A Phase II Trial of Revlimid® (Lenalidomide) and Low Dose Vidaza® (Azacitidine) in Patients With Low - Intermediate-1 Risk Myelodysplastic Syndromes
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Revlimid and Azacitidine Combination
研究概览
简要总结
This phase II study will evaluate the safety and efficacy of combining two active agents;Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) for the treatment of patients with low to intermediate-1 MDS excluding patients with 5 q deletion. The rationale for adding Vidaza® (azacitidine) after 3 months of revlimid monotherapy is that combination therapy will result in higher response rates, and potentially longer response duration than that achieved with either agent.
STUDY OBJECTIVES:
Primary:
To determine the safety and tolerability of the combination of Revlimid® (lenalidomide) and low dose Vidaza® (azacitidine) in patients with low - intermediate-1 risk MDS non 5 q deletion who have not responded after 3 months of Revlimid® (lenalidomide) monotherapy
Secondary:
To determine the response rate in patients with low - intermediate-1 risk MDS non 5 q deletion receiving Revlimid® (lenalidomide) in combination with low dose Vidaza® (azacitidine), as defined by the IWG 2006 Revised Response Criteria
详细描述
Eligibility criteria
- Understand and voluntarily sign an informed consent form.
- Age 18 years at the time of signing the informed consent form.
- Able to adhere to the study visit schedule and other protocol requirements.
- Diagnosis of low- or intermediate-1-risk IPSS (see Appendix III) MDS without an abnormality of chromosome 5 involving a deletion between bands q31 and q33.
Pathologic diagnosis via pathology performed at Rush University Medical Center or made available to Rush from outside institution. 5. Prior treatment with < 3 cycles (84 days) of Revlimid® (lenalidomide) are eligible for enrollment regardless of response. 6. ECOG performance status of 2 at study entry (see Appendix II). 7. Disease free of prior malignancies for > 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast. 8. Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis. 9. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN. 10. Serum creatinine levels < 1.5 x ULN 11. Absolute neutrophil count > 1000/mm³ 12. Platelet count > 30,000/mm³ 13. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low to Int-1 risk MDS
- •ECOG performance status of < 2 at study entry (see Appendix II).
- •Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast.
- •Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
- •Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
- •Serum creatinine levels 1.5 x ULN
- •Absolute neutrophil count > 1000/mm³
- •Platelet count > 30,000/mm³
- •All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
- •Females of childbearing potential (FCBP)† must have a negative serum or urine
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide).
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Use of any other experimental drug or therapy within 28 days of baseline.
- •Known hypersensitivity to lenalidomide, azacitidine, or mannitol.
- •Any prior use of Vidaza® (azacitidine).
- •Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
- •Concurrent use of other anti-cancer agents or treatments.
- •Known positive for HIV or infectious hepatitis, type B or C.
研究组 & 干预措施
lenalidomide and azacitidine combination
Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.
干预措施: Lenalidomide and azacitidine combination (Drug)
结局指标
主要结局
Safety and Tolerability of Revlimid and Azacitidine Combination
时间窗: Study was closed and outcome unable to be measured.
To determine the number of subjects who develop grade 4 toxicity while on combination therapy.
次要结局
未报告次要终点
研究者
Jamile Shammo
Associate Professor of Medicine and Pathology
Rush University Medical Center