Rituximab Maintenance After Autologous Transplantation
Maintenance Therapy With Rituximab After Autologous Transplantation for Non-Hodgkin's Lymphoma
調査の概要
詳細な説明
Rituxan is a mouse antibody that has been changed to make it similar to a human antibody. Antibodies are proteins that can protect the body from foreign invaders, such as bacteria and viruses, by binding to substances called antigens. Rituxan works by binding to a protein, called the CD20 protein (which is found on the surface of normal and cancerous B-lymphocytes). This binding may help to destroy the B-lymphocytes.
Before the study begins, you will have a physical exam, routine blood tests (1-2 tablespoons), and urine tests. Women who are able to have children must have a negative blood pregnancy test. You will also have a chest x-ray and an ECG (test to measure the electrical activity of the heart). The status of the lymphoma will be evaluated by bone marrow biopsy. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle. CT scans and gallium or PET scans will be performed. If you had lymphoma in other areas of your body additional tests may be needed as determined by your treating physician. Tests to evaluate the status of the lymphoma will be repeated before each cycle of chemotherapy. If your white count is low you may need injections of NeupogenTM (growth factor) daily till your white blood cell count is high enough to start the next round of treatment.
You will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive rituximab. Participants in the other group will not receive rituximab. There is an equal chance of being assigned to either group.
Treatment will start between 5-6 months after your stem cell transplant. If you are assigned to the rituximab group, you will receive a total of 4 cycles of treatment. Each cycle will be given 6 months apart. Each cycle is made up of 4 doses of rituximab given once a week for 4 weeks. If the disease returns or intolerable side effects occur while on treatment, you will be taken off the study. You may still be able to receive rituximab outside of this study if your treating physician decided that it is okay.
Treatment will be given on an outpatient basis. The treatment can be given at M. D. Anderson or by your local cancer doctor. Patients who are assigned to the rituximab arm must be willing to get their first and third cycle (all 4 doses) at M. D. Anderson, if their local physician is unable to draw and ship samples to the central laboratory for rituximab levels. Blood will be drawn (approximately one teaspoon) before and after the first and fourth dose and before the second and third dose of those two treatment cycles. The treatment will be given by vein over a period of several hours. Participants who have easily accessible veins may get this treatment by having a temporary needle placed in the vein for the treatment. For participants who do not have easily accessible veins, a central venous catheter (long plastic tube - CVL) will be placed in a big vein of the arm or chest.
Participants who do not receive rituximab will be followed every 6 months at M. D. Anderson as is standard of care.
All participants (even those who do not receive the rituximab) will have to return to M. D. Anderson every 6 months for a period of 3 years (from the date of enrollment) to have the lymphoma evaluated. The status of the lymphoma will be evaluated by blood tests (1-2 tablespoons), CT scans, PET or Gallium scans and bone marrow biopsy.
This is an investigational study. Rituximab has been approved by the FDA. About 90 patients will take part in the study. All will be enrolled at M. D. Anderson.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Texas
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Houston、Texas、アメリカ、77030
- UT MD Anderson Cancer Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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 diffuse large B cell non-Hodgkin's lymphoma who are 5-6 months status post an autologous stem cell transplant and are in CR. Patients who are positive for t(14;18) by PCR or for BCL-2 by Southern blot are eligible provided there is no other disease present.
- Absolute neutrophil count (ANC) > 1500/mm3 independent of growth factor support
- No evidence of symptomatic cardiac or pulmonary disease
- Platelet count > 75,000 mm3
- Zubrod performance status of 2 or less.
- Negative pregnancy test in patients of "child bearing potential"
Exclusion Criteria:
- Uncontrolled active infection
- Severe concomitant medical or psychiatric illness
- Serum bilirubin > 2.0 mg/dl 4) Transaminases > 2xULN 5) Serum creatinine > 2.0 mg/dl
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:ランダム化
- 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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実験的:リツキシマブ
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375 mg/m^2 by vein (IV) in 4 weekly doses (1 cycle) every 6 months for 4 cycles.
他の名前:
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介入なし:No Rituximbab
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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 |
時間枠 |
---|---|
Number of Patients with Progression Free Survival (PFS)
時間枠:2 Years
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2 Years
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協力者と研究者
協力者
捜査官
- スタディチェア:Chitra M. Hosing, MD、UT MD Anderson Cancer Center
出版物と役立つリンク
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
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。
非ホジキンリンパ腫の臨床試験
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Wael Elbanna ClinicFetal Medicine Research Center, Spain募集妊娠する女性: 1- ICSI-PGS 2- ICSI-non-PGS 3- 自然妊娠する女性エジプト
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
Rituximabの臨床試験
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Aprea Therapeutics終了しましたマントル細胞リンパ腫 | 慢性リンパ性白血病 | 非ホジキンリンパ腫アメリカ