MD Anderson OncoLog, Volume 45, Number 7/8, July/August 2000 Page: 3
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1992 to develop a nonablative
preparative regimen, also known
as a "minitransplant," which allows
for a graft-versus-malignancy effect
without the toxic effects of tradi-
tional mveloablative regimens. More
recently, Paolo Anderlini, M.D., an
assistant professor in the Department
of Blood and Marrow Transplanta-
tion, has extended this approach to
Hodgkin's disease, and Assistant
Professor Naoto T. Ueno, M.D.,Ph.D.,
of the same department, has studied
this strategy in breast cancer and
renal cell carcinoma.
The preparative regimen had
to meet three criteria: it had to
be immunosuppressive to prevent
rejection, it had to be able to controlthe patient's cancer, and it had to be
minimally toxic. Radiation therapy
was not included in the regimen, and
the chemotherapy chosen was based
on fludarabine, a purine analogue
that meets all three criteria.
The fludarabine-based regimens
can be given at low doses in the
outpatient setting and are immuno-
suppressive enough that the trans-
plants will engraft and demonstrate
graft-versus-malignancy effects.
GVHD has generally been milder
and more easily controlled with the
fludarabine-based regimens than
with traditional high-dose ablative
therapy, according to Dr. Champlin.
Minitransplants are typically per-
formed between human leukocyteantigen-identical siblings because as
genetic disparity increases between a
donor and a recipient, so must the
intensity of the preparative regimen.
With the new regimens, allogeneic
transplantation can now be per-
formed in patients who are up to
75 years old and who have such
comorbid conditions as hepatitis
and cardiac or lung abnormalities.
"Indolent lymphoma is an area
where this treatment has been
showing very promising results,"
said Dr. Khouri. Thirteen patients
with low-grade lymphoma have
been treated at M. D. Anderson with
combination therapy that includes
nonablative stem cell transplantation.
(Continued on page 4)PROTOCOLS
tion standard-dose chemotherapy or, for
bone disease, stable disease with clinical
improvement is required. Donors must be
HLA-compatible relatives; patients whose
disease relapsed after autologous
transplantation may use an unrelated,
HLA-matched donor.
" A pilot study to assess the safety and
efficacy of nonmyeloablative chemo-
therapy and allogeneic stem cell trans-
plantation in patients with severe and
refractory autoimmune disease (DMPO0-
085). Physician: Samer Bibawi, M.D.
This study is designed for patients
65 years old or younger with histologi-
cally confirmed autoimmune disease.
Participants must not have symptomatic
cardiac or pulmonary disease, active
infectious hepatitis, or HIV. Peripheral
blood stem cell donors must have no
clinical evidence of autoimmune disease.
Follow-up visits will range from daily
to once weekly up to 100 days after
transplantation, monthly for the follow-
ing six months, and every six to 12
months thereafter.
" A phase Il/Ill, multicenter, open-label,
randomized clinical trial evaluating ABX-
CBL when compared to ATG as second-line therapy in patients with steroid-
resistant acute graft-versus-host disease
(DM00-029). Physician: Daniel Couriel,
M.D.
To be eligible, recipients of a single
allogeneic stem cell transplant who have
acute GVHD must not have received a
subsequent infusion of donor cells or
any immunosuppressant therapy
besides steroids. Participants must
exhibit at least one of the following
symptoms: skin rash involving at least
25% of the body; total bilirubin count >
3.5 mg/dL; diarrhea> 500 mL/day;
nausea and vomiting; epigastric pain;
or upper gastrointestinal disease.
" Megadose T cell-depleted HLA-noniden-
tical blood progenitor cell transplanta-
tion for patients with hematological
malignancies or bone marrow failure
(DM96-122). Physician: James L.
Gajewski, M.D.
This study is for patients with high-
risk hematological malignancies, stage
IV low-grade lymphoma, chronic
lymphocytic leukemia that has not
responded to two treatment regimens,
or severe aplastic anemia that has not
responded to prior immunomodulatory
therapy. Participants must have a relateddonor and be recovered from any toxic
effects of prior therapy.
" Phase I/Il evaluation of safety, pharmaco-
kinetics, and activity of basiliximab
(Simulect) plus corticosteroids as initial
treatment of cutaneous acute graft-
versus-host disease in patients undergo-
ing allogeneic bone marrow or peripheral
blood stem cell transplantation (ID99-
399). Physician: Thomas Martin, M.D.
Patients who have received an
allogeneic stem cell transplant and
who have cutaneous grade 2 or 3
acute GVHD are eligible to participate.
Treatment with Simulect, daclizumab
(Zenapax), ATG, OKT3, photopheresis,
any experimental anti-T cell-directed
monoclonal antibody therapy, or any
investigational agent within 30 days of
study entry is a basis for exclusion.
Other exclusion criteria include a history
of steroid-refractory acute GVHD and
an inability to tolerate steroids. "
FOR MORE INFORMATION about these clinical
trials, physicians orpatients may call
the M. D. A nderson Information Line.
Those within the United States should
call (800) 392-1611.MD Anderson OncoLog / 3
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University of Texas M.D. Anderson Cancer Center. MD Anderson OncoLog, Volume 45, Number 7/8, July/August 2000, periodical, July 2000; Houston, Texas. (https://texashistory.unt.edu/ark:/67531/metapth903446/m1/3/?q=houston: accessed June 26, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.