Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000658
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
1999-11-02
Brief Title:
A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkins Lymphoma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2021-10
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:
To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkins lymphoma NHL
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective the outcome of therapy for patients with AIDS-associated NHL has been disappointing Treatment is frequently complicated by the occurrence of multiple opportunistic infections as well as the presence of poor bone marrow reserve making the administration of standard doses of chemotherapy difficult A recent study was completed using a low-dose modification of the standard mBACOD cyclophosphamide doxorubicin vincristine bleomycin dexamethasone methotrexate treatment A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15 It is hoped that the use of sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF will improve bone marrow function and allow for administration of a higher dose of chemotherapy
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective the outcome of therapy for patients with AIDS-associated NHL has been disappointing Treatment is frequently complicated by the occurrence of multiple opportunistic infections as well as the presence of poor bone marrow reserve making the administration of standard doses of chemotherapy difficult A recent study was completed using a low-dose modification of the standard mBACOD cyclophosphamide doxorubicin vincristine bleomycin dexamethasone methotrexate treatment A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15 It is hoped that the use of sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF will improve bone marrow function and allow for administration of a higher dose of chemotherapy
Detailed Description:
HIV-infected patients are at increased risk for developing intermediate and high-grade NHL While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective the outcome of therapy for patients with AIDS-associated NHL has been disappointing Treatment is frequently complicated by the occurrence of multiple opportunistic infections as well as the presence of poor bone marrow reserve making the administration of standard doses of chemotherapy difficult A recent study was completed using a low-dose modification of the standard mBACOD cyclophosphamide doxorubicin vincristine bleomycin dexamethasone methotrexate treatment A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15 It is hoped that the use of sargramostim granulocyte-macrophage colony-stimulating factor GM-CSF will improve bone marrow function and allow for administration of a higher dose of chemotherapy
Patients are randomized to one of two treatment groups Patients are stratified for 1 presence or absence of a prior AIDS diagnosis 2 Karnofsky performance status of 70 or greater and lower than 70 Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time
PER AMENDMENT 53095 This trial was closed to accrual on 11794 on the recommendation of the Data and Safety Monitoring Board DSMB because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment
Patients are randomized to one of two treatment groups Patients are stratified for 1 presence or absence of a prior AIDS diagnosis 2 Karnofsky performance status of 70 or greater and lower than 70 Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time
PER AMENDMENT 53095 This trial was closed to accrual on 11794 on the recommendation of the Data and Safety Monitoring Board DSMB because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment
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 |
|---|---|---|---|
| 11117 | REGISTRY | DAIDS ES Registry Number | None |