Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058825
Status:
TERMINATED
Last Update Posted:
2016-11-06
First Post:
2003-04-11
Brief Title:
Stem Cell Transplant for Hematologic Diseases
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase III Study of Allogeneic Stem Cell Transplantation for Patients With Hematologic Diseases Using Haploidentical Family Donors and Sub-Myeloablative Conditioning With Campath 1H
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual due to practice changes meant study would take too long to finish
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIMSUM
Brief Summary:
Patients are being asked to participate in this study because they have a cancer in their blood Fanconis Anemia or have been unsuccessfully treated for bone marrow failure such as Aplastic Anemia or Paroxysmal Nocturnal Hemoglobinuria Any of these conditions could benefit from an allogeneic stem cell transplant using a donor that is related to the patient
Stem cells are created in the bone marrow They grow into different types of blood cells that the patient needs including red blood cells white blood cells and platelets In a transplant the patients own stem cells are killed and then replaced by stem cells from the donor
Usually patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant However because of the patients condition they have a high risk of experiencing life-threatening treatment-related side-effects Recently some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant
This research study adds CAMPATH 1H to a low-dose chemotherapy regimen followed by an allogeneic stem cell transplantation We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease We also want to see whether there are fewer life-threatening side-effects from the treatment CAMPATH 1H is a drug that is still being studied CAMPATH 1H stays active in the body for a long time after patients receive it which means it may work longer at preventing graft-versus-host-disease GvHD symptoms
Stem cells are created in the bone marrow They grow into different types of blood cells that the patient needs including red blood cells white blood cells and platelets In a transplant the patients own stem cells are killed and then replaced by stem cells from the donor
Usually patients are given very strong doses of chemotherapy prior to receiving a stem cell transplant However because of the patients condition they have a high risk of experiencing life-threatening treatment-related side-effects Recently some doctors have begun to use chemotherapy that does not cause as many side-effects before patients receive a transplant
This research study adds CAMPATH 1H to a low-dose chemotherapy regimen followed by an allogeneic stem cell transplantation We want to see whether adding CAMPATH 1H to the transplant medications helps in treating the disease We also want to see whether there are fewer life-threatening side-effects from the treatment CAMPATH 1H is a drug that is still being studied CAMPATH 1H stays active in the body for a long time after patients receive it which means it may work longer at preventing graft-versus-host-disease GvHD symptoms
Detailed Description:
Before treatment begins stem cells will be collected from the donors blood or bone marrow The stem cells will be collected and frozen before we start to give the patient chemotherapy
After admission to the hospital patients will receive total body irradiation very strong x-rays that kill cells in the bone marrow Fludarabine and Campath 1H prior to the stem cell transplant infusion of the donors stem cells
Starting 7 days after the transplant the patient will be given G-CSF by subcutaneous injection until a blood test shows that numbers of granulocytes a type of white blood cell in the blood are more than 1000uL This is to help increase blood cell counts
After transplantation the patient will undergo several evaluations at different times These are standard evaluations and tests performed for any patient who has received a stem cell transplant as part of routine clinical monitoring
We will also be looking at the patients immune function how the body protects itself to prevent and fight infections and diseases To do this blood tests will be performed at regular intervals every 3 to 6 months for 2 years
Depending on how well the donor stem cells work in the body after the transplant the patient may receive one or more Donor Leukocyte Infusions DLI This is when leukocytes a type of white blood cell collected from the same donor that provided the stem cells are given to the patient through a central line into a vein
After admission to the hospital patients will receive total body irradiation very strong x-rays that kill cells in the bone marrow Fludarabine and Campath 1H prior to the stem cell transplant infusion of the donors stem cells
Starting 7 days after the transplant the patient will be given G-CSF by subcutaneous injection until a blood test shows that numbers of granulocytes a type of white blood cell in the blood are more than 1000uL This is to help increase blood cell counts
After transplantation the patient will undergo several evaluations at different times These are standard evaluations and tests performed for any patient who has received a stem cell transplant as part of routine clinical monitoring
We will also be looking at the patients immune function how the body protects itself to prevent and fight infections and diseases To do this blood tests will be performed at regular intervals every 3 to 6 months for 2 years
Depending on how well the donor stem cells work in the body after the transplant the patient may receive one or more Donor Leukocyte Infusions DLI This is when leukocytes a type of white blood cell collected from the same donor that provided the stem cells are given to the patient through a central line into a vein
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