A Study of Allogeneic Blood Stem Cell Transplantation With Purine Analog-Based Conditioning For Patients With Advanced Hodgkin's Disease
All patients in this study must have a plastic tube (catheter) inserted into a vein under
the collarbone. Drugs and stem cells will be given through this tube.
Fludarabine will be given through the catheter once a day for four days. Patients will also
receive melphalan for two days through the catheter. Patients receiving a transplant from a
matched unrelated donor (i.e. not a blood relative) or a mismatched related donor (i.e. a
blood relative, but not a full match) will also receive antithymocyte globulin (ATG) once a
day for three days. ATG can help preventing graft-versus-host disease. All patients are
expected to need blood transfusions as part of this treatment.
Beginning two days before the transplant, tacrolimus will be given through the catheter. It
will be given 24 hours a day until the patient can swallow. The patient will then swallow
one or more tacrolimus pills a day for about 6 months.
On the transplant day ("day 0"), the stem cells or bone marrow obtained from the donor will
be infused through the catheter ("transplant"). Drugs will be given to reduce the chance of
allergic reactions. Starting on day 7 after the transplant, filgrastim will be given
through a needle to increase the growth of white blood cells. Methotrexate will be given by
IV on days 1,3,6, 11 after the transplant. The patient may require blood transfusions for
the following 2-4 weeks and sometimes longer.
Patients with progressive ("growing") Hodgkin's disease after the transplant will initially
be taken off their immunosuppressive medications (tacrolimus, corticosteroids). If there is
no response to this maneuver, they will be considered for infusion of additional cells from
their donors, with or without preceding chemotherapy Both these maneuvers may produce a
response ("shrinkage") of the tumor. Patients with persistent but stable (not "growing")
disease may also be treated in a similar fashion. Potential side effects of the infusion of
additional cells include graft-versus-host disease and /or a generalized drop in the blood
counts. Both of these conditions can be serious or life-threatening.
Blood, urine, bone marrow and x-ray examinations will be performed as necessary to monitor
the results of bone marrow transplantation. Patients may require blood and platelet
transfusions. Blood tests will be done daily while hospitalized and several times a week
until the blood counts recover. Bone marrow aspiration and biopsies will be performed prior
to the transplant, when the donated cells show signs of engraftment, and at other times
during the next 1 to 3 years to evaluate the growth of the transplant marrow, to evaluate
possible recurrence of malignancy and recovery of immunity.
This is an investigational study. Up to 50 patients will be treated on this study. If the
initial results are discouraging, the study may be stopped after a minimum of four patients
have been enrolled.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Paolo Anderlini, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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