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Natural History Study of Clinical and Biological Factors in Patients With Chronic Graft-Versus-Host Disease After Prior Allogeneic Hematopoietic Stem Cell Transplantation
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Clinical Evaluations and Laboratory Studies in Patients With Chronic Graft-Versus-Host Disease Who Have Undergone a Previous Donor Stem Cell Transplant
Basic Trial Information
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Protocol IDs
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No phase specified
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Biomarker/Laboratory analysis, Natural history/Epidemiology
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Active
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1 to 75
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NCI
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NCI-04-C-0281 NCT00331968
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Special Category:
NIH Clinical Center trial, NCI Web site featured trial 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.
Entry Criteria Disease Characteristics:
- Diagnosis of chronic graft-vs-host disease (cGVHD)*, independent of underlying diagnosis, meeting the following criteria:
- Received prior allogeneic hematopoietic stem cell transplantation
- Prior nonmalignant diagnosis is allowed if patient has cGVHD (e.g., aplastic anemia)
Prior/Concurrent Therapy:
- See Disease Characteristics
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
Expected Enrollment 290A total of 290 patients will be accrued for this study. Outcomes Primary Outcome(s)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
Outline This is a prospective, natural history, 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.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research-Medical Oncology | | | Steven Pavletic, MD, Principal investigator | | | | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
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New Jersey |
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Hackensack |
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| | | Hackensack University Medical Center Cancer Center |
| | Clinical Trials Office - Hackensack University Medical Center Cancer Center | |
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Related Information Web site for additional information Featured trial article
Registry Information | | Official Title | | Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease | | Trial Start Date | | 2004-09-28 | | Registered in ClinicalTrials.gov | | NCT00331968 | | Date Submitted to PDQ | | 2004-09-28 | | Information Last Verified | | 2006-09-20 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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