Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452023
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2007-03-22
Brief Title:
Pegasys in Patients With Myeloproliferative Diseases
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
PEG IFN-alpha2a Pegasys Therapy in Patients With Chronic Myeloproliferative Diseases Excluding Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2023-05
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 Pegasys IFN-alpha2a can help to control the disease in patients with ET PV AMMMF and Ph-negative CML The safety of this treatment will also be studied
Detailed Description:
IFN-alpha2a has been used for the treatment of a variety of disorders such as hepatitis C IFN-alpha2a is a drug that may affect the way infections and malignant diseases develop
Before treatment starts you will have blood around 2 teaspoons and bone marrow samples collected To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle These samples will be used for tests to confirm the diagnosis of the disease Women who are able to have children must have a negative blood pregnancy test
During treatment you will receive IFN-alpha2a as an injection under the skin once a week You or your caregiver will be taught how to give the injections and you will receive treatment on an outpatient basis
Treatment will continue injections once a week as long as the disease does not get worse
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
During treatment you will have blood around 1 teaspoon collected every other week for 2 months then once every 1 or 2 months for a year then every 3 months You will also have bone marrow samples collected every 3 to 6 months during the first year of treatment After the first year of treatment bone marrow samples will be collected only when your doctor feels they are needed The blood and bone marrow samples will be used for tests to check on the response to therapy
This is an investigational study IFN-alpha2a has been approved by the FDA for the treatment of hepatitis C and is commercially available However the use of IFN-alpha2a in this study is investigational The commercial prepartion of IFN-alpha2aPegasys will be used in this study Up to 280 participants will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will have blood around 2 teaspoons and bone marrow samples collected To collect a bone marrow sample an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle These samples will be used for tests to confirm the diagnosis of the disease Women who are able to have children must have a negative blood pregnancy test
During treatment you will receive IFN-alpha2a as an injection under the skin once a week You or your caregiver will be taught how to give the injections and you will receive treatment on an outpatient basis
Treatment will continue injections once a week as long as the disease does not get worse
If the disease gets worse or you experience any intolerable side effects you will be taken off the study and your doctor will discuss other treatment options with you
During treatment you will have blood around 1 teaspoon collected every other week for 2 months then once every 1 or 2 months for a year then every 3 months You will also have bone marrow samples collected every 3 to 6 months during the first year of treatment After the first year of treatment bone marrow samples will be collected only when your doctor feels they are needed The blood and bone marrow samples will be used for tests to check on the response to therapy
This is an investigational study IFN-alpha2a has been approved by the FDA for the treatment of hepatitis C and is commercially available However the use of IFN-alpha2a in this study is investigational The commercial prepartion of IFN-alpha2aPegasys will be used in this study Up to 280 participants will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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-2012-01474 | REGISTRY | NCI CTRP Clinical Trials Reporting Registry | None |