Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
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.
Bone Marrow Transplantation
Procedure: Allogeneic Transplant
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)|
- Patient's Response [ Time Frame: Baseline and second assessment at least 4 weeks later ] [ Designated as safety issue: No ]
- Median Survival Length [ Time Frame: Baseline to disease progression (assess at 100 days, every 3 months for 2 years, then once a year for at least 3 years) ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Fludarabine + Melphalan with PBPC
Fludarabine 25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant. Melphalan 70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant. Allogeneic transplant given by vein after completion of Fludarabine and Melphalan. Thymoglobulin 2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
25 mg/m^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.
Other Names:Drug: Melphalan
70 mg/m^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.Procedure: Allogeneic Transplant
Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.
Other Names:Drug: Thymoglobulin
2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506129
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Chitra M. Hosing, MD||M.D. Anderson Cancer Center|