Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Role of Rituximab Containing Salvage Chemotherapy and in Vivo Purging in Obtaining PCR Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma or Transplant Eligible Mantle Cell Lymphoma
調査の概要
詳細な説明
Following the first relapse, patients with follicular type of Non-Hodgkin's lymphoma may have an option to receive high dose chemotherapy followed by autologous (from you) blood stem cell transplantation. One of the common causes of relapse is persistence of lymphoma cells in the bone marrow and in the collected stem cell products.
Patients who do not have a complete response after traditional chemotherapy, have a greater chance of the lymphoma returning even after receiving high dose chemotherapy with stem cell transplantation. In order to improve the response and decrease the relapse rate, additional therapy may be used to kill the lymphoma cells by using antibodies both before and after the transplantation. Antibodies are protein made by white cells in our body to fight off infection and sometimes tumor. Rituxan (rituximab) is an antibody that is effective against your type of lymphoma. Researchers have reported that patients show an improved response and a lower chance of relapse when using rituximab with high dose chemotherapy with autologous stem cell transplantation. It is unknown how effective rituximab is in clearing persistence of minimal remaining disease in patients with follicular lymphoma.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
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Kansas City、Kansas、アメリカ、66205
- University of Kansas Medical Center, Westwood Campus
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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
Inclusion Criteria:
- Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20) Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete remission 1) or later.
- Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow negative disease.
- Patients planning to harvest and hold may also be included as long as above criteria are met.
Exclusion Criteria:
- Pregnancy
- Zubrod performance status greater than 2
- Life expectancy is severely limited by concomitant illness.
- Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation
- Symptomatic pulmonary disease precluding transplantation
- Serum creatinine greater than 1.8 mg/dL
- Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate transaminase) greater than 3 times upper limit of normal
- Evidence of chronic active hepatitis or cirrhosis
- Unable to sign informed consent.
- Allergy to Rituximab
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：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 |
|---|---|
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他の：Rituximab
Patients will be treated IV with rituximab at the rate of 50 milligrams per hour (mg/hour) for 1 hour.
If patient tolerates the infusion, the rate is increased by increments of 50 mg/hour every 30 minutes to a maximum of 400 mg/hour.
If patient has a severe reaction, the infusion is stopped temporarily and the infusion rate is decreased by 50%.
Subsequent infusions are started at the rate of 100 mg/hour, increased by 100 mg/hour every 30 minutes to a maximum of 400 mg/hour if tolerated.
Vital signs are monitored every 15 minutes for 2 hours and every 30 minutes thereafter.
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375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
他の名前：
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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 |
|---|---|---|
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Rate of PCR Negativity
時間枠：up to 7 days
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Number of participants that are tumor free by PCR (Polymerase Chain Reaction) analysis post-transplant.
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up to 7 days
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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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Progression Free Survival (PFS) and Overall Survival (OS)
時間枠：up to 60 months
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Response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) criteria where applicable and/or biopsy proven relapse/progression of disease.
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up to 60 months
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協力者と研究者
捜査官
- 主任研究者：Siddhartha Ganguly, MD、University of Kansas Medical 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 (実際)
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
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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