Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
2017年3月17日 更新者：Dr. Neil Berinstein、Sunnybrook Health Sciences Centre
Phase II Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012.
The primary objectives of this previous trial was to assess progression free survival and overall survival.
Of the 36 patients in this trial, approximately 18 remain in remission.
In this new follow up trial, follow up data will prospectively be collected on patients who provide informed consent to do so.
調査の概要
研究の種類
観察的
入学 (実際)
12
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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Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences Centre, Odette Cancer Centre
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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
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Twelve patients with low grade follicular lymphoma who consented to long term follow-up and were previously treated with high dose therapy and autologous stem cell transplant with rituximab and alpha interferon as part of the phase II trial Treatment of Follicular Non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
説明
Inclusion Criteria:
- Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
- Central pathology review before registration
- Ann Arbor stage III or IV
- Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
- ECOG performance status of <2.
- Patients may have received not more than 1 prior course (4 infusions) of rituximab. Timing from last dose of rituximab must exceed 6 months prior to registration. Patients must have demonstrated at least a PR to rituximab if previously administered.
- Patient consent according to institutional and university human experimentation committee requirements
Adequate Renal, hepatic and hematopoietic function test unless the abnormal values are thought to be due to involvement with lymphoma as defined by:
- Hb> 85
- ANC >1000/mm3
- Platelets >100,000/mm3
- Serum/Total Bilirubin >=2 SI units
- AST/ALT <2x Upper Limit of Normal
Exclusion Criteria:
- Positive serology for HIV
- Uncontrolled Infection
- Pregnancy
- CNS Metastases
- History of Psychiatric Disorder
- Other Malignancy (except nonmelanoma skin cancer)
- Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
- Major surgery, other than diagnostic surgery, within four weeks.
- Presence of anti-murine antibody (HAMA) reactivity. These laboratory results must be available prior to receiving treatment for those patients
- who have received prior murine proteins or patients who have allergies to murine proteins.
- New York Heart Association Class III or IV heart disease (see Appendix H, Clinical Evaluation of Functional Capacity of Patients with Heart Disease in Relation to Ordinary Physical Activity) or myocardial infarction within the past six months.
- Treatment with an investigational drug within 30 days or five half-lives (of the study drug with the longest half-life) prior to entry into the study, which ever is longer.
- Previous chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the last 5 years.
- History of allergic reactions to compounds chemically related to Rituximab.
- Refusal to practice contraception if of reproductive potential.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Treatment Arm
Patients who had previously undergone high dose therapy with stem cell support followed by consolidation with Rituximab and alpha-interferon as part of the trial Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon.
The patients in this arm have consented to long-term follow up.
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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 |
|---|---|---|
|
Overall survival
時間枠：through study completion, up to 15 years
|
Number of months from date of enrollment to date of death or last follow-up, whichever comes first.
|
through study completion, up to 15 years
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Progression-free survival
時間枠：through study completion, up to 15 years
|
Number of months from date of enrollment to date of progression.
Progression is defined as a greater than or equal to 50% increase in the sum of the product of measurable lesions.
Appearance of new lesions will also constitute progressive disease.
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through study completion, up to 15 years
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Event-free survival
時間枠：through study completion, up to 15 years
|
Number of months from date of enrollment to date of an event.
An event is defined as death, disease progression, transformation, or development of secondary malignancy.
|
through study completion, up to 15 years
|
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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Adverse events possibly or probably related to transplant
時間枠：through study completion, up to 15 years
|
Adverse events include second malignancies, myelodysplastic syndrome (MDS), hypogammaglobulinemia, and pulmonary fibrosis.
This outcome measurement is descriptive.
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through study completion, up to 15 years
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Minimal Residual Disease
時間枠：through study completion, up to 15 years
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This exploratory endpoint is used to evaluate the detection of recurrent lymphoma in peripheral blood DNA.
It is measured as real-time quantitative polymerase chain reaction (RQ-PCR) and is expressed as a percent of detection per 100,000 cells at each follow-up time point.
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through study completion, up to 15 years
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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
- 主任研究者：Neil Berinstein, MD、Sunnybrook Health Sciences Centre
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9月20日
一次修了 (実際)
2017年3月15日
研究の完了 (実際)
2017年3月15日
試験登録日
最初に提出
2017年2月10日
QC基準を満たした最初の提出物
2017年3月17日
最初の投稿 (実際)
2017年3月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月23日
QC基準を満たした最後の更新が送信されました
2017年3月17日
最終確認日
2017年3月1日
詳しくは
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。