Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia
Sequential Treatment With Azacitidine and Lenalidomide for Relapsed and Refractory Patients With Acute Myeloid Leukemia
調査の概要
詳細な説明
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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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Cancer Center
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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:
• World Health Organization (WHO)-confirmed AML, other than Acute Promyelocytic Leukemia (APL)
- Age >18 years
White blood cell count (WBC) at initiation of treatment ≤ 10,000/L
o If WBC is > 10,000/L patients may be started on an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC < 10,000/L, at which time the hydroxyurea will be discontinued for 12 hours prior to enrollment
Relapsed or refractory (resistant) disease, as defined by standard criteria21:
- Relapsed: Bone marrow blasts ≥5%; reappearance of blasts in the blood; development of extramedullary disease
- Refractory (resistant): Failure to achieve Complete Remission (CR) or complete remission with incomplete recovery of blood counts (CRi) in patients who survive ≥7 days following completion of initial treatment, with evidence of persistent leukemia by blood and/or bone marrow examination
- Failure of at least one prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix D: ECOG Performance Status Scale)
- Life expectancy > 2 months
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist® (RevAssist is a restricted distribution program for receiving lenalidomide)
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 million International Units per milliliter (mIU/mL) 10 - 14 days prior to study enrollment and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix F: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods
- Willing and able to understand and voluntarily sign a written informed consent
- Able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
• Known or suspected hypersensitivity to azacitidine or mannitol
- Patients with advanced malignant hepatic tumors.
- Treatment less than four weeks prior to enrollment with other experimental therapies or antineoplastic agents, with the exception of hydroxyurea
- Inability to swallow or absorb drug
- Prior treatment with lenalidomide for AML
- Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
- New York Heart Association Class III or IV heart failure
- Unstable angina pectoris
- Significant uncontrolled cardiac arrhythmias
- Uncontrolled psychiatric illness that would limit compliance with requirements
- Known Human immunodeficiency virus (HIV) infection
- Graft vs. host disease ≥ grade 2
- Relapse after allogeneic stem cell transplantation prior to post-transplant day 30
- Pregnant or breast feeding females; lactating females must agree not to breast feed while taking lenalidomide
- Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient's safety or interfere with data interpretation
Laboratory abnormalities:
- Either creatinine >2.0 mg/dL or creatinine clearance <30 mL/min
- Total bilirubin > 2 x institutional upper limit of normal (ULN) (unless documented Gilbert's syndrome)
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) > 3 x institutional ULN
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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実験的:Azacitidine + Lenalidomide + Off Therapy
Patients will receive 7 days of azacitidine followed by 3 weeks of lenalidomide.
They will then have 2 weeks off therapy, for a maximum of 12 cycles.
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Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.
他の名前:
Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.
他の名前:
2 weeks off therapy, then begin sequence again for 12 weeks.
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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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Percentage of Participants With Complete Remission or Complete Remission With Incomplete Recovery Blood Counts
時間枠:Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)
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Change in baseline to end of study.
To be assessed by standard criteria based on bone marrow examination.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Interim assessment after 18 patients (estimated 2 years) and full assessment after 37 patients (estimated 3-4 years)
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Overall Response Rate
時間枠:Planned assessment after enrollment of all 37 patients (estimated 3-4 years)
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Change in baseline to end of study.
To be assessed by standard criteria based on bone marrow examination
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Planned assessment after enrollment of all 37 patients (estimated 3-4 years)
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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 |
---|---|---|
Response or Remission Duration
時間枠:Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
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Change in baseline to end of study.
To be assessed by standard criteria based on bone marrow examination
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Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
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Toxicity and SAEs Related to Treatment
時間枠:Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years
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Change in baseline to end of study.
To be measured based on Common Terminology Criteria for Adverse Events (CTCAE) criteria
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Will begin assessment with first patient and will continue until completion of study, estimated to be 4 years
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Overall Survival
時間枠:Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years
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Change in baseline to end of study
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Depending on outcomes, will begin assessment at 2 years and will continue until completion of study, estimated to be at four years
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Progression-free Survival
時間枠:Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
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Change in baseline to end of study.
To be assessed by standard criteria based on bone marrow examination
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Depending on outcomes, will initiate this assessment after 2 years and will continue until completion of study, estimated at 4 years
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Determine Biomarkers That Predict Response/Toxicity
時間枠:Three years after initiating study
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Change in baseline to end of study.
Planned assessments of methylation changes and other biomarkers.
Computational biology modeling used to identify biomarkers and predict response.
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Three years after initiating study
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協力者と研究者
協力者
研究記録日
主要日程の研究
研究開始 (実際)
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
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