Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506129
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2007-07-20
Brief Title:
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma CTCL
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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 visits 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
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 andor 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 visits 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01547 | REGISTRY | NCI CTRP | None |