GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving GM-CSF together with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
調査の概要
状態
条件
詳細な説明
OBJECTIVES:
Primary
- Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma.
Secondary
- Evaluate the time to progression in patients treated with this regimen.
- Evaluate the overall survival of patients treated with this regimen.
- Evaluate the duration of response in patients treated with this regimen.
- Evaluate the safety profile of this regimen in these patients.
- Evaluate the influence of FcγR polymorphisms on clinical response.
- Monitor FcγR-expressing cells in peripheral blood during treatment.
- Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
- Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1. Treatment repeats every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Blood and bone marrow samples are collected at baseline and periodically during study for analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR polymorphisms.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.
研究の種類
入学 (予想される)
段階
- フェーズ2
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
DISEASE CHARACTERISTICS:
Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
- Grade 1-3a disease
- Stage II-IV disease
- Non-bulky disease
- Must have undergone initial nodal biopsy within the past 4 months
- At least 1 measurable lesion
Low tumor-burden, as defined by the following GELF criteria:
- Nodal or extranodal tumor mass (diameter < 7 cm)
- No systemic B symptoms
- No increased LDH and β2 microglobulinemia
- No substantial splenic enlargement
- No serous effusion
- No compression syndrome
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active hepatitis
PRIOR CONCURRENT THERAPY:
- No prior treatment, including steroids and radiotherapy
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
- マスキング：なし（オープンラベル）
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 |
|---|
|
Overall objective tumor response rate at the end of induction therapy
|
二次結果の測定
結果測定 |
|---|
|
進行までの時間
|
|
全生存
|
|
応答時間
|
|
安全性プロファイル
|
|
次の治療までの時間
|
|
Influence of FcγR polymorphisms on clinical response and survival
|
|
FcγR expression during study treatment
|
|
Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay
|
協力者と研究者
捜査官
- 主任研究者：Jean-Francois Rossi, MD, PhD、Hopital Lapeyronie-CHU Montpellier
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
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
- GOELAMS-FL2008-RGM
- CDR0000637112 (レジストリ識別子：PDQ (Physician Data Query))
- EUDRACT-2007-005580-95
- RECF0906
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。
遺伝子発現解析の臨床試験
-
Foundation for Innovative New Diagnostics, SwitzerlandUniversity of Witwatersrand, South Africa; PD Hinduja Hospital and Medical Research Centre,... と他の協力者完了
-
The Center for the Biology of Chronic Disease完了エプスタイン-バーウイルス感染症 | サイトメガロウイルス感染症 | ヒトパピローマウイルス | 単純ヘルペス感染症 | 水痘帯状疱疹ウイルス感染症アメリカ
-
University of BaselNational Cancer Center, Korea; University Hospital, Geneva; Swiss National Science Foundation; University... と他の協力者募集
-
Shire完了
-
University of North Carolina, Chapel HillCenters for Disease Control and Prevention完了
-
National Institute for Medical Research, TanzaniaUniversity of Kinshasa (UNIKIN), Congo, The Democratic Republic of the ( Prof Vivi Maketa); Research... と他の協力者まだ募集していませんCOVID-19（新型コロナウイルス感染症）
-
Michigan State University募集敗血症 | 全身性炎症反応症候群 | 感染症、細菌 | 感染症、コロナウイルス | 感染症、真菌 | 混合感染アメリカ
-
Hvidovre University HospitalElsassFonden終了しました