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Graft-Versus-Host Disease

A Randomized Phase II Single-Center Study of Pomalidomide for Chronic Graft-Versus-Host Disease (GvHD)

NCI-12-C-0197, NCT01688466

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Investigator(s):

Steven Z. Pavletic, M.D., M.S.
Principal Investigator
Phone: 301-402-4899
Fax: 301-451-5578
pavletis@mail.nih.gov

Referral Contact(s):

Kristen Cole, R.N., B.S.N., O.C.N.
Research Nurse Specialist
Phone: 301-451-6569
colekr@mail.nih.gov

Zetta Blacklock, R.N., B.S., B.S.N.
Transplant Coordinator
Phone: 301-594-2056
Fax: 301-451-5578
bblacklock@mail.nih.gov

Sheila Phang, R.N., M.S.
Transplant Coordinator
Phone: 301-435-9379
Fax: 301-451-5578
sphang@mail.nih.gov

 

Key Eligibility Criteria:

  • 18–75 years of age
  • Diagnosis of moderate or severe chronic graft-versus-host disease (cGvHD) after allogeneic HSCT
  • cGvHD that did not respond to high-dose corticosteroids (average 0.5 mg/kg/d prednisone for > 8 weeks) or second-line systemic therapy
  • Karnofsky performance score ≥ 60%
  • Not pregnant or breast feeding
  • Women of childbearing potential and men must agree to use effective forms of contraception
  • No hypersensitivity to thalidomide, lenalidomide or pomalidomide
  • No serious medical condition that places the subject at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study Outline:

  • Screening with a physical examination, medical history, blood and urine tests, lung function test and imaging studies
  • Eligible participants will take pomalidomide capsules once a day for 4-week periods called cycles
  • Treatment will be monitored with frequent blood tests; imaging studies; saliva samples, skin and mouth tissue biopsies will also be collected during treatment
  • Treatment will continue for six cycles (6 months), unless the cGvHD gets worse or side effects are too severe
  • If the cGvHD has improved at the end of the six cycles, participants may be able to continue to take pomalidomide for up to six more cycles

Additional Information:

  • This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
  • There is no charge for medical care received at NIH Clinical Center.
  • PDQ (Physicians Data Query) - provides additional details about this study for health care providers.


Reviewed: 
Updated: 11/14/12

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