Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)

Graft-versus-Host Disease Clinical Trial

Official title: A Phase II Study of Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Versus-Host Disease (GVHD)

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

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.

Study Drug Administration:

You will swallow lenalidomide capsules whole with water (about 16 ounces) at the same time each day. You should not break, chew, or open capsules. If you miss a dose of lenalidomide, you should take it as soon as you remember on the same day. If you miss taking your dose for the entire day, you will take your regular dose the next day ( DO NOT take double your regular dose to make up for the missed dose).

Study Visits:

During treatment, you will have additional testing to check for side effects and to learn your body's response to therapy. You will have these tests every 2 weeks (during Cycles 1 and 2), once a month (during Cycles 3-6), and every 3 months for up to 1 year from when you started treatment with the study drug.

• You will have a physical exam.

• You will have a full skin assessment. For this assessment, the study doctor will look at your skin to see if your skin shows a reaction to the cGVHD transplant.

• You will have a 2-minute walking test. For this test, you will be asked to walk for 2 minutes, and your walking distance will be measured.

• You will have a grip strength test. For this test, you will be asked to sit down and squeeze something that has a meter to measure your strength.

• You will complete some questionnaires about how you are feeling physically, emotionally, and socially. It should take about 20 minutes to complete.

• You will complete another questionnaire about how you assess your symptoms. It should take about 20 minutes to complete.

• You will have blood drawn (about 2 tablespoons) for routine tests and to check immune-suppressive drug (such as tacrolimus or cyclosporine) levels in your blood.

• You will be asked about how you are feeling and about any side effects you may have experienced since your last visit.

Females who are able to have children that have regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at the end of the study, and 28 days following the end of the study. If your menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.

Your dose of the study drug will be temporarily stopped or decreased if the study doctor thinks it is necessary for your safety. Other drugs may also be given to you to help decrease side effects. The study doctor will tell you what these drugs will be if this is necessary.

Length of Study:

You will be taken off this study if the disease gets worse or you experience any intolerable side effects. If you are tolerating and responding to the study treatment, you will be on this study for up to 1 year from enrollment.

This is an investigational study. Lenalidomide is FDA approved and commercially available for the treatment of specific types of myelodysplastic syndrome (MDS). It is also approved in combination with dexamethasone for previously treated multiple myeloma. Its use in this study is investigational and authorized for use in research only. Up to 46 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-Host Disease

• NCT number: NCT00675441
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: April 2008
• Completion date: August 2011