Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)
This study has been terminated.
(Terminated due to slow accrual.)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: May 7, 2008
Last updated: August 24, 2011
Last verified: August 2011
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.
- 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
- 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase II Study of Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Versus-Host Disease (GVHD)
Primary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- ECOG performance status </= 2.
- WBC >/= 2,500/mm^3, ANC >/= 1,000/mm^3, platelet count >/= 50,000/mm^3
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrythmias or symptomatic heart disease. FEV1, FVC and DLCO >/= 40%.
- Serum creatinine <2.0 mg/dL. Serum bilirubin <3 X upper limit of normal, AST (SGOT) and ALT (SGPT) < or = 5 x 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).
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675441
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Amin Alousi, MD
||M.D. Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 7, 2008
||August 24, 2011
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Chronic Graft-versus-Host Disease
Stem Cell Transplant
Allogeneic hematopoietic stem cell transplantation
Post-Transplant Prophylactic Immunosuppressive Therapy
Standard-of-care steroid treatment
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Graft vs Host Disease
Immune System Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents