Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003910
Status:
TERMINATED
Last Update Posted:
2023-07-05
First Post:
1999-11-01
Brief Title:
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of Initial Treatment With Methotrexate in Large Granular Lymphocytic LGL Leukemia
Status:
TERMINATED
Status Verified Date:
2023-06
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 methotrexate with or without cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or anemia
PURPOSE Phase II trial to study the effectiveness of methotrexate with or without cyclophosphamide in treating patients who have lymphocytic leukemia with neutropenia or anemia
Detailed Description:
LGL leukemia is characterized by clonal expansion of cytotoxic T cells Prominent clinical features include neutropenia anemia and rheumatoid arthritis The terminal effector memory phenotype CD3CD8CD57CD45RACD62L- of leukemic LGL suggest a pivotal chronic antigen driven immune response LGL survival is then promoted by PDGF and IL-15 resulting in global dysregulation of apoptosis and resistance to normal pathways of activation-induced death These pathogenic features explain why treatment of LGL leukemia is based on immunosuppression therapy However no standard therapy has been established due to the absence of large prospective trials
Oral low dose MTX has been shown to be efficacious in the treatment of neutropenia However response to MTX is slow requiring several months for the neutrophil count to increase above 500mm3 Also complete clinical remission may not be achieved until after one year of MTX therapy Oral Cy has been the primary drug used for the treatment of severe transfusion-dependent anemia Beneficial clinical effects are seen despite this treatment having no apparent effect on the abnormal LGL clone Normal hematocrits are maintained after cessation of Cy and these results contrast the effects seen with MTX in which clinical remissions are often associated with the disappearance of the clone
This phase II trial undertaken by the Eastern Cooperative Group ECOG was initiated to investigate the mechanism of treatment response in patients with LGL leukemia who need treatment for anemia or neutropenia
Oral low dose MTX has been shown to be efficacious in the treatment of neutropenia However response to MTX is slow requiring several months for the neutrophil count to increase above 500mm3 Also complete clinical remission may not be achieved until after one year of MTX therapy Oral Cy has been the primary drug used for the treatment of severe transfusion-dependent anemia Beneficial clinical effects are seen despite this treatment having no apparent effect on the abnormal LGL clone Normal hematocrits are maintained after cessation of Cy and these results contrast the effects seen with MTX in which clinical remissions are often associated with the disappearance of the clone
This phase II trial undertaken by the Eastern Cooperative Group ECOG was initiated to investigate the mechanism of treatment response in patients with LGL leukemia who need treatment for anemia or neutropenia
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 |
|---|---|---|---|
| E5998 | OTHER | ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |