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Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma

2010年6月9日 更新者：Case Comprehensive Cancer Center

Randomized Phase II Trial of B-Lymphocyte Purging of Autologous Peripheral Blood Progenitor Cells in Patients With B-Cell Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation.

PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkin's lymphoma.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

OBJECTIVES:

  • Compare the effects of mobilization therapy with or without rituximab on hematopoietic stem cells, B and T lymphocytes, and natural killer cells in patients with advanced or recurrent B-cell non-Hodgkin's lymphoma.
  • Compare the effects of B-lymphocyte purging using concurrent rituximab and mobilization therapy vs a CD34+ cell enrichment device on hematopoietic stem cells, B and T lymphocytes, and natural killer cells in the peripheral blood stem cell (PBSC) infusates.
  • Compare the effect of these purging regimens on tumor cell content of PBSC infusates.
  • Compare the effects of these regimens on myeloid and lymphoid engraftment after high-dose chemotherapy and autologous PBSC infusion in these patients.
  • Compare post-transplantation infection complications in patients treated with these regimens.
  • Compare the response and relapse-free survival of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive mobilization therapy comprising rituximab IV over 2-5 hours on days 1, 8, and 15 and cyclophosphamide IV over 3-6 hours on day 16. Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients then undergo peripheral blood stem cell (PBSC) collection.

After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3 and etoposide IV and cisplatin IV for 3 days during days -7 to -3. Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

Patients receive unmanipulated PBSCs on day 0. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.

  • Arm II: Patients receive mobilization therapy comprising cyclophosphamide and G-CSF and high-dose chemotherapy comprising carmustine, etoposide, and cisplatin as in arm I. Patients may also undergo involved-field radiotherapy as in arm I. Patients receive CD34 cell-enriched PBSC on day 0 followed by G-CSF as in arm I.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 years.

研究の種類

介入

入学 (実際)

37

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

  • アメリカ
    • Ohio
      • Cleveland、Ohio、アメリカ、44106-7284
        • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

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

12年～65年 (子、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

DISEASE CHARACTERISTICS:

  • Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL)

    • Indolent or aggressive histology
    • No small lymphocytic lymphoma, Burkitt's lymphoma, or small lymphocytic non-Burkitt's lymphoma
  • CD20-positive and/or CD19-positive by immunohistochemistry or flow cytometry

  • Second or greater remission allowed

    • Partial remission, relapse, or refractory disease must have measurable tumor
  • Eligible for high-dose therapy followed by autologous peripheral blood stem cell transplantation
  • No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 12 to 65

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,200/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Creatinine clearance at least 60 mL/min
  • No renal dysfunction

Cardiovascular:

  • LVEF at least 40%
  • No cardiac dysfunction
  • No myocardial infarction within the past 3 months

Pulmonary:

  • FEV_1 greater than 60%
  • DLCO at least 60% of predicted
  • No pulmonary dysfunction
  • No asthma

Other:

  • HIV negative
  • No significant organ dysfunction
  • No severe comorbid condition
  • No uncontrolled diabetes
  • No severe or active infection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Chemotherapy
  • No prior immunotherapy

Chemotherapy:

  • No prior high-dose chemotherapy with or without peripheral blood stem cell transplantation
  • No more than 3 prior chemotherapy regimens for NHL
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy allowed

Surgery:

  • Not specified

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：ランダム化
  • 介入モデル：並列代入
  • 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：Arm I: with rituximab IV
生物学的：filgrastim
Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.
生物学的：rituximab
rituximab IV over 2-5 hours on days 1, 8, and 15
薬：carmustine
After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3
薬：cisplatin
After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.
薬：cyclophosphamide
cyclophosphamide IV over 3-6 hours on day 16.
薬：etoposide
After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.
手順：bone marrow ablation with stem cell support
Patients then undergo peripheral blood stem cell (PBSC) collection.
手順：peripheral blood stem cell transplantation
Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.
放射線：radiation therapy
Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.
アクティブコンパレータ：Arm II: without rituximab IV
生物学的：filgrastim
Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.
薬：carmustine
After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3
薬：cisplatin
After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.
薬：cyclophosphamide
cyclophosphamide IV over 3-6 hours on day 16.
薬：etoposide
After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.
手順：bone marrow ablation with stem cell support
Patients then undergo peripheral blood stem cell (PBSC) collection.
手順：peripheral blood stem cell transplantation
Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.
放射線：radiation therapy
Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

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
Total CD34 cells
時間枠：measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
T and B lymphocyte counts
時間枠：measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant
Disease response
時間枠：measured at 4 weeks after the transplant
measured at 4 weeks after the transplant
Engraftment
時間枠：measured at days 42 and 90 after the transplant, and 6 and 12 months after the transplant
measured at days 42 and 90 after the transplant, and 6 and 12 months after the transplant

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

Case Comprehensive Cancer Center

協力者

National Cancer Institute (NCI)

捜査官

  • スタディチェア：Omer N. Koc, MD、Case Comprehensive Cancer Center

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

2000年6月1日

一次修了 (実際)

2005年3月1日

試験登録日

最初に提出

2002年1月4日

QC基準を満たした最初の提出物

2003年1月26日

最初の投稿 (見積もり)

2003年1月27日

学習記録の更新

投稿された最後の更新 (見積もり)

2010年6月10日

QC基準を満たした最後の更新が送信されました

2010年6月9日

最終確認日

2010年6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

  • CWRU1499 (その他の識別子：Case Comprehensive Cancer Center)
  • P30CA043703 (米国 NIH グラント/契約)
  • CWRU-030040
  • NCI-G01-2040

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。

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