AML Clinical Trial
Official title:
Photochemotherapy of Acute Graft-versus-host Disease (aGVHD) of the Skin - is Graft-versus-leukemia Preserved in Patients Transplanted for Acute Leukemia?
Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the
anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not
known whether the tumor-immunity is affected by photochemotherapy (psoralene
photosensitization and ultraviolet light radiation) administered to attenuate graft-versus
host disease (GVHD).
The present study aim to investigate what happens to the GVL after photochemotherapy of
aGVHD in a predominantly retrospective setting with 10-years follow-up after HSCT
This is a 10-year follow-up of patients with Acute-myeloid-leukemia (AML) or
acute-lymphatic-leukemia (ALL). AML is diagnosed by the French-American-British criteria
(FAB-criteria) and ALL is separated into chief forms by immunohistological methods. All
patients underwent myeloablative Hematopoietic Stem Cell Transplantation (HSCT) between 1985
and 2005 at the center for allogeneic stem cell transplantation (CAST) at Karolinska
University Hospital. All patient receive GVHD-prophylaxis.
The risk for relapse after HSCT is graded into low-risk if the disease is in first complete
remission before HSCT, all other disease states are classified as high-risk.
Eligible patients received photochemotherapy (Ultraviolet radiation type A on skin
photosensitized by oral 8-methoxypsoralen) for acute graft-versus-host disease (GVHD within
100-days after HSCT). Photochemotherapy may be given as primary or later aGVHD therapy.
Patients with aGVHD after booster doses of stem-cells or donor-lymphocyte-infusions are not
included.
Additional treatment are registered where present. Methotrexate is not considered as an
additional GVHD treatment as intravenous methotrexate a part of the governing GVHD
prophylaxis and as the effects of methotrexate as a secondary aGVHD treatment is weak.
At the start, the end, at maximum and up until two weeks after end of PUVA-therapy the GVHD
is diagnosed in accordance with Glucksberg and indexed by CIBMTR.
Relapse is diagnosed when leukemic cells is present extra medullary or with a bone marrow
biopsy with ≥ 30% blasts. Early relapse is diagnosed when the medulla contain 5 - 30% blasts
The primary outcome is GVL i.e. abscence of relapse in malignant disease or minimal residual
disease (MRD) i.e. threatening relapse in malignant disease demanding donor lymphocyte
infusion (DLI).
Primary predictor: Time-to-treatment by photochemotherapy at day 0 - 7 vs. start at day 8 ≤
of aGVHD.
Continuous secondary predictor: Time-to-treatment by photochemotherapy as a continuous
variable (days after start of aGVHD).
Binary secondary predictors: Risk (Low/High), Sibling donor-recipient (Yes/No), Mismatched
related (Yes/No), Unrelated donor (Yes/No), (Male recipients of female grafts (Yes/No),
T-cell depletion or Anti-Thymocyte Globulin (Yes/No).
Categorical secondary predictors: AGVHD organ disease stage and disease grade; Skin (+, ++,
+++, ++++), Liver (+, ++, +++, ++++), Gastro-intestinal (+, ++, +++, ++++), Center for
International Blood and Marrow Transplant Research CIBMTR index (A, B, C, D) respectively.
Statistical analysis:
Cox proportional Hazards ratio is used to conduct a univariate data analysis of all adequate
variables in patient characteristics and disease towards the primary outcome. In the
analysis, death, DLI or retransplantation due to graft-failure was treated as a competing
event. The primary predictor (binary) and all binary or categorical covariates identified
from the patient and disease characteristics are to be included in a multivariate forward
regression analysis, controlled for with backward regression based on the log-likelihood
method. P=0.05 is considered as significant and p=0.10 as a trend. StatSoft, Inc. (2013).
STATISTICA (data analysis software system), version 12. www.statsoft.com. are used for
statistical computation.
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Observational Model: Cohort, Time Perspective: Retrospective
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