Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039377
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2002-06-06
Brief Title:
Chemotherapy Imatinib Mesylate and Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Sequential Chemotherapy Imatinib Mesylate Gleevec STI571 NSC 716051 and Transplantation for Adults With Newly Diagnosed Ph Acute Lymphoblastic Leukemia by the CALGB and SWOG
Status:
COMPLETED
Status Verified Date:
2014-06
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:
This phase II trial studies how well giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation works in treating patients with newly diagnosed acute lymphoblastic leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Giving imatinib mesylate together with chemotherapy and peripheral stem cell transplantation may be an effective treatment for acute lymphoblastic leukemia
Detailed Description:
PRIMARY OBJECTIVES
I Determine the activity of imatinib mesylate Gleevec to prolong disease-free survival DFS and overall survival in acute lymphoblastic leukemia ALL patients with t922
II Determine the ability of imatinib mesylate Gleevec to produce or maintain a BCR-ABL-negative status as judged by real-time-polymerase chain reaction RT-PCR following sequential chemotherapy imatinib mesylate Gleevec and transplantation
III Determine the feasibility of collecting adequate peripheral blood stem cells for autologous transplantation following imatinib mesylate Gleevec therapy
IV Study the safety and efficacy of autologous peripheral stem cell transplantation following therapy with imatinib mesylate Gleevec
V Study the safety and efficacy of allogeneic stem cell transplantation following therapy with imatinib mesylate Gleevec
VI Study the safety and efficacy of imatinib mesylate Gleevec administered after allogeneic or autologous stem cell transplant
OUTLINE
COURSE I remission induction Patients receive 1 course of front-line induction therapy on a Cancer and Leukemia Group B CALGBSouthwest Oncology Group SWOG protocol prior to enrollment
COURSE II imatinib mesylate Patients receive imatinib mesylate orally PO twice daily on days 1-28
COURSE III CNS prophylaxis Within 7 days after completing course II patients receive methotrexate intrathecally IT methotrexate intravenously IV over 3 hours and vincristine sulfate IV on days 1 8 and 15 methotrexate PO every 6 hours on days 1-2 8-9 and 15-16 leucovorin calcium IV on days 2 9 and 16 and leucovorin calcium PO every 6 hours on days 3 4 10 11 17 and 18
COURSE IV imatinib mesylate After blood counts recover after completion of course III patients receive imatinib mesylate as in course II
COURSE V Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT autologous PBSCT or no PBSCT
COURSE Va allogeneic PBSCT for patients with human leukocyte antigen HLA-matched sibling donor Beginning 3-10 days after completion of course IV patients with an HLA-matched sibling donor undergo total body irradiation TBI 2-3 times daily on days -7 to -4 Patients receive etoposide IV over 4 hours on day -3 Patients then undergo PBSCT on day 0 Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56 followed by a taper Patients also receive methotrexate IV on days 1 3 and 6 and filgrastim subcutaneously SC beginning on day 4 and continuing until blood counts recover
COURSE Vb autologous PBSCT for patients without HLA-matched sibling donor Beginning 3-10 days after completion of course IV patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4 Patients also receive filgrastim SC beginning on day 14 and continuing until PBSC collection is complete Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT Patients then undergo TBI 2-3 times daily on days -8 to -5 Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 Patients undergo PBSCT on day 0 Patients receive filgrastim SC beginning on day 0 and continuing until blood counts recover
COURSE Vc no transplantation for patients who are not transplant candidates Beginning 3-10 days after completion of course IV patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4 Patients also receive filgrastim SC once or twice a day beginning on day 14 and continuing until blood counts recover
COURSE VI Patients receive imatinib mesylate PO once or twice daily beginning on day 30 post transplantation or on day 30 if no transplantation received and continuing for at least 1 year or until patient has 2 consecutive negative reverse transcriptase-polymerase chain reaction assays at least 3 months apart or until relapse
After completion of study treatment patients are followed up monthly for 1 year every 3 months for 2 years every 6 months for 2 years then yearly for 5 years
I Determine the activity of imatinib mesylate Gleevec to prolong disease-free survival DFS and overall survival in acute lymphoblastic leukemia ALL patients with t922
II Determine the ability of imatinib mesylate Gleevec to produce or maintain a BCR-ABL-negative status as judged by real-time-polymerase chain reaction RT-PCR following sequential chemotherapy imatinib mesylate Gleevec and transplantation
III Determine the feasibility of collecting adequate peripheral blood stem cells for autologous transplantation following imatinib mesylate Gleevec therapy
IV Study the safety and efficacy of autologous peripheral stem cell transplantation following therapy with imatinib mesylate Gleevec
V Study the safety and efficacy of allogeneic stem cell transplantation following therapy with imatinib mesylate Gleevec
VI Study the safety and efficacy of imatinib mesylate Gleevec administered after allogeneic or autologous stem cell transplant
OUTLINE
COURSE I remission induction Patients receive 1 course of front-line induction therapy on a Cancer and Leukemia Group B CALGBSouthwest Oncology Group SWOG protocol prior to enrollment
COURSE II imatinib mesylate Patients receive imatinib mesylate orally PO twice daily on days 1-28
COURSE III CNS prophylaxis Within 7 days after completing course II patients receive methotrexate intrathecally IT methotrexate intravenously IV over 3 hours and vincristine sulfate IV on days 1 8 and 15 methotrexate PO every 6 hours on days 1-2 8-9 and 15-16 leucovorin calcium IV on days 2 9 and 16 and leucovorin calcium PO every 6 hours on days 3 4 10 11 17 and 18
COURSE IV imatinib mesylate After blood counts recover after completion of course III patients receive imatinib mesylate as in course II
COURSE V Patients undergo allogeneic peripheral blood stem cell transplantation PBSCT autologous PBSCT or no PBSCT
COURSE Va allogeneic PBSCT for patients with human leukocyte antigen HLA-matched sibling donor Beginning 3-10 days after completion of course IV patients with an HLA-matched sibling donor undergo total body irradiation TBI 2-3 times daily on days -7 to -4 Patients receive etoposide IV over 4 hours on day -3 Patients then undergo PBSCT on day 0 Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56 followed by a taper Patients also receive methotrexate IV on days 1 3 and 6 and filgrastim subcutaneously SC beginning on day 4 and continuing until blood counts recover
COURSE Vb autologous PBSCT for patients without HLA-matched sibling donor Beginning 3-10 days after completion of course IV patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4 Patients also receive filgrastim SC beginning on day 14 and continuing until PBSC collection is complete Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT Patients then undergo TBI 2-3 times daily on days -8 to -5 Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2 Patients undergo PBSCT on day 0 Patients receive filgrastim SC beginning on day 0 and continuing until blood counts recover
COURSE Vc no transplantation for patients who are not transplant candidates Beginning 3-10 days after completion of course IV patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4 Patients also receive filgrastim SC once or twice a day beginning on day 14 and continuing until blood counts recover
COURSE VI Patients receive imatinib mesylate PO once or twice daily beginning on day 30 post transplantation or on day 30 if no transplantation received and continuing for at least 1 year or until patient has 2 consecutive negative reverse transcriptase-polymerase chain reaction assays at least 3 months apart or until relapse
After completion of study treatment patients are followed up monthly for 1 year every 3 months for 2 years every 6 months for 2 years then yearly for 5 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-2009-00436 | REGISTRY | None | None |
| CDR0000069378 | None | None | None |
| CALGB 10001SWOG C10001 | OTHER | None | None |
| CALGB-10001 | OTHER | None | None |
| U10CA031946 | NIH | CTEP | httpsreporternihgovquickSearchU10CA031946 |