Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00506129|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : June 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Bone Marrow Transplantation||Drug: Fludarabine Drug: Melphalan Procedure: Allogeneic Transplant Drug: Thymoglobulin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
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.
2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
- Patient's Response [ Time Frame: Baseline and second assessment at least 4 weeks later ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|