Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003402
Status:
COMPLETED
Last Update Posted:
2019-10-17
First Post:
1999-11-01
Brief Title:
Peripheral Stem Cell Transplantation Plus Combination Chemotherapy in Treating Patients With Low-Grade Non-Hodgkins Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Autologous Transplantation With and High Dose BCNU and Melphalan Followed by Consolidation With DCEP Plus TaxolCisplatin in Patients With Poor Prognosis Low Grade Non-Hodgkins Lymphoma and Chronic Lymphocyte Leukemia Who Have Received or 12 Months of Standard Therapy
Status:
COMPLETED
Status Verified Date:
2019-10
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkins lymphoma or chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy in treating patients who have low-grade non-Hodgkins lymphoma or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES I Evaluate the complete and partial response rates to treatment with peripheral blood stem cell supported high dose carmustine and melphalan followed by consolidation therapy with dexamethasonecyclophosphamideetoposidecisplatin DCEP and dexamethasone paclitaxel and cisplatin in patients with poor prognosis low grade non-Hodgkins lymphoma or chronic lymphocytic leukemia and no greater than 12 months of prior standard therapy II Evaluate the incidence of early deaths less than 60 days posttransplant in comparison with historical experience in this patient population III Evaluate the toxicity of posttransplantation chemotherapy with DCEP and dexamethasone paclitaxel and cisplatin in these patients
OUTLINE Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1 followed by peripheral blood stem cell infusion on day 0 At 3 months and 9 months after completion of autologous transplantation patients receive cyclophosphamide etoposide and cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4 days At 6 and 12 months after completion of autologous transplantation patients receive dexamethasone orally every day for 4 days paclitaxel continuous IV infusion over 6 hours on day 2 and cisplatin continuous IV infusion over 24 hours on day 3
PROJECTED ACCRUAL There will be 12-35 patients accrued into this study over 1-25 years
OUTLINE Patients receive carmustine IV over 2 hours on day -2 and melphalan IV on day -1 followed by peripheral blood stem cell infusion on day 0 At 3 months and 9 months after completion of autologous transplantation patients receive cyclophosphamide etoposide and cisplatin by continuous IV infusion for 4 days plus dexamethasone orally every day for 4 days At 6 and 12 months after completion of autologous transplantation patients receive dexamethasone orally every day for 4 days paclitaxel continuous IV infusion over 6 hours on day 2 and cisplatin continuous IV infusion over 24 hours on day 3
PROJECTED ACCRUAL There will be 12-35 patients accrued into this study over 1-25 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 |
|---|---|---|---|
| NCI-V98-1439 | None | None | None |
| MSGCC-9734 | None | None | None |