A replacement protocol was created to replace this current version of protocol.
Study of the Biology and Natural History of Disease Outcomes in Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation for Hematologic Malignancies
Sponsor study identifier
Secondary identifiers
observational
56
1 country
1
Study Start
March 30, 2011
Actual (reported)Primary Completion
June 28, 2017
Actual (reported)Study Completion
July 14, 2017
Actual (reported)Background: Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem cells) have been used with varying degrees of success as an immune therapy for blood-system cancers (leukemias, myelodysplastic syndrome, lymphomas, multiple myeloma, etc.). Some people s cancer remains active (comes back or continues to spread) after an allotransplant, while other peoples cancer disappears and they are hopefully cured. National Institutes of Health (NIH) researchers are studying the reasons for these different treatment outcomes, and trying to develop better cancer treatments for people with active cancer after allotransplant. Researchers are collecting data from people who have had allotransplants for a cancer of the blood, whether or not the cancer is in remission, and from their donors. Those with active cancers may be eligible to participate in one of several NIH studies testing treatments for active cancer after allotransplant. Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 14, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 30, 2011
Actual (reported)March 30, 2011
Actual (reported)March 31, 2011
Actual (reported)June 28, 2017
Actual (reported)July 14, 2017
Actual (reported)June 6, 2018
Actual (reported)Immune Suppression
Biological response to agents and or treatments that can lead to bone marrow suppression/ cytopenias and sometimes death.
up to 100 days or more following transplant
Time to Progression After Allotransplant
Time to Progression is the time between the first day of treatment to day 100 after allotransplant.
first day of treatment to day 100 after allotransplant
Overall Survival
Overall Survival is the time between the first day of treatment to the day of death.
first day of treatment to the day of death
Allogeneic hematopoietic stem cell transplantation (or allotransplant; donor blood stem cells)
Donors will undergo cell collection and recipients will receive cells (allotransplant).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Individuals aged 18-99 who are being enrolled on Clinical Center protocols to undergo allotransplant therapy for hematologic malignancies. The population will consist of those that have received allotransplant treatment for hematologic malignancy, are in remission either at or after Day 100, have malignancy progression or persistently stable disease post allotransplant, or the related donor of eligible allotransplant recipients.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Pavletic SZ, Kumar S, Mohty M, de Lima M, Foran JM, Pasquini M, Zhang MJ, Giralt S, Bishop MR, Weisdorf D. NCI First International Workshop on the Biology, Prevention, and Treatment of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation: report from the Committee on the Epidemiology and Natural History of Relapse following Allogeneic Cell Transplantation. Biol Blood Marrow Transplant. 2010 Jul;16(7):871-90. doi: 10.1016/j.bbmt.2010.04.004. Epub 2010 Apr 24.
Dazzi F, Fozza C. Disease relapse after haematopoietic stem cell transplantation: risk factors and treatment. Best Pract Res Clin Haematol. 2007 Jun;20(2):311-27. doi: 10.1016/j.beha.2006.10.002.
Blood and tissue specimens collected in the course of this research project may be cryopreserved and used in the future to investigate new scientific questions related to the study.
Ronald E Gress, M.D.
National Cancer Institute (NCI)
56 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2011
First Posted
March 31, 2011
Study Start
March 30, 2011
Actual (reported)Days to Engraftment
Number of days for a participant to reach engraftment.
up to 100 days or more following allotransplant
Count of Participants With Acute Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant
Acute GVHD is defined as GVHD that presents with signs and symptoms typical of acute GVHD but presenting after day 100 post allotransplant. Clinical Staging Grade 2 ((+) to (+++) Skin; (+) Liver; and (+) Gut) involvement, Grade 3 ((++) to (+++) Skin; (++ to +++) Liver; and (++ to +++) Gut) involvement, and Grade 4 ((++) to (++++) Skin; (++ to ++++) Liver; and (++ to ++++) Gut) involvement.
100 days or more post allotransplant
Count of Participants With Chronic Graft Versus Host Disease (GVHD) Grade 2 or More 100 Days Post Allotransplant
Mild chronic GVHD involves only 1 or 2 organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites). Moderate GVHD involves at least 1 organ or site with clinically significant but no major disability (max. score of 2 in any affected organ or site), or 3 or more organs or sites with no clinically significant functional impairment (max. score of 1 in all affected organs or sites), and a lung score of 1 will also be considered moderate chronic GVHD. Severe chronic GVHD indicates major disability caused by chronic GVHD (score of 3 in any organ or site). A lung score of 2 or greater will also be considered severe chronic GVHD.
100 days post allotransplant
Count of Participants With Infection After Allotransplant
Count of Participants with Infection After Allotransplant.
up to 100 days or more post allotransplant
Number of Participants With Serious and Non-Serious Adverse Events
5 years
Count of Participants With Clinical Blood Markers of Inflammation
up to 100 days or more following allotransplant
Regimen-Specific Sensitivity After Allotransplant
up to 100 days or more following allotransplant
Tumor Immune Response Graft-Versus-Leukemia (GVL)
up to 100 days or more following allotransplant
Contact the study team to confirm eligibility.
Porter DL, Alyea EP, Antin JH, DeLima M, Estey E, Falkenburg JH, Hardy N, Kroeger N, Leis J, Levine J, Maloney DG, Peggs K, Rowe JM, Wayne AS, Giralt S, Bishop MR, van Besien K. NCI First International Workshop on the Biology, Prevention, and Treatment of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation: Report from the Committee on Treatment of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2010 Nov;16(11):1467-503. doi: 10.1016/j.bbmt.2010.08.001. Epub 2010 Aug 10.
Primary Completion
June 28, 2017
Actual (reported)Study Completion
July 14, 2017
Actual (reported)Last Updated
June 6, 2018
Results First Posted
June 6, 2018
Record last verified: 2018-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: