Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392691
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2006-10-25
Brief Title:
Melphalan Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkins Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Ibritumomab Tiuxetan and High-Dose Melphalan as Conditioning Regimen Before Autologous Stem Cell Transplantation for Elderly Patients With Lymphoma in Relapse or Resistant to Chemotherapy A Multicenter Phase I Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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 Giving chemotherapy drugs such as melphalan before an autologous stem cell transplant helps stop the growth of cancer cells either by killing the cells or by stopping them from dividing Also monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can find cancer cells and carry cancer-killing substances to them without harming normal cells Chemotherapy and monoclonal antibody therapy also prepares the patients bone marrow for the stem cell transplant Giving colony-stimulating factors such as G-CSF and vinorelbine helps stem cells move from the bone marrow to the blood so they can be collected and stored The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and monoclonal antibody therapy
PURPOSE This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkins lymphoma that has relapsed or not responded to previous treatment
PURPOSE This phase I trial is studying the side effects and best dose of melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab followed by autologous stem cell transplant in treating older patients with non-Hodgkins lymphoma that has relapsed or not responded to previous treatment
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of high-dose melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab as a conditioning regimen followed by vinorelbine ditartrate- and filgrastim G-CSF-mobilized autologous stem cell transplantation in elderly patients with relapsed or refractory CD20-positive non-Hodgkins lymphoma
Evaluate the feasibility and safety of this regimen in these patients
Determine the feasibility of stem cell mobilization with vinorelbine ditartrate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of high-dose melphalan
Stem cell harvest and mobilization Patients receive vinorelbine ditartrate IV on day -36 and filgrastim G-CSF subcutaneously SC twice daily on days -33 to -29 Patients undergo peripheral blood stem cell harvest on days -29 to -26
Radioimmunotherapy Patients receive rituximab IV Within 4 hours after completion of rituximab patients receive indium In 111 ibritumomab tiuxetan imaging dose IV over 10 minutes on day -25 Patients undergo assessment of biodistribution imaging and dosimetry on days -25 -22 and optionally on day -20 Patients with acceptable biodistribution of indium In 111 ibritumomab tiuxetan receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan therapeutic dose IV over 10 minutes on day -18
High-dose chemotherapy Patients receive high-dose melphalan IV on day -1 Cohorts of 3-6 patients receive escalating doses of high-dose melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Autologous stem cell transplantation ASCT Patients undergo ASCT on day 0 Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover
After completion of study treatment patients are followed for 100 days
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Determine the maximum tolerated dose of high-dose melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab as a conditioning regimen followed by vinorelbine ditartrate- and filgrastim G-CSF-mobilized autologous stem cell transplantation in elderly patients with relapsed or refractory CD20-positive non-Hodgkins lymphoma
Evaluate the feasibility and safety of this regimen in these patients
Determine the feasibility of stem cell mobilization with vinorelbine ditartrate in patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of high-dose melphalan
Stem cell harvest and mobilization Patients receive vinorelbine ditartrate IV on day -36 and filgrastim G-CSF subcutaneously SC twice daily on days -33 to -29 Patients undergo peripheral blood stem cell harvest on days -29 to -26
Radioimmunotherapy Patients receive rituximab IV Within 4 hours after completion of rituximab patients receive indium In 111 ibritumomab tiuxetan imaging dose IV over 10 minutes on day -25 Patients undergo assessment of biodistribution imaging and dosimetry on days -25 -22 and optionally on day -20 Patients with acceptable biodistribution of indium In 111 ibritumomab tiuxetan receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan therapeutic dose IV over 10 minutes on day -18
High-dose chemotherapy Patients receive high-dose melphalan IV on day -1 Cohorts of 3-6 patients receive escalating doses of high-dose melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Autologous stem cell transplantation ASCT Patients undergo ASCT on day 0 Patients receive G-CSF SC beginning on day 5 and continuing until blood counts recover
After completion of study treatment patients are followed for 100 days
PROJECTED ACCRUAL A total of 24 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 |
|---|---|---|---|
| SWS-SAKK-3705 | None | None | None |
| EU-20648 | None | None | None |
| SPRI-SWS-SAKK-3705 | None | None | None |
| CDR0000511915 | None | None | None |