimal Residual Disease (MRD) to establish the final risk assignment and treatment of younger (≤ 60 years) patients with Acute Myeloid Leukemia (AML). Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity.

All patients will receive induction and consolidation chemotherapy according to the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) LAM99P protocol. After the first consolidation, patients belonging to the low-risk category (core binding factor positive AML without c-Kit mutations, NPM1 positive FLT3 negative AML) will receive autologous stem cell transplantation, patients with high-risk features (adverse-risk karyotype, FLT3-ITD mutations), will be assigned to allogeneic stem cell transplantation. Patients with FLT3-TKD mutations or c-Kit mutated core binding factor positive AML and those belonging to the intermediate-risk karyotype category will be stratified according to MRD by flow cytometry and will receive risk-adapted treatment (autologous vs. allogeneic stem cell transplantation). All patients who meet the criteria for high-risk definition will be offered the allogeneic transplantation option regardless of the availability of a Human Leukocyte Antigen (HLA) identical sibling. In fact, for those lacking a HLA identical sibling all the other sources of hematopoietic stem cells (matched unrelated donor from international registry, unrelated cord blood, family haploidentical donor) will be considered. Autologous or allogeneic stem cell transplantation will be performed within 3 months from the end of consolidation therapy.

研究の種類

介入

入学 (予想される)

515

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

  • イタリア
      • Alessandria、イタリア
        • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
      • Ancona、イタリア
        • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
      • Avellino、イタリア
        • Az. Ospedaliera S. G. Moscati
      • Bari、イタリア、70010
        • Unità Operativa Ematologia 1 - Università degli Studi di Bari
      • Barletta、イタリア
        • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
      • Bologna、イタリア
        • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
      • Brindisi、イタリア
        • Divisione di Ematologia Ospedale A. Perrino
      • Cagliari、イタリア
        • Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
      • Caserta、イタリア
        • Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
      • Catania、イタリア
        • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
      • Catanzaro、イタリア、88100
        • Azienda Ospedaliera Pugliese Ciaccio
      • Civitanova、イタリア
        • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
      • Cona、イタリア
        • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
      • Cremona、イタリア
        • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
      • Ferrara、イタリア、44100
        • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
      • Foggia、イタリア
        • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
      • Genova、イタリア
        • Clinica Ematologica - Università degli Studi
      • Latina、イタリア
        • Divisione di Ematologia Ospedale "Santa Maria Goretti"
      • Lecce、イタリア
        • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematol
      • Meldola、イタリア
        • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
      • Messina、イタリア
        • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
      • Messina、イタリア
        • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
      • Milano、イタリア
        • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
      • Milano、イタリア
        • Ospedale Niguarda " Ca Granda"
      • Modena、イタリア
        • Centro Oncologico Modenese - Dipartimento di Oncoematologia
      • Napoli、イタリア
        • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
      • Nocera Inferiore、イタリア
        • Pr. Alfonso Maria D'Arco
      • Novara、イタリア
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
      • Orbassano、イタリア、10043
        • Ospedale S. Luigi Gonzaga
      • Padova、イタリア
        • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
      • Palermo、イタリア
        • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
      • Palermo、イタリア、90146
        • Ospedale Riuniti "Villa-Sofia-Cervello"
      • Parma、イタリア
        • Cattedra di Ematologia CTMO Università degli Studi di Parma
      • Perugia、イタリア
        • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
      • Pesaro、イタリア
        • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
      • Pescara、イタリア、61100
        • Azienda ASL di Pescara
      • Piacenza、イタリア
        • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
      • Pisa、イタリア
        • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
      • Potenza、イタリア
        • Ematologia - Ospedale San Carlo
      • Ravenna、イタリア、48100
        • Ospedale S.Maria delle Croci
      • Reggio Calabria、イタリア
        • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
      • Reggio Emilia、イタリア
        • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
      • Rimini、イタリア
        • Ospedale "Infermi"
      • Roma、イタリア
        • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
      • Roma、イタリア
        • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
      • Roma、イタリア
        • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
      • Roma、イタリア、00168
        • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
      • Roma、イタリア、00128
        • Divisione Ematologia - Università Campus Bio-Medico
      • Rome、イタリア
        • U.O.C. Ematologia - Ospedale S.Eugenio
      • Rome、イタリア
        • Ospedale S. Camillo
      • Rozzano、イタリア
        • Sezione di Ematologia Cancer Center Humanitas
      • San Giovanni Rotondo、イタリア
        • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
      • Sassari、イタリア
        • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
      • Siena、イタリア
        • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
      • Taormina、イタリア
        • UOC di Ematologia Generale P.O. S.Vincenzo
      • Taranto、イタリア
        • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
      • Treviso、イタリア
        • Azienda U.L.S.S.9 - U.O. di Ematologia
      • Udine、イタリア、33100
        • Policlinico Universitario - Clinica Ematologia
    • (le)
      • Tricase、(le)、イタリア
        • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
    • (rm)
      • Roma、(rm)、イタリア、00184
        • Complesso Ospedaliero S. Giovanni Addolorata
      • Rome、(rm)、イタリア、00133
        • Policlinico di Tor Vergata

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～60年 (大人)

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:

  • Signed written informed consent according to ICH/EU/GCP and national/local laws
  • Patients aged between 18 and 60 years
  • Patients previously untreated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days hydroxyurea (HU)), radiotherapy or more than 7 days corticosteroids
  • Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of more than 6 months duration)
  • WHO performance status 0-3
  • Adequate renal (serum creatinine < 2 x the institutional Upper Limit of Normal (ULN)) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST ≤ 3 x ULN) function, unless considered due to organ leukemic involvement
  • Left Ventricular Ejection Fraction (LVEF) >50%, as determined by echocardiogram
  • Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection
  • Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.

Exclusion Criteria:

  • Patients aged less than 18 or more than 60 years
  • Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids
  • Acute promyelocytic leukaemia
  • Blast crisis of chronic myeloid leukaemia
  • AML supervening after other myeloproliferative disease
  • AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration
  • Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason
  • Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit)
  • Severe heart failure requiring diuretics
  • Ejection fraction < 50%
  • Uncontrolled infections
  • WHO performance status = 4
  • Severe concomitant neurological or psychiatric diseases
  • Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.

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
実験的：MRD-directed therapy
他の：Risk-adapted, MRD-directed therapy
The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of MRD to establish the final risk assignment and treatment of younger (≤ 60 years) patients with AML. Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity.

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
Treatment strategy in terms of Overall Survival (OS) at 24 months.
時間枠：24 months from study entry.
OS is defined as the time interval between the date of study entry and death for any cause; patients still alive will be censored at the time of the last follow-up.
24 months from study entry.

二次結果の測定

結果測定
メジャーの説明
時間枠
Estimation of Disease Free Survival (DFS) from Complete Response (CR) evaluation.
時間枠：At 24 months from study entry
DFS is defined as the time interval between the evaluation of CR -after induction phase- and relapse or death in CR; patients still alive, in first CR, will be censored at the time of the last follow-up.
At 24 months from study entry
Estimation of Event Free Survival (EFS) from study entry.
時間枠：at 24 months from study entry
EFS is defined as the time interval between the date of study entry dose and failure during induction phase, relapse or death whichever comes first; patients still alive, in first CR, will be censored at the time of the last follow-up.
at 24 months from study entry
Rate of patients in CR after induction therapy
時間枠：At 31 days from study entry if pts are in CR or at 69 days from study entry if pts are in PR after 1 induction cycle
At 31 days from study entry if pts are in CR or at 69 days from study entry if pts are in PR after 1 induction cycle
Toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
時間枠：From study entry to study completion (6 months therapy + 18 months follow-up)
From study entry to study completion (6 months therapy + 18 months follow-up)
Estimation of OS, EFS, DFS and Cumulative Incidence of Relapse (CIR) according to risk groups (Low, Intermediate, High)
時間枠：At 24 months from study entry
CIR is calculated from the date of achievement of the CR -after induction phase-, using the cumulative incidence method, considering death in CR as a competing risk. Patients still alive, without relapse, will be censored at the time of the last follow-up.
At 24 months from study entry
Estimation of OS, EFS, DFS and CIR according to the Minimal Residual Disease (MRD) level at each evaluation step
時間枠：At 24 months from study entry
At 24 months from study entry
Rate of CR patients and estimation OS, EFS, DFS and CIR according to baseline characteristics such as age, performance status, white blood cell (WBC), morphology, cytogenetic and molecular features.
時間枠：At 24 months from study entry
At 24 months from study entry
Quality of Life evaluation
時間枠：Before treatment starts, after induction, at one year after baseline evaluation.

QoL should be measured at three different time points:

  1. At Baseline (before treatment starts).
  2. At the end of Induction phase (after evaluation of response and before start of consolidation therapy for patients in CR or salvage therapy for patients not achieving a CR).
  3. At one year after baseline evaluation.
Before treatment starts, after induction, at one year after baseline evaluation.

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

Gruppo Italiano Malattie EMatologiche dell'Adulto

捜査官

  • 主任研究者：Adriano VENDITTI, Pr.、Policlinico Tor Vergata di Roma

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。

一般刊行物

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)

2012年1月1日

一次修了 (実際)

2017年7月1日

研究の完了 (実際)

2018年7月10日

試験登録日

最初に提出

2011年10月12日

QC基準を満たした最初の提出物

2011年10月14日

最初の投稿 (見積もり)

2011年10月17日

学習記録の更新

投稿された最後の更新 (実際)

2018年8月6日

QC基準を満たした最後の更新が送信されました

2018年8月3日

最終確認日

2018年8月1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

  • AML1310

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。

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Sweden

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

3
購読する