A Pilot Study of Lenalidomide Alternating With Ipilimumab Post Allogeneic and Autologous Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant
研究概览
简要总结
This pilot clinical trial studies the side effects of lenalidomide and ipilimumab after stem cell transplant in treating patients with hematologic or lymphoid malignancies. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide with ipilimumab may be a better treatment for hematologic or lymphoid malignancies.
详细描述
PRIMARY OBJECTIVES:
I. To assess the safety of lenalidomide in combination with ipilimumab in autologous and allogeneic stem cell transplantation.
SECONDARY OBJECTIVES:
I. Overall response rate. II. Overall survival, progression-free survival. III. Cumulative incidence of acute and chronic graft-versus-host disease (GVHD) with the competing risk of relapse in allogeneic transplant patients.
OUTLINE:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hematologic or lymphoid malignancy
- •Autologous patients can be included anytime within 6 months post-transplant, if they had no signs of progression and meet one of the following criteria: i. leukemia; ii. lymphoma (all types of B and T cell lymphoma); iii. multiple myeloma
- •Allogeneic patients if: i. patients had engrafted donor cells (i.e., > 20% donor T-cell from peripheral blood [PB]/polymerase chain reaction [PCR]); and, ii. patients NOT in complete remission (CR) after their allogeneic transplant, and off tacrolimus and/or mycophenolate mofetil for at least 3 to 4 weeks with no signs of GVHD; or, iii. patients had evidence of relapse after their transplant who are off tacrolimus and/or mycophenolate mofetil or other immunosuppressants for GVHD for 3 to 4 weeks with no signs of GVHD (prednisone doses =< 10 mg are permitted as stated previously)
- •No active infection
- •Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
- •Platelets > 75 x 10^9/L
- •Able to adhere to the study visit schedule and other protocol requirements
- •Performance status: Eastern Cooperative Oncology Group (ECOG) 2 or less or Karnofsky of at least 60
- •Cardiac ejection fraction (EF) >= 45% by 2-dimensional echocardiogram (2D-ECHO) within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
- •Forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO) >= 40% within 3 months of study entry (or within 1 month if received chemotherapy within the past 3 months)
- •Serum creatinine =< 1.6 mg/dL and creatinine clearance >= 30 ml/min; creatinine clearance will be calculated using the Cockcroft-Gault equation
- •Serum glutamate pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase (SGOT) less than 2 x the upper limit of normal range (unless related to Gilbert's disease or medications)
- •Direct bilirubin < 1.6 (unless related to Gilbert's disease or medications)
- •Patient or legally authorized representative able to sign informed consent
- •Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to study entry
排除标准
- •Immunotherapy or chemotherapy with approved or investigational anticancer therapeutics within 4 weeks of first dose
- •Patients on alemtuzumab within 6 weeks prior to consenting
- •Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia or conduction abnormalities uncontrolled by conventional interventions; myocardial infarction within 6 months of study entry
- •Deep vein thrombosis or pulmonary embolism within 3 months of study entry
- •Pregnant or breast-feeding females; (lactating females must agree not to breast-feed while taking lenalidomide)
- •Acute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first dose
- •Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen [Sag] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed)
- •Patients with other known malignancies within the past three years except: i. adequately treated basal or squamous cell skin cancer; ii. carcinoma in situ of the cervix; iii. prostate cancer with Gleason score < 6 with stable prostate-specific antigen (PSA) over the past three months; iv. breast cancer in situ with full surgical resection
- •Significant neuropathy (grades 3 to 4 or grade 2 pain)
- •Known hypersensitivity to thalidomide, lenalidomide or ipilimumab
- •Active life-threatening autoimmune disease
- •Active GVHD or recent GVHD and still on > 10 mg prednisone (or equivalent)
- •Prior auto-immune disease
研究组 & 干预措施
Treatment (lenalidomide and ipilimumab)
Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Ipilimumab (Biological)
Treatment (lenalidomide and ipilimumab)
Patients receive lenalidomide PO QD on days 1-21 of courses 1, 3, 5 and 7. Beginning 1-3 days after the last dose of lenalidomide patients receive one dose of ipilimumab IV over 90 minutes of courses 2, 4, 6 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Number of Participants Experienced Severe Toxicity From Lenalidomide and Ipilimumab Post Transplant
时间窗: Up to 30 days following the last dose of study drugs
Any grade 4 hematological toxicity or grade 3-5 organ toxicity 30 days following the last dose of study drug.
次要结局
- Number of Participants Achieved Complete Remission(Up to 30 days following the last dose of study drug)
- Progression-free Survival(Up to 36 months)