Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041665
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2002-07-11
Brief Title:
Recombinant Human Keratinocyte Growth Factor to Reduce Oral Mucositis in Hematologic Malignancy Patients Undergoing Peripheral Blood Stem Cell Transplantation After Radiation and High-dose Chemotherapy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Trial of Recombinant Human Keratinocyte Growth Factor for Reduction of Mucositis in Patients With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy With Autologous PBPC Transplantation
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood stem cell transplantation is frequently used as treatment for patients with cancers of the bone marrow or lymph nodes such as Hodgkins disease non-Hodgkins lymphoma leukemia or multiple myeloma A common side effect of the radiotherapy and high dose chemotherapy is mucositis inflammation of the inside of the mouth and throat resulting in pain and difficulty swallowing Mucositis is often very severe such that patients receive intravenous nutrition and pain medication in the hospital
In this study an investigational recombinant human growth factor called Keratinocyte Growth Factor rHuKGF is being evaluated to determine its protective effect on the mucosal tissue and its ability to reduce the mouth and throat soreness
In this study an investigational recombinant human growth factor called Keratinocyte Growth Factor rHuKGF is being evaluated to determine its protective effect on the mucosal tissue and its ability to reduce the mouth and throat soreness
Detailed Description:
None
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 |
|---|---|---|---|
| FHCRC-161200 | None | None | None |
| NLM Identifier NCT00020813 | None | None | None |
| UCLA-0012064 | None | None | None |
| MSKCC-01065 | None | None | None |