Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | Any - 70 |
Updated: | 10/14/2017 |
Start Date: | September 2003 |
End Date: | June 2015 |
Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)
The goal of this clinical research study is to see if receiving a transplant of blood stem
cells (cells that can produce blood) or bone marrow from either a related donor (brother,
sister or other relative) or an unrelated voluntary donor will help patients with advanced
cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain
free of disease will also be studied.
cells (cells that can produce blood) or bone marrow from either a related donor (brother,
sister or other relative) or an unrelated voluntary donor will help patients with advanced
cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain
free of disease will also be studied.
You will receive the chemotherapy drug fludarabine for 5 days (Days 1 to 5). The drug
melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte
globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone
marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can
be a brother, sister or another family member or a compatible unrelated donor. The drugs and
the stem cells will be given through a catheter (a small tube) placed under the collarbone.
You may receive your treatment on an inpatient or outpatient basis. If treated on an
inpatient basis, you will stay in the hospital during treatment and recovery, which can take
4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or
bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF
(Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an
injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to
receive donor blood cells (lymphocytes) infused through the catheter. This may cause
graft-versus-host disease and may help shrink the cancer. If the cancer grows and
graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection".
Sometimes the donor cells attack the body, a reaction called graft-versus-host disease
(GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions
from occurring. These drugs are given through a vein or by mouth before and/or after the
transplant.
You must stay in the Houston area for at least 100 days after the transplant. After 100 days,
you must return to Houston every 3 months for 2 years for tests and checkups, then once a
year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s),
you will receive no further treatment.
This is an investigational study. The drugs used in this study are approved by the FDA and
are commercially available. As many as 35 patients will take part in the study. All will be
enrolled at MD Anderson.
melphalan will be given on Days 4 and 5. You may also receive the drug anti-thymocyte
globulin (ATG) on Days 4, 5, 6. This will be followed by infusion of blood stem cells or bone
marrow from a donor on Day 7. A separate consent will be provided to the donor. The donor can
be a brother, sister or another family member or a compatible unrelated donor. The drugs and
the stem cells will be given through a catheter (a small tube) placed under the collarbone.
You may receive your treatment on an inpatient or outpatient basis. If treated on an
inpatient basis, you will stay in the hospital during treatment and recovery, which can take
4 to 5 weeks even if there are no complications.
The chemotherapy and the ATG are given to help the body accept the transplanted stem cells or
bone marrow. You will receive antibiotics to fight infection and a medicine called G-CSF
(Neupogen®) to help blood counts rise back to healthier levels. G-CSF is given as an
injection under the skin. You will also need blood and platelet transfusions.
You will be given standard drugs to help decrease the risk of side effects. You may ask the
study staff for information about how the drugs are given and their risks.
If the cancer grows and graft-versus-host disease is not present, you may be eligible to
receive donor blood cells (lymphocytes) infused through the catheter. This may cause
graft-versus-host disease and may help shrink the cancer. If the cancer grows and
graft-versus-host disease is already present, then donor lymphocytes are not given.
Sometimes, the body rejects the donor cells; this reaction is called "graft rejection".
Sometimes the donor cells attack the body, a reaction called graft-versus-host disease
(GvHD). The drugs tacrolimus and methotrexate will be given to help prevent these reactions
from occurring. These drugs are given through a vein or by mouth before and/or after the
transplant.
You must stay in the Houston area for at least 100 days after the transplant. After 100 days,
you must return to Houston every 3 months for 2 years for tests and checkups, then once a
year for at least 3 years. If there is no sign of lymphoma growth at the follow up visit(s),
you will receive no further treatment.
This is an investigational study. The drugs used in this study are approved by the FDA and
are commercially available. As many as 35 patients will take part in the study. All will be
enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with pathologically proven CTCL, disease stage IIB to IVB, patients must be
in at least a PR (skin and lymph nodes) after receiving other non-allogeneic
transplant therapy, age = 70 years, Zubrod performance status 0 or 1, left
ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist,
DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine
= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no
previous history of allogeneic transplantation.
2. Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch)
or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen
mismatch).
Exclusion Criteria:
1) Patients cannot have active CNS disease.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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