Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004231
Status:
COMPLETED
Last Update Posted:
2012-06-06
First Post:
2000-01-28
Brief Title:
Combination Chemotherapy Bone Marrow or Peripheral Stem Cell Transplantation andor Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of Multimodality Therapy in Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2012-05
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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation andor biological therapy in treating patients who have stage III stage IV or recurrent mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation andor biological therapy in treating patients who have stage III stage IV or recurrent mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation andor interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma
Determine the complete response rate in these patients after these treatments
Evaluate the prognostic factors in this patient population
OUTLINE This is a multicenter study
Patients receive induction chemotherapy consisting of cyclophosphamide IV doxorubicin IV and teniposide IV over 2 hours on day 1 oral prednisone on days 1-5 vincristine IV and methotrexate IV over 2 hours on day 21 cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22 and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover Treatment repeats every 42 days for 2 courses Patients achieving complete response or partial response receive an additional course of induction therapy Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation BMT Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 35 days At 24 hours following the last dose of busulfan patients receive cyclophosphamide IV over 2 hours daily for 2 days Patients receive allogeneic bone marrow infusion on day 0
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell PBSC transplantation Patients undergo PBSC mobilization following completion of cyclophosphamide doxorubicin and teniposide portion of induction therapy of course 3 Patients receive cytokines subcutaneously SQ beginning 2 days following chemotherapy and continuing through PBSC collection If insufficient stem cells are collected and there is negative bone marrow involvement patients undergo bone marrow harvest Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim G-CSF SQ beginning on day 0 and continuing until blood counts recover Following blood count recovery patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks Treatment repeats every 8 weeks for 2 courses
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy
Patients are followed at 30 days post transplant every 3 months for 1 year and then at least every 6 months for 2 years
PROJECTED ACCRUAL A total of 15-48 patients will be accrued for this study over 3 years
Determine the toxicities of combination chemotherapy followed by allogeneic or autologous bone marrow transplantation or peripheral blood stem cell transplantation andor interferon and interleukin therapy in patients with refractory or stage III or IV mantle cell lymphoma
Determine the complete response rate in these patients after these treatments
Evaluate the prognostic factors in this patient population
OUTLINE This is a multicenter study
Patients receive induction chemotherapy consisting of cyclophosphamide IV doxorubicin IV and teniposide IV over 2 hours on day 1 oral prednisone on days 1-5 vincristine IV and methotrexate IV over 2 hours on day 21 cytarabine IV over 2 hours every 12 hours for a total of 2 doses on day 22 and oral leucovorin calcium every 6 hours beginning on day 22 and continuing until methotrexate levels recover Treatment repeats every 42 days for 2 courses Patients achieving complete response or partial response receive an additional course of induction therapy Patients achieving maximal response following 2 courses of induction chemotherapy undergo transplantation
Patients under 50 years with an HLA matched donor undergo allogeneic bone marrow transplantation BMT Patients receive busulfan IV every 6 hours for a total of 14 doses beginning on day -8 and continuing for 35 days At 24 hours following the last dose of busulfan patients receive cyclophosphamide IV over 2 hours daily for 2 days Patients receive allogeneic bone marrow infusion on day 0
Patients under 50 years with no HLA matched donor or patients 50-65 years old undergo autologous bone marrow or peripheral blood stem cell PBSC transplantation Patients undergo PBSC mobilization following completion of cyclophosphamide doxorubicin and teniposide portion of induction therapy of course 3 Patients receive cytokines subcutaneously SQ beginning 2 days following chemotherapy and continuing through PBSC collection If insufficient stem cells are collected and there is negative bone marrow involvement patients undergo bone marrow harvest Patients receive a conditioning regimen consisting of busulfan and cyclophosphamide as for allogeneic BMT Patients receive autologous bone marrow or PBSC infusion on day 0 and filgrastim G-CSF SQ beginning on day 0 and continuing until blood counts recover Following blood count recovery patients receive maintenance therapy consisting of interferon alfa SQ and interleukin-2 SQ daily over 5 consecutive days for 4 weeks Treatment repeats every 8 weeks for 2 courses
Patients 65 years or older achieving complete or partial response to induction chemotherapy receive maintenance therapy as for autologous BMT Patients achieving partial response may receive an additional 4th course of induction therapy prior to maintenance therapy
Patients are followed at 30 days post transplant every 3 months for 1 year and then at least every 6 months for 2 years
PROJECTED ACCRUAL A total of 15-48 patients will be accrued for this study over 3 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 |
|---|---|---|---|
| NU-96H3 | None | None | None |
| NCI-G99-1659 | None | None | None |