A Phase II Study of Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Versus-Host Disease (GVHD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of Participants' With Treatment Response of Complete or Partial Response
研究概览
简要总结
The goal of this clinical research study is to learn if Revlimid® (lenalidomide), along with standard-of-care steroid treatment you are already receiving, can help to control Chronic Graft-Versus-Host Disease (cGVHD). The safety of this study drug in combination with the steroids will also be studied.
Primary Objectives:
- To assess the response rate of chronic GVHD to Lenalidomide after failing steroids
- To evaluate the safety and tolerability of Lenalidomide in patients with chronic GVHD
Secondary Objectives:
- To assess the steroid-sparing capacity of Lenalidomide (as proportion of patients able to discontinue steroids while receiving or following therapy with Lenalidomide)
- To assess changes in QOL after treatment with Lenalidomide
- To analyze survival at 6 and 12 months after initiation of Lenalidomide
- To evaluate relapse of underlying malignancy as well as second malignancies at 6 and 12 months after initiation of Lenalidomide
详细描述
The Study Drug:
Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. It may decrease or prevent the growth of cancer cells.
Researchers want to find out if lenalidomide can improve the cGVHD and if it can help decrease the amount of steroids you need, which may help prevent long-term side effects that occur when steroids are used over a long period of time.
Study Treatment:
If you are found to be eligible to take part in this study, you will take lenalidomide by mouth (1 larger-dose capsule or 2 smaller-dose capsules) once daily for 21 days followed by 7 days without treatment (a "rest period"). Each 28-day period is called a cycle of therapy. You will have up to 6 cycles of therapy on this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic GVHD following allogeneic HSCT of any source (bone marrow, peripheral blood or cord blood stem cells), from any donor type (related, unrelated, mismatched) and with any type of malignancy.
- •Patients must have failed a trial of steroids and calcineurin inhibitors. Steroids must have been given at an initial dose of 1 mg/kg/d of methylprednisolone (MP) or equivalent in combination with tacrolimus or cyclosporine. Steroid refractoriness or resistance will be defined as: 1- Lack of any response after 1 month of treatment with MP, including 15 days of at least 0.5 mg/kg/d, 2- Worsening of existing GVHD or new organ involvement at any time following one week of initiation of MP at 1 mg/kg/day, 3- Reflare or worsening of GVHD at any time during steroid taper.
- •Patients may have received steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus) for chronic GVHD. Patients who have previously been treated for chronic GVHD with any other drug or treatment may be enrolled, provided the other drug or treatment was completed >/= 30 days before registration for study entry.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •White Blood Count (WBC) >/= 2,500/mm^3, Absolute neutrophil count (ANC)>/= 1,000/mm^3, platelet count >/= 50,000/mm^3
- •Left ventricular ejection fraction >/= 40%. No uncontrolled arrythmias or symptomatic heart disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%.
- •Serum creatinine <2.0 mg/dL. Serum bilirubin <3 * upper limit of normal (ULN), aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transminase (SGOT) and Alanine transaminase (ALT)/ serum glutamic pyruvic transaminase (SGPT) < or = 5 * ULN. No evidence of chronic active hepatitis or cirrhosis.
- •No uncontrolled infections.
- •No evidence of malignancy (patients must be in complete remission from their malignancy)
- •Patients must be able to provide written informed consent, and be 18 years or older at the time of signing consent.
- •Patient must be able to return to clinic for follow up at least every 2 weeks for the first 2 months and at least monthly thereafter.
- •Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or agree to use 2 contraceptive methods. These birth control methods must be used for at least 4 weeks before, during and after lenalidomide therapy. Men must agree not to father a child and agrees to use a condom if his partner is of child bearing potential.
- •Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).
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 lactating females.
- •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 thalidomide.
- •The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- •Any prior use of Lenalidomide.
- •Use of prior immunosuppressants other than steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus).
- •Known positive for HIV or infectious hepatitis, type A, B or C
研究组 & 干预措施
Lenalidomide
Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Number of Participants' With Treatment Response of Complete or Partial Response
时间窗: Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days.
Treatment responses defined as complete (CR) or partial organ response (PR) of chronic Graft-Versus-Host Disease (GVHD) to lenalidomide. Complete organ response (CR) indicates resolution of all reversible manifestations related to chronic GVHD in a specific organ. Partial organ response (PR) requires at least 50% improvement in scale used to measure disease manifestations related to chronic GVHD. Tools for response evaluation were skin assessment and functional assessment including minute walk and grip strength.
次要结局
未报告次要终点