Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003353
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
1999-11-01
Brief Title:
High-Dose Melphalan Plus Peripheral Stem Cell Transplantation in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of High-Dose Melphalan With Hematopoietic Stem Cell Reconstitution for Patients With Primary Systemic Amyloidosis
Status:
COMPLETED
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 High-dose chemotherapy may destroy the amyloid-producing cells in bone marrow Peripheral stem cell transplantation
PURPOSE Phase II trial to study the effectiveness of high dose melphalan plus peripheral stem cell transplantation in treating patients who have primary systemic amyloidosis
PURPOSE Phase II trial to study the effectiveness of high dose melphalan plus peripheral stem cell transplantation in treating patients who have primary systemic amyloidosis
Detailed Description:
OBJECTIVES I Assess the response rate and overall survival of patients with biopsy proven primary amyloidosis following treatment with myeloablative chemotherapy and hematopoietic stem cell reconstitution II Evaluate the toxicity of high dose melphalan in this patient population
OUTLINE Patients receive filgrastim G-CSF subcutaneously daily beginning on day 1 of the peripheral blood stem cell PBSC collection period and continuing until PBSC collection is completed PBSC are collected beginning on day 5 of the collection period and continuing until the final target cell count is reached or for up to a maximum of 7 collections If sufficient PBSCs are not harvested within a maximum of 7 collections the patient is removed from the study Within 30 days of PBSC collection patients receive melphalan IV on day -1 of the infusion period and PBSC infusion on day 0 The infusion period continues until day 30 Patients receive G-CSF subcutaneously daily starting on day 1 and continuing until blood counts recover Patients are followed every 3 months for 2 years every 3 months for 3 additional years and yearly thereafter
PROJECTED ACCRUAL A maximum of 33 patients will be accrued for this study over 2 years
OUTLINE Patients receive filgrastim G-CSF subcutaneously daily beginning on day 1 of the peripheral blood stem cell PBSC collection period and continuing until PBSC collection is completed PBSC are collected beginning on day 5 of the collection period and continuing until the final target cell count is reached or for up to a maximum of 7 collections If sufficient PBSCs are not harvested within a maximum of 7 collections the patient is removed from the study Within 30 days of PBSC collection patients receive melphalan IV on day -1 of the infusion period and PBSC infusion on day 0 The infusion period continues until day 30 Patients receive G-CSF subcutaneously daily starting on day 1 and continuing until blood counts recover Patients are followed every 3 months for 2 years every 3 months for 3 additional years and yearly thereafter
PROJECTED ACCRUAL A maximum of 33 patients will be accrued for this study over 2 years
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 |
|---|---|---|---|
| E-4A97 | None | None | None |