Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004907
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2000-03-07
Brief Title:
Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma Hodgkins Lymphoma or Non-Hodgkins Lymphoma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
High-Dose Chemoradiotherapy With Stem Cell Allogeneic Cellular Rescue in Patients With Relapsed or Refractory Hematologic Malignancy - A Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage cancer cells Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma Hodgkins lymphoma or non-Hodgkins lymphoma
PURPOSE Phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma Hodgkins lymphoma or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA identical related bone marrow or peripheral blood stem cell transplantation in patients with relapsed or refractory cutaneous T-cell lymphoma Hodgkins lymphoma or non-Hodgkins lymphoma
Determine the response rate and disease free survival in patients treated with this regimen
OUTLINE HLA identical related donors undergo harvest of bone marrow or peripheral blood stem cells PBSC
Patients are assigned to one of two treatment groups based on prior radiation to abdomen or mediastinum
Group A prior radiation no greater than 2000 cGy Patients with complete response CR or partial response PR after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -6 and -5 followed by total body irradiation twice daily on days -4 to -1 Patients with minimal response after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -8 and -7 followed by etoposide IV over 30 hours beginning on day -6 followed by total body irradiation twice daily on days -4 to -1
Group B prior radiation greater than 2000 cGy Patients with CR or PR after completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4 followed by cyclophosphamide IV over 1 hour on days -3 and -2 Patients with minimal response after completion of chemotherapy receive oral busulfan every 6 hours on days -9 to -6 followed by cyclophosphamide IV over 1 hour on days -5 and -4 followed by etoposide IV over 30 hours beginning on day -3
Both groups Bone marrow or PBSC are reinfused on day 0 Patients with bulky nodal disease greater than 5 cm may undergo involved field radiotherapy two weeks before transplantation
Patients are followed every month for 1 year
PROJECTED ACCRUAL Not specified
Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA identical related bone marrow or peripheral blood stem cell transplantation in patients with relapsed or refractory cutaneous T-cell lymphoma Hodgkins lymphoma or non-Hodgkins lymphoma
Determine the response rate and disease free survival in patients treated with this regimen
OUTLINE HLA identical related donors undergo harvest of bone marrow or peripheral blood stem cells PBSC
Patients are assigned to one of two treatment groups based on prior radiation to abdomen or mediastinum
Group A prior radiation no greater than 2000 cGy Patients with complete response CR or partial response PR after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -6 and -5 followed by total body irradiation twice daily on days -4 to -1 Patients with minimal response after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -8 and -7 followed by etoposide IV over 30 hours beginning on day -6 followed by total body irradiation twice daily on days -4 to -1
Group B prior radiation greater than 2000 cGy Patients with CR or PR after completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4 followed by cyclophosphamide IV over 1 hour on days -3 and -2 Patients with minimal response after completion of chemotherapy receive oral busulfan every 6 hours on days -9 to -6 followed by cyclophosphamide IV over 1 hour on days -5 and -4 followed by etoposide IV over 30 hours beginning on day -3
Both groups Bone marrow or PBSC are reinfused on day 0 Patients with bulky nodal disease greater than 5 cm may undergo involved field radiotherapy two weeks before transplantation
Patients are followed every month for 1 year
PROJECTED ACCRUAL Not specified
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-95H4T | None | None | None |
| NCI-G00-1692 | None | None | None |