Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00057005
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2003-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
Phase I Study of Anti-Human CD45 Monoclonal Antibodies in Patients With Advanced Leukemia Prior to Allogeneic Stem Cell Transplantation (ADVL)
Status:
COMPLETED
Status Verified Date:
2020-01
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:
ADVL
Brief Summary:
Participants in this study have a hematologic malignancy which is a disorder in the bone marrow that affects the body's ability to create blood. Participants might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor). The participants donor is a family member. Stem cells are cells in the bone marrow and blood that can form a whole new blood system.
Detailed Description:
Patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. To try and improve on the results of transplants that use high dose chemotherapy alone, we are adding an agent called anti-CD45 to the treatment prior to the stem cell transplant. Anti-CD45 is an antibody that specifically finds and destroys leukemia cells.
Patients will receive the anti-CD45 with high dose chemotherapy (including Ara-C and Cyclophosphamide) and radiotherapy. Patients will also receive Mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. High dose radiotherapy is also known as Total Body Irradiation or TBI.
Patients will receive the anti-CD45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. We expect participation in this study will last 2 years.
A summary of the treatment follows:
* Day - 7: Ara-C, Cyclophosphamide, Mesna
* Day - 6: Ara-C, Cyclophosphamide, Mesna
* Day - 5: Ara-C, Anti-CD45
* Day - 4: Anti-CD45, TBI
* Day - 3: Anti-CD45, TBI
* Day - 2: Anti-CD45, TBI
* Day - 1: TBI
* Day 0: Stem Cell Infusion (transplant)
Patients will receive the anti-CD45 with high dose chemotherapy (including Ara-C and Cyclophosphamide) and radiotherapy. Patients will also receive Mesna which is a drug that helps prevent bladder damage which can be caused by the cyclophosphamide. High dose radiotherapy is also known as Total Body Irradiation or TBI.
Patients will receive the anti-CD45, high dose chemotherapy, and high dose radiotherapy before the stem cell transplant. We expect participation in this study will last 2 years.
A summary of the treatment follows:
* Day - 7: Ara-C, Cyclophosphamide, Mesna
* Day - 6: Ara-C, Cyclophosphamide, Mesna
* Day - 5: Ara-C, Anti-CD45
* Day - 4: Anti-CD45, TBI
* Day - 3: Anti-CD45, TBI
* Day - 2: Anti-CD45, TBI
* Day - 1: TBI
* Day 0: Stem Cell Infusion (transplant)
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ADVL | None | None | View |