Clinical Evaluations and Laboratory Studies in Patients With Chronic Graft-Versus-Host Disease Who Have Undergone a Previous Donor Stem Cell Transplant - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00331968

Purpose

RATIONALE: Gathering information about patients with chronic graft-versus-host disease who have undergone a previous donor stem cell transplant may help doctors learn more about the disease and find better methods of treatment and on-going care.

PURPOSE: This natural history study is collecting health information from patients with chronic graft-versus-host disease who have undergone a previous donor stem cell transplant.

Condition	Intervention
Cancer	Other: laboratory biomarker analysis Other: physiologic testing Procedure: biopsy Procedure: management of therapy complications

Study Type:	Observational
Official Title:	Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Hodgkin Disease Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival as assessed by Kaplan-Meier
Graft-vs-host disease (cGVHD)-specific survival (until death due to cGVHD) as assessed by Kaplan-Meier
Time until removal of immunosuppressive drugs
Need for new form of systemic therapy
Time to discontinue systemic steroids
Therapeutic failure (need for new form of therapy or death)
Progression of underlying disease
Return to a full time job

Estimated Enrollment:	360
Study Start Date:	September 2004

Detailed Description:

OBJECTIVES:

Establish a multidisciplinary clinic infrastructure for studying pathogenesis and the natural history of chronic graft-vs-host disease (cGVHD).
Determine candidate markers for clinical and biological prognostic factors in patients with cGVHD after allogeneic hematopoietic stem cell transplantation.
Develop a prognostic model using patient survival and being permanently off immunosuppressive drugs for ≥ 3 months 2 years after study entry as the primary endpoint.
Develop clinically relevant cGVHD grading scales.
Determine novel biological characteristics of cGVHD and describe them in the context of clinical history and presentation.
Determine potential clinical and biological markers of cGVHD activity.
Improve current understanding of the biology of cGVHD-associated graft-vs-tumor effects.

OUTLINE: This is a prospective, natural history, retrospective, longitudinal data collection study.

Patients referred for evaluation of chronic graft-vs-host disease (cGVHD) undergo a clinical and laboratory multispecialty diagnostic evaluation that includes blood collection and biopsies. A summary of the multidisciplinary evaluation and recommendations are conveyed to the patient and primary physician. Selected clinical outcomes data is collected from patients by telephone and mail (i.e., interviews and questionnaires) every 6 months for 3 years and then annually for up to 10 years if chronic GVHD is confirmed or cannot be ruled out.

Patients may undergo additional blood collection and tissue biopsies periodically for biomarker correlative studies.

PROJECTED ACCRUAL: A total of 290 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	1 Year to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of chronic graft-vs-host disease (cGVHD)*, independent of underlying diagnosis, meeting the following criteria:
- Presence of ≥ 1 clinical manifestation that is distinct for cGVHD
- No infection, drug reaction, or recurrent malignancy
- Tissue biopsy of ≥ 1 involved organ compatible with cGVHD, if medically possible
- Autoimmune phenomena or entities not sufficient by itself for diagnosis of cGVHD (e.g., bronchiolitis obliterans, myositis, immune thrombocytopenic purpura, glomerulopathy, myasthenia, or serositis) need ≥ 1 other typical clinical manifestation distinct for cGVHD and/or a biopsy consistent with cGVHD 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 cGVHD is reliably excluded on the basis of clinical assessments in the cGVHD clinic
Received prior allogeneic hematopoietic stem cell transplantation
Prior nonmalignant diagnosis is allowed if patient has cGVHD (e.g., aplastic anemia)

PATIENT CHARACTERISTICS:

Life expectancy ≥ 3 months
No significant medical condition or circumstance that would affect the patient's ability to tolerate, comply, or complete the study

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331968

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937
United States, New Jersey
Hackensack University Medical Center Cancer Center	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Steven Z. Pavletic, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Web site for additional information This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

Clark J, Yao L, Pavletic SZ, Krumlauf M, Mitchell S, Turner ML, Cowen EW. Magnetic resonance imaging in sclerotic-type chronic graft-vs-host disease. Arch Dermatol. 2009 Aug;145(8):918-22.

Imanguli MM, Swaim WD, League SC, Gress RE, Pavletic SZ, Hakim FT. Increased T-bet+ cytotoxic effectors and type I interferon-mediated processes in chronic graft-versus-host disease of the oral mucosa. Blood. 2009 Apr 9;113(15):3620-30. Epub 2009 Jan 23.

Study ID Numbers:	CDR0000393835, NCI-04-C-0281
Study First Received:	May 30, 2006
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00331968 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis

chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Lymphoma, Large-Cell, Immunoblastic
Graft vs Host Disease
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on February 09, 2010