Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
A Long-Term Follow-Up Study Evaluating the Efficacy and Delayed Toxicities of Radioiodinated Tositumomab (Anti-CD20 Antibody) Followed by Autologous Transplantation for Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.
PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I^131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296, 521, 792, or 915.
- Determine the long-term toxic effects of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a long-term, follow-up study.
Patients undergo testing for human anti-mouse antibody at 1, 3 and 12 months. Patients undergo physical examinations, blood tests, and immune system assessments every 3 months for 1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at 1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if clinically indicated) annually for up to 10 years.
Quality of life is assessed annually.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98109-1024
- Fred Hutchinson Cancer Research Center
-
-
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
サンプリング方法
調査対象母集団
Patients previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:
- FHCRC-296
- FHCRC-521
- FHCRC-792
- FHCRC-915
説明
DISEASE CHARACTERISTICS:
Diagnosis of B-cell non-Hodgkin's lymphoma
- Relapsed or refractory disease
Previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols:
- FHCRC-296
- FHCRC-521
- FHCRC-792
- FHCRC-915
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
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
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 |
|---|---|
|
Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually
時間枠：Annual throughout survival
|
Annual throughout survival
|
|
Toxicity of patients on phase I and II trials by NCI CTC scale annually
時間枠：Annual throughout survival
|
Annual throughout survival
|
協力者と研究者
捜査官
- 主任研究者：Oliver W. Press, MD, PhD、Fred Hutchinson Cancer Center
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 (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
その他の研究ID番号
- 1734.00
- FHCRC-1734.00
- CDR0000398806 (レジストリ識別子：PDQ)
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。