Relapsed Hematologic Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation: Screening, Disease Characterization and Natural History
- Cancer relapse is a significant clinical problem following allogeneic hematopoietic
stem cell transplantation (allotransplant), affecting up to half of all patients.
Effective treatment options are extremely limited and, for most cancers, rarely
- Several CC protocols are evaluating treatment for post-allotransplant relapse. Relapse
often progresses quickly; patients require rapid assessment of protocol options in
order to expedite initiation of treatment.
- Basic information is needed to improve management of relapse after allotransplant -
clinical information regarding risk of relapse and cancer behavior after
allotransplant, and information on the biology of relapse after allotransplant - in
order to identify risk factors, target prevention strategies, detect early relapse and
develop effective treatments.
To provide a mechanism for systematic, comprehensive evaluation of individuals with relapsed
hematologic malignancy after allotransplant and, if available, their donors, to streamline
identification of protocol options, enrollment and initiation of therapy.
1. To study the clinical features of relapse after allotransplant.
2. To study biologic features of relapse after allotransplant.
3. To facilitate post-allotransplant clinical care for individuals who received
allotransplant on CC protocols, as a bridge between treatment protocols.
4. To catalogue regimens used to treat relapse, vis-a-vis safety and efficacy, and develop
consensus guidelines for clinical management of relapse after allotransplant.
1. Individuals who have received allotransplant treatment for hematologic malignancy
(Recipient-Subjects). Two comparison cohorts:
1. Relapse Cohort: Cancer progression, relapse or persistently stable (unremitting)
2. Remission (Control) Cohort: Cancer response or remission at/after Day 100
2. Individuals who are candidates for allotransplant therapy for hematologic malignancies
and are being evaluated at the Clinical Center for planned allotransplantation. These
subjects will be subsequently assigned to the Relapse or Remission Cohort by Day 100,
as appropriate, permitting comparisons of samples collected pre-transplant with samples
3. Related donors of eligible allotransplant recipients (Donor-Subjects)
1. Recipient-Subjects with relapse will have clinical and research evaluations at baseline
and at six, 12 and 24 months post-allotransplant, then yearly. Evaluation after relapse
treatment response and for new protocol options is permitted.
2. Recipient-Subjects in remission will have clinical and research evaluations at baseline
and six, 12 and 24 months post-allotransplant. Evaluation for new protocol options,
e.g., for relapse, is permitted.
3. Pre-Transplant Subjects will have clinical and research evaluations at baseline and at
three months post-allotransplant, thereafter per cohort assignment.
4. Donor-Subjects will undergo a clinical evaluation and cell collection for
Recipient-Subject therapy and research. Return evaluation for additional clinical
product collection is permitted.
5. Accrual Ceiling: 500 consented subjects (350 Recipient-Subjects and 150 Donor-Subjects)
over 5 years, averaging 70 Recipient-Subjects and 30 Donor-Subjects enrolled per year.
Time Perspective: Prospective
Nancy M Hardy, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|