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Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)

Phase 2
70 Years
Open (Enrolling)
Lymphoma, Bone Marrow Transplantation

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Trial Information

Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)

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

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 ventricular ejection fraction >/= 50% or approved for transplant by a cardiologist,
DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum
creatinine 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

Exclusion Criteria:

1) Patients cannot have active CNS disease.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient's Response

Outcome Time Frame:

Baseline and second assessment at least 4 weeks later

Safety Issue:


Principal Investigator

Chitra M. Hosing, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • Bone Marrow Transplantation
  • Cutaneous T-Cell Lymphoma
  • CTCL
  • Allogeneic Transplantation
  • Lymphoma
  • Allogeneic peripheral blood progenitor cell
  • PBPC
  • Bone Marrow transplantation
  • Stem Cell Transplant
  • SCT
  • Fludarabine
  • Fludarabine Phosphate
  • Fludara
  • Melphalan
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous



UT MD Anderson Cancer Center Houston, Texas  77030