Relapsed Malignant Blood Cancer After Allogeneic Hematopoietic Stem Cell Transplantation
Stopped early
Conditions studied: Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Hodgkins Lymphoma, Non-Hodgkins Lymphoma
In brief
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: * To develop a systematic, comprehensive evaluation of individuals with relapsed malignant blood cancers after allotransplant (and, if available, their donors) to identify potential treatment study options * To compare the immune system after allotransplant between people whose cancers are growing with people whose cancers remain in remission. * To compare the immune system after cancer relapse/progression treatment between people whose cancer responds to treatment with those whose cancers continue to grow. Eligibility: * Individuals whose blood system cancer grows or comes back after receiving allotransplant treatment. * Individuals whose blood system cancer is responding or in remission 100 days or more after receiving allotransplant treatment. * Related stem-cell donors of eligible allotransplant recipients. Design: * Participants will be evaluated with a full physical examination, detailed medical history (for recipients, including a history of allotransplant treatment process, side-effects, etc.), and blood tests. Recipients will also have imaging studies, possible tissue biopsies, quality of life questionnaires/assessments, and other tests to evaluate the current state of their cancer, whether active or in remission. In some cases, it may be possible to substitute results from recent tests and/or biopsies. * Healthy related donors will have apheresis to provide white blood cells for study and/or for use in potential treatment options. If stem cells would be medically helpful to a recipient, their donors might be asked to take injections of filgrastim before the apheresis procedure to stimulate the production of stem cells for collection. * As feasible, all recipients will be asked to return to the NIH for detailed follow-up visits in conjunction with 6, 12, and 24 months post-allotransplant evaluations, and may be monitored between visits. * Recipients whose cancers are active and who are found to be eligible for treatment protocols at the NIH will continue to be monitored on this study while participating on treatment protocols. Return visits and follow-up tests for this study will be coordinated with those required by the treatment protocol. * Participants may return in the future to be evaluated for new treatment study options (recipients) or additional cell donations for therapy (donors).
Key facts
- Study ID
- NCT01326728
- Run by
- National Cancer Institute (NCI)
- People needed
- 56
- Starts
- 2011-03-30
- Expected to finish
- 2017-07-14
- Last updated by the study team
- 2018-06-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- RECIPIENT SUBJECTS:
- Individuals with rapid disease progression or aggressive cancer histology who, in the opinion of the PI/Designee, require urgent therapy within 30 days in order to preserve organ function or quality of life. This restriction will not apply if there is no approved therapy with a reasonable chance of disease response, if the patient does not have access to an effective therapy and the patient appears to be eligible for an accruing CC treatment protocol or if the patient is enrolled on an NIH/CC clinical protocol, e.g., allotransplant protocol.
- Pregnancy or lactating. Additionally, Recipient-Subjects of childbearing potential that will receive cancer treatment under this protocol must be willing to use an effective method of contraception.
- DONOR SUBJECTS:
- Adult donors who are not eligible for clinical donation will not be excluded from study participation, but will only be able to donate cells for research.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.