Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018954
Status:
COMPLETED
Last Update Posted:
2012-02-20
First Post:
2001-07-11
Brief Title:
Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia and Diffuse Non-Hodgkins Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
PILOT MULTINATIONAL PROTOCOLS IN ACUTE LYMPHOBLASTIC LEUKEMIA AND DIFFUSE NON-HODGKINS LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2012-02
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkins lymphoma and acute lymphoblastic leukemia
PURPOSE Phase II trial to study the effectiveness of two treatment regimens for patients in developing countries with diffuse non-Hodgkins lymphoma and acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Provide a standard protocol for specific therapy that is relatively easy to administer and relatively inexpensive but conforms to modern treatment principles and determine whether such therapy can be administered safely and effectively in patients with acute lymphoblastic lymphoma or diffuse non-Hodgkins lymphoma who live in developing countries
Determine the rates of relapse and survival in patients treated with these protocols and relate this data to disease subtype and clinical presentation in order to obtain a database on which to build future stratagems
OUTLINE This is a multicenter study
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841 Patients with mediastinal or localized lymphoblastic lymphoma a single nodal or extranodal site without bone marrow involvement or other types of diffuse non-Hodgkins lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842
Protocol MCP-841
First induction therapy Patients receive daunorubicin DNR IV on days 8 15 and 29 vincristine VCR IV on days 1 8 15 22 and 29 asparaginase ASP intramuscularly IM every other day on days 2-20 oral prednisone PRED on days 1-28 and methotrexate MTX intrathecally IT on days 1 8 15 and 22 Second induction therapy Patients receive oral mercaptopurine MP on days 1-7 and 15-21 cyclophosphamide CTX IV over 30 minutes on days 1 and 15 MTX IT as in first induction therapy and cranial irradiation on days 4-14
Alternative to second induction if a cranial irradiation facility is unavailable Patients receive MP and CTX as in second induction therapy cytarabine ARA-C IV every 12 hours on days 1 2 15 16 29 and 30 and MTX IT on days 8 and 22
Patients with low-risk disease WBC no greater than 10000mm3 age 3 to 6 years no prominent lymphadenopathy less than 3 cm in diameter in each nodal region normal CSF no mediastinal mass no enlargement of liver or spleen and no cranial nerve palsies proceed directly to maintenance therapy All other patients are considered high risk and they repeat first induction therapy and then proceed to consolidation therapy
Consolidation therapy Patients receive MP and CTX as in second induction therapy VCR IV on days 1 and 15 and ARA-C subcutaneously SC every 12 hours on days 1-3 and 15-17
Maintenance therapy Patients receive VCR IV on day 1 DNR IV on day 1 oral PRED on days 1-7 ASP IM on days 1 3 5 and 7 and oral MTX once weekly and oral MP daily on days 15-35 43-63 and 71-91 Maintenance therapy continues for a total of 6 courses
Protocol MCP-842
Patients undergo surgical resection of intra-abdominal masses if feasible Patients with low-risk disease completely resected tumor or a single extra-abdominal site of involvement other than the mediastinum but without lymphoblastic lymphoma are assigned to treatment group 2 All other patients including those with lymphoblastic lymphoma without bone marrow involvement are considered high risk and they are assigned to treatment group 1
Group 1 high risk Patients receive one course of regimen A comprising CTX IV over 15 minutes on days 1-4 VCR IV on days 1 8 and 15 doxorubicin DOX IV on days 1 and 2 ARA-C IV over 3 hours every 12 hours on day 1 ARA-C IT on day 4 and MTX IT on days 8 and 12 Patients then receive one course of regimen B comprising ifosfamide IV over 30 minutes on days 1-5 etoposide IV over 1 hour and MTX IV on days 1-3 VCR IV on day 8 ARA-C IT on days 1 and 4 and MTX IT as in regimen A Patients then receive a second course of regimen A followed by a second course of regimen B
Group 2 low risk Patients receive one course of regimen A followed by one course of regimen B and then a second course of regimen A DOX is withheld during both courses of regimen A IT therapy is withheld during the second course of regimen A
Patients are followed every 2 months for 1 year Protocol MCP-841 or at 1 2 3 4 6 and 8 months Protocol MCP-842 every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 4000 patients will be accrued for this study
Provide a standard protocol for specific therapy that is relatively easy to administer and relatively inexpensive but conforms to modern treatment principles and determine whether such therapy can be administered safely and effectively in patients with acute lymphoblastic lymphoma or diffuse non-Hodgkins lymphoma who live in developing countries
Determine the rates of relapse and survival in patients treated with these protocols and relate this data to disease subtype and clinical presentation in order to obtain a database on which to build future stratagems
OUTLINE This is a multicenter study
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma with any degree of bone marrow involvement are assigned to Protocol MCP-841 Patients with mediastinal or localized lymphoblastic lymphoma a single nodal or extranodal site without bone marrow involvement or other types of diffuse non-Hodgkins lymphoma with or without bone marrow involvement are assigned to Protocol MCP-842
Protocol MCP-841
First induction therapy Patients receive daunorubicin DNR IV on days 8 15 and 29 vincristine VCR IV on days 1 8 15 22 and 29 asparaginase ASP intramuscularly IM every other day on days 2-20 oral prednisone PRED on days 1-28 and methotrexate MTX intrathecally IT on days 1 8 15 and 22 Second induction therapy Patients receive oral mercaptopurine MP on days 1-7 and 15-21 cyclophosphamide CTX IV over 30 minutes on days 1 and 15 MTX IT as in first induction therapy and cranial irradiation on days 4-14
Alternative to second induction if a cranial irradiation facility is unavailable Patients receive MP and CTX as in second induction therapy cytarabine ARA-C IV every 12 hours on days 1 2 15 16 29 and 30 and MTX IT on days 8 and 22
Patients with low-risk disease WBC no greater than 10000mm3 age 3 to 6 years no prominent lymphadenopathy less than 3 cm in diameter in each nodal region normal CSF no mediastinal mass no enlargement of liver or spleen and no cranial nerve palsies proceed directly to maintenance therapy All other patients are considered high risk and they repeat first induction therapy and then proceed to consolidation therapy
Consolidation therapy Patients receive MP and CTX as in second induction therapy VCR IV on days 1 and 15 and ARA-C subcutaneously SC every 12 hours on days 1-3 and 15-17
Maintenance therapy Patients receive VCR IV on day 1 DNR IV on day 1 oral PRED on days 1-7 ASP IM on days 1 3 5 and 7 and oral MTX once weekly and oral MP daily on days 15-35 43-63 and 71-91 Maintenance therapy continues for a total of 6 courses
Protocol MCP-842
Patients undergo surgical resection of intra-abdominal masses if feasible Patients with low-risk disease completely resected tumor or a single extra-abdominal site of involvement other than the mediastinum but without lymphoblastic lymphoma are assigned to treatment group 2 All other patients including those with lymphoblastic lymphoma without bone marrow involvement are considered high risk and they are assigned to treatment group 1
Group 1 high risk Patients receive one course of regimen A comprising CTX IV over 15 minutes on days 1-4 VCR IV on days 1 8 and 15 doxorubicin DOX IV on days 1 and 2 ARA-C IV over 3 hours every 12 hours on day 1 ARA-C IT on day 4 and MTX IT on days 8 and 12 Patients then receive one course of regimen B comprising ifosfamide IV over 30 minutes on days 1-5 etoposide IV over 1 hour and MTX IV on days 1-3 VCR IV on day 8 ARA-C IT on days 1 and 4 and MTX IT as in regimen A Patients then receive a second course of regimen A followed by a second course of regimen B
Group 2 low risk Patients receive one course of regimen A followed by one course of regimen B and then a second course of regimen A DOX is withheld during both courses of regimen A IT therapy is withheld during the second course of regimen A
Patients are followed every 2 months for 1 year Protocol MCP-841 or at 1 2 3 4 6 and 8 months Protocol MCP-842 every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 4000 patients will be accrued for this study
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 |
|---|---|---|---|
| OH92-C-0030 | None | None | None |
| NCI-92-C-0030 | None | None | None |
| NCI-T91-0259N | None | None | None |