Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002501
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
1999-11-01
Brief Title:
Cyclophosphamide and Filgrastim in Treating Patients With Stage IV Relapsed or Refractory Low-Grade Follicular Non-Hodgkins Lymphoma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
PHASE II STUDY OF HIGH-DOSE CYCLOPHOSPHAMIDE PLUS RECOMBINANT HUMAN GRANULOCYTE-COLONY STIMULATING FACTOR rhG-CSF IN THE TREATMENT OF FOLLICULAR LOW-GRADE NON-HODGKINS LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2016-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in treating patients with stage IV relapsed or refractory low-grade follicular non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of cyclophosphamide and filgrastim in treating patients with stage IV relapsed or refractory low-grade follicular non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the feasibility of high-dose cyclophosphamide and filgrastim G-CSF in patients with stage IV relapsed or progressive low-grade follicular non-Hodgkins lymphoma II Determine the toxic effects of this regimen in these patients including those with marrow involvement III Determine the rates of complete remission CR and partial remission and time to failure in previously treated and untreated patients IV Determine the effectiveness of this regimen in eradicating bcl-2 rearrangements as determined by polymerase chain reaction PCR in previously untreated patients V Correlate the duration of CR to PCR results in responding patients
OUTLINE Patients are stratified according to prior treatment yes vs no Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim G-CSF subcutaneously beginning on day 3 and continuing until blood counts recover Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease Patients who achieve complete remission CR after completion of course 4 receive 2 additional courses Patients who achieve partial remission PR after completion of course 4 receive 2 additional courses and those who achieve CR after completion of course 6 receive 2 additional courses Patients are followed every 2 months for 6 months every 6 months for 2 years and then annually thereafter
OUTLINE Patients are stratified according to prior treatment yes vs no Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim G-CSF subcutaneously beginning on day 3 and continuing until blood counts recover Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease Patients who achieve complete remission CR after completion of course 4 receive 2 additional courses Patients who achieve partial remission PR after completion of course 4 receive 2 additional courses and those who achieve CR after completion of course 6 receive 2 additional courses Patients are followed every 2 months for 6 months every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| CLB-9150 | None | None | None |
| CDR0000077861 | REGISTRY | NCI Physician Data Query | None |