Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455897
Status:
TERMINATED
Last Update Posted:
2018-01-18
First Post:
2007-04-02
Brief Title:
CHOP-Rituximab Augmented With GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkins Lymphoma
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase II Trial of CHOP-Rituximab Augmented With Granulocyte-Macrophage Colony Stimulating Factor GM-CSF in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual was too slow Trial terminated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this study is to determine the effects good and bad of Granulocyte-macrophage colony stimulating factor GM-CSF in combination with Cytoxan Adriamycin Vincristine Prednisone Rituximab CHOP-R on diffuse Large B cell Non-Hodgkins lymphoma DLBCL The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab CHOP-R The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide doxorubicin and vincristine prednisone and rituximab GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma
Detailed Description:
Study treatment is divided into 21-day time periods called cycles Almost all participants will be treated as outpatients unless they have an existing medical problem that requires them to be treated as in inpatient
The drugs used in this study treatment are standard of care for this type of lymphoma and participants could receive these even if they are not taking part in the study
Participants will start receiving GM-CSF 11 days before Day 1 of Cycle 1 for 10 days They will receive the first dose of GM-CSF at the clinic At least 1 12 days after the last GM-CSF injection Day 1 they will receive chemotherapy CHOP-R Eleven days before they start the next cycle Days 11-20 they will again start to receive GM-CSF injections for 10 days
Participants will receive up to 6 cycles of study treatment if their disease is responding and they are tolerating the study treatment
Additional medications may be given to prevent lung infection return of brain and nervous system disease and tumor lysis syndrome
Before beginning GM-CSF during each cycle of treatment blood will be drawn to monitor the participants health and to check for side effects
On Day 1 of each cycle a physical examination and blood tests will be performed On Day 7 and Day 14 of each cycle routine blood tests will also be done
After Cycle 2 and 4 CT scans of the neck chest abdomen and pelvis will be performed to check the status of the participants disease
After 6 cycles of study treatment the participant will return to the clinic for an End of Treatment Visit At this visit a physical exam routine blood tests and CT scan of neck chest abdomen and pelvis will be performed
The participant will be asked to return to the clinic every 3 months for the first year after study treatment and every 6 months up to 2 years after study treatment for the procedures outline in the End of Treatment Visit
The drugs used in this study treatment are standard of care for this type of lymphoma and participants could receive these even if they are not taking part in the study
Participants will start receiving GM-CSF 11 days before Day 1 of Cycle 1 for 10 days They will receive the first dose of GM-CSF at the clinic At least 1 12 days after the last GM-CSF injection Day 1 they will receive chemotherapy CHOP-R Eleven days before they start the next cycle Days 11-20 they will again start to receive GM-CSF injections for 10 days
Participants will receive up to 6 cycles of study treatment if their disease is responding and they are tolerating the study treatment
Additional medications may be given to prevent lung infection return of brain and nervous system disease and tumor lysis syndrome
Before beginning GM-CSF during each cycle of treatment blood will be drawn to monitor the participants health and to check for side effects
On Day 1 of each cycle a physical examination and blood tests will be performed On Day 7 and Day 14 of each cycle routine blood tests will also be done
After Cycle 2 and 4 CT scans of the neck chest abdomen and pelvis will be performed to check the status of the participants disease
After 6 cycles of study treatment the participant will return to the clinic for an End of Treatment Visit At this visit a physical exam routine blood tests and CT scan of neck chest abdomen and pelvis will be performed
The participant will be asked to return to the clinic every 3 months for the first year after study treatment and every 6 months up to 2 years after study treatment for the procedures outline in the End of Treatment Visit
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