NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

04-C-0281

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 1 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Adults who are or may become unable to consent;
Non-English Speaking;
Pregnant Women

Keywords

cGVHD-associated graft-versus-tumor effects (GVT);
Allo-HSCT controls;
Leukapheresis;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Chronic Graft vs. Host Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

-Chronic graft-versus-host disease (cGVHD) is a multi-organ alloimmune and autoimmune disorder that occurs following allogeneic hematopoietic stem cell transplantation (alloHSCT). It is characterized by immune dysregulation, immunodeficiency, impaired organ function, and decreased survival.

-Each year about 8000 patients receive allogeneic hematopoietic stem cell transplant (alloHSCT) in North America and about 50% of patients who are transplanted develop cGVHD.

-Chronic GVHD is also a disorder that simultaneously affects many organ systems in highly variable fashion and requires complex and coordinated medical management by multiple medical specialties. There is an urgent need for progress in understanding and effective treatments for cGVHD as it is one of the most serious complications of cancer therapy and hematopoietic stem cell transplantation.

Objectives:

-To establish a multidisciplinary clinic infrastructure for study of the pathogenesis and natural history of cGVHD.

-To prospectively identify clinical and biological prognostic markers in patients with cGVHD

-To develop clinically relevant cGVHD grading scales

-To identify novel biological characteristics of cGVHD and to describe them in the context of clinical history and presentation

-To identify potential clinical and biological markers of cGVHD activity

-To improve understanding of the biology of cGVHD-associated graft-versus-tumor effects

-To identify potential patients for cGVHD treatment protocols at the NCI and NIH

Eligibility:

-Patients age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independent of underlying diagnosis.

Design:

-Patient undergoes initial clinical and laboratory multispecialty work-up at the NCI cGVHD clinic.

-Minimally invasive biopsies and rarely, deep tissue biopsy may be obtained to confirm the diagnosis and/or rule-out other pathologic process (in adults only).

-Long tem data collection for evaluation of long-term outcomes will be conducted anually as feasible

--Back to Top--

Eligibility

INCLUSION CRITERIA:

a) Any patient age 1 and older referred by the primary transplant physician for the evaluation of chronic graft-versus-host disease independently of age or underlying diagnosis

b) Patient or the patient's legal representative is able and willing to provide consent.

EXCLUSION CRITERIA:

a) Significant medical condition or any other significant circumstance that could in the PIs assessment affect the patient's ability to tolerate, comply, or complete the study

b) Patients who in the PIs assessment have a life expectancy less than 3 months.

Note: Because it is not always possible to make a clear clinical distinction between acute and chronic GVHD, patients with acute GVHD are not a-priori excluded until the possibility of chronic GVHD is reliably excluded on the basis of the clinical assessments in the cGVHD clinic.

c) Pregnant women are excluded from this study because multiple tests would need to be excluded for safety of the patient and the fetus.


--Back to Top--

Citations:

Not Provided

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Steven Z. Pavletic, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3130
10 CENTER DR
BETHESDA MD 20892
(240) 760-6174
sp326h@nih.gov

Steven Z. Pavletic, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3130
10 CENTER DR
BETHESDA MD 20892
(240) 760-6174
sp326h@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT00092235

--Back to Top--