Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia
Lenalidomide for the Treatment of CLL Patients With High-Risk Disease
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the time to progression in patients with high-risk chronic lymphocytic leukemia (CLL) treated with lenalidomide.
SECONDARY OBJECTIVES:
I. To determine the clinical response (complete and partial response) in treatment-naïve patients with high-risk CLL treated with single-agent lenalidomide.
II. To determine the incidence of immune-mediated flare reaction. III. To determine the toxicity profile of single-agent lenalidomide in previously untreated patients with high-risk CLL.
IV. To conduct correlative studies in bone marrow, peripheral blood, and/or lymph nodes of patients treated with lenalidomide.
OUTLINE:
Patients receive oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses. Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.
After completion of study therapy, patients are followed up every 3 months for a maximum of 5 years.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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New York
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Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
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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:
Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
Must have high-risk B-CLL as defined by ≥ one of the following:
- High-risk cytogenetics (either 17p deletion and/or 11q deletion)
- Unmutated immunoglobulin heavy chain gene rearrangement
- Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
- No prior treatment for the management of B-CLL
- Patients must have B-CLL requiring therapy as defined by the IWCLL criteria
Must have measurable disease meeting one of the following criteria:
- Absolute lymphocyte count > 5,000/μL
- Measurable lymphadenopathy or organomegaly
No tumor lysis syndrome (TLS) by Cairo-Bishop definition
- Patients with correction of electrolyte abnormalities allowed
- ECOG performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)
Uric acid normal
- Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
- Able to adhere to the study visit schedule and other protocol requirements
- No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
- No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- No known hypersensitivity to thalidomide or lenalidomide
- No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
- No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years
- No cardiac arrest within the past 6 months
- No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
- No other concurrent anti-cancer agents or treatments
- More than 28 days since any prior experimental drug or therapy
- Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
- No prior lenalidomide
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：非ランダム化
- 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：Arm I
Patients receive oral lenalidomide once daily on days 1-21.
Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve complete response (by morphological criteria but have persistent minimal residual disease by molecular criteria) or partial response may continue treatment beyond 8 courses.
Patients may undergo bone marrow, peripheral blood, and/or lymph node sample collection at baseline and periodically during study for correlative studies.
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相関研究
経口投与
他の名前：
|
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 |
|---|---|
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Time to progression
時間枠：From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months
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From the start of lenalidomide therapy to time of disease progression, assessed up to 24 months
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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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Maximal clinical response (complete and partial response)
時間枠：Up to 24 months
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Summarized by a sample proportion along with the exact 95% confidence interval.
The time-to-progression will be graphically analyzed using standard Kaplan-Meier estimation.
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Up to 24 months
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協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2011-02568 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- P30CA016056 (米国 NIH グラント/契約)
- CDR0000692070
- RPCI # I 174910 (その他の識別子：Roswell Park Cancer Institute)
- 8254 (その他の識別子：CTEP)
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