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.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00675441
First received: May 7, 2008
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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

Condition Intervention Phase
Graft-versus-Host Disease
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Versus-Host Disease (GVHD)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants' With Treatment Response of Complete or Partial Response [ Time Frame: Response assessed after completing 28 day cycle, repeated with each cycle for 6 cycles, approximately 180 days. ] [ Designated as safety issue: No ]
    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.


Enrollment: 5
Study Start Date: April 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide
Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Drug: Lenalidomide
10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.
Other Names:
  • Revlimid
  • CC-5013

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  5. White Blood Count (WBC) >/= 2,500/mm^3, Absolute neutrophil count (ANC)>/= 1,000/mm^3, platelet count >/= 50,000/mm^3
  6. 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%.
  7. 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.
  8. No uncontrolled infections.
  9. No evidence of malignancy (patients must be in complete remission from their malignancy)
  10. Patients must be able to provide written informed consent, and be 18 years or older at the time of signing consent.
  11. 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.
  12. 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.
  13. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).

Exclusion Criteria:

  1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  2. Pregnant or lactating females.
  3. 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.
  4. Use of any other experimental drug or therapy within 28 days of baseline.
  5. Known hypersensitivity to thalidomide.
  6. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  7. Any prior use of Lenalidomide.
  8. Use of prior immunosuppressants other than steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus).
  9. Known positive for HIV or infectious hepatitis, type A, B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675441

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Amin Alousi, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00675441     History of Changes
Other Study ID Numbers: 2006-0321
Study First Received: May 7, 2008
Results First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Chronic Graft-versus-Host Disease
cGVHD
GVHD
Lenalidomide
Revlimid
CC-5013
Stem Cell Transplant
Allogeneic hematopoietic stem cell transplantation
Allogeneic HSCT
HSCT
Post-Transplant Prophylactic Immunosuppressive Therapy
Steroids
Standard-of-care steroid treatment
Corticosteroids
Prednisone
Medrol

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014