Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001337
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
1999-11-03
Brief Title:
Dose-Adjusted EPOCH Chemotherapy and Rituximab CD20 in Previously Untreated Aggressive Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dose-Adjusted EPOCH Chemotherapy and Rituximab CD20 in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-06-13
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:
5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation EPOCH Etoposide VP-16 NSC-141540 Prednisone PRED NSC-10023 Vincristine VCR NSC-67574 Cyclophosphamide CTX NSC-26271 Doxorubicin DOX NSC-123127 with Granulocyte Colony-Stimulating Factor Amgen G-CSF NSC-614629
Detailed Description:
Background
The treatment of the intermediate and aggressive non-Hodgkins lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population and about 23 of the complete responders appear to have prolonged disease-free survival
The present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support
Objectives
Primary
Assess complete response CR and progression-free survival PFS of dose-adjusted EPOCH-Rituximab DA-EPOCH-R with G-CSF in agressive B-cell lymphomas
Eligibility
Non-Hodgkins lymphomas in the following categories mediastinal gray zone lymphoma MGZL and primary mediastinal B cell lymphoma PMBL
Patients greater than or equal to 12 years old
Any Stage for PMBL and MGZL
No prior systemic chemotherapy
HIV negative
Design
This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment
Patients receive prednisone orally for 5 days a 96 hour infusion of vincristine doxorubicin and etoposide and a bolus of cyclophosphamide on day 5
Cycles are repeated every 21 days for a total of 6-8 cycles
Patients with CD20 expressing tumors ie mature B-cell lymphomas will also receive rituximab the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle
A total of 348 patients will be enrolled on this protocol
The treatment of the intermediate and aggressive non-Hodgkins lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population and about 23 of the complete responders appear to have prolonged disease-free survival
The present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support
Objectives
Primary
Assess complete response CR and progression-free survival PFS of dose-adjusted EPOCH-Rituximab DA-EPOCH-R with G-CSF in agressive B-cell lymphomas
Eligibility
Non-Hodgkins lymphomas in the following categories mediastinal gray zone lymphoma MGZL and primary mediastinal B cell lymphoma PMBL
Patients greater than or equal to 12 years old
Any Stage for PMBL and MGZL
No prior systemic chemotherapy
HIV negative
Design
This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment
Patients receive prednisone orally for 5 days a 96 hour infusion of vincristine doxorubicin and etoposide and a bolus of cyclophosphamide on day 5
Cycles are repeated every 21 days for a total of 6-8 cycles
Patients with CD20 expressing tumors ie mature B-cell lymphomas will also receive rituximab the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle
A total of 348 patients will be enrolled on this protocol
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 |
|---|---|---|---|
| 93-C-0133 | None | None | None |