Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281879
Status:
TERMINATED
Last Update Posted:
2017-09-27
First Post:
2006-01-24
Brief Title:
Donor Stem Cell Transplant or Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Transplantation of Unrelated Donor Hematopoietic Stem Cells for the Treatment of Hematological Malignancies
Status:
TERMINATED
Status Verified Date:
2017-09
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 A peripheral stem cell transplant or an umbilical cord blood transplant from a donor may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy Giving an infusion of the donors white blood cells donor lymphocyte infusion after the transplant may help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells can make an immune response against the bodys normal cells Methotrexate cyclosporine tacrolimus or methylprednisolone may stop this from happening
PURPOSE This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer
PURPOSE This clinical trial is studying how well a donor stem cell transplant or donor white blood cell infusions work in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of patients with high-risk hematologic malignancies
Compare survival disease-free survival DFS response rate and toxicity rates in these patients with historical controls
Compare the rate and severity of acute and chronic GVHD after allogeneic hematopoietic stem cell transplantation in patients with hematopoietic malignancies with historical controls transplanted with stem cells from related sibling donors
Assess engraftment long-term hematopoietic recovery relapse rate and disease-free survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients with high-risk hematological malignancies
Assess engraftment long-term hematopoietic recovery and overall survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients who have graft failure or graft rejection
Compare engraftment long-term hematopoietic recovery rate of GVHD rate of relapse toxicity rates overall disease-free survival and overall survival when donor leukocyte infusions DLI are given for patients who have disease recurrence progression or low donor chimerisms after unrelated stem cell transplantation or before DLI with historical controls of other donor leukocyte infusions
Secondary
Determine the quality of life of patients undergoing hematopoietic stem cell transplantation or donor leukocyte infusions from unrelated HLA genotypically-identical donors
OUTLINE Patients are assigned to 1 of 8 treatment groups
Group 1 Patients undergo total body irradiation TBI twice a day on days -7 to -4 Patients then receive cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo stem cell transplantation SCT Beginning on day 7 patients receive filgrastim G-CSF IV once daily until blood counts recover
Group 2 patients who have previously experienced dose-limiting radiotherapy Patients receive oral busulfan 4 times daily on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo SCT Beginning on day 7 patients receive G-CSF IV once daily until blood counts recover
Group 3 pediatric patients only Patients receive busulfan IV 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour and fludarabine IV over 30 minutes on days -5 to -2 On day 0 patients undergo SCT Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
Group 4 second SCT for patients who have experienced graft rejection or failure Patients receive low-dose fludarabine IV over 30 minutes on days -4 to -2 Patients then undergo low-dose TBI once followed by SCT on day 0 Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
Group 5 patients who developed grade 3 cystitis after prior cyclophosphamide-containing therapy Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 2 hours and cytarabine IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -1 BEAM On day 0 patients undergo SCT Beginning on day 7 patients receive G-CSF IV once daily until blood counts recover
Group 6 cord blood transplantation Patients receive anti-thymocyte globulin IV once daily and methylprednisolone IV twice daily on days -3 to -1 On day 0 patients undergo an umbilical cord blood SCT
Group 7 patients with relapsing or progressive disease after prior transplants or low donor chimerisms Patients must not have existing graft-versus-host disease GVHD Patients receive donor lymphocyte infusions with conditioning chemotherapy andor radiotherapy at the discretion of the investigator
Group 8 pediatric patients only Patients undergo TBI twice a day on days -7 to -5 Patients also receive etoposide IV over 24 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo SCT Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
NOTE Patients who have received 3000 cGy to the central nervous system or 2000 cGy to the lung or liver may not receive any regimen containing total body irradiation TBI
All patients receive GVHD prophylaxis comprising methotrexate IV on days 1 3 6 and 11 cyclosporine andor tacrolimus on days -2 to 100 andor methylprednisolone IV on days 7 to 100
Patients with an unrelated donor who experience a relapse prior to transplantation may proceed directly to transplantation However if immediate transplantation from the unrelated donor is not possible the patient must be re-induced into a complete hematological remission Patients who experience graft failure or graft rejection after allogeneic transplantation are eligible for a second stem cell infusion from the original donor
Quality of life is assessed at baseline and at 7 days 3 months and 1 year after transplantation
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 43 patients will be accrued for this study
Primary
Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of patients with high-risk hematologic malignancies
Compare survival disease-free survival DFS response rate and toxicity rates in these patients with historical controls
Compare the rate and severity of acute and chronic GVHD after allogeneic hematopoietic stem cell transplantation in patients with hematopoietic malignancies with historical controls transplanted with stem cells from related sibling donors
Assess engraftment long-term hematopoietic recovery relapse rate and disease-free survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients with high-risk hematological malignancies
Assess engraftment long-term hematopoietic recovery and overall survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients who have graft failure or graft rejection
Compare engraftment long-term hematopoietic recovery rate of GVHD rate of relapse toxicity rates overall disease-free survival and overall survival when donor leukocyte infusions DLI are given for patients who have disease recurrence progression or low donor chimerisms after unrelated stem cell transplantation or before DLI with historical controls of other donor leukocyte infusions
Secondary
Determine the quality of life of patients undergoing hematopoietic stem cell transplantation or donor leukocyte infusions from unrelated HLA genotypically-identical donors
OUTLINE Patients are assigned to 1 of 8 treatment groups
Group 1 Patients undergo total body irradiation TBI twice a day on days -7 to -4 Patients then receive cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo stem cell transplantation SCT Beginning on day 7 patients receive filgrastim G-CSF IV once daily until blood counts recover
Group 2 patients who have previously experienced dose-limiting radiotherapy Patients receive oral busulfan 4 times daily on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo SCT Beginning on day 7 patients receive G-CSF IV once daily until blood counts recover
Group 3 pediatric patients only Patients receive busulfan IV 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour and fludarabine IV over 30 minutes on days -5 to -2 On day 0 patients undergo SCT Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
Group 4 second SCT for patients who have experienced graft rejection or failure Patients receive low-dose fludarabine IV over 30 minutes on days -4 to -2 Patients then undergo low-dose TBI once followed by SCT on day 0 Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
Group 5 patients who developed grade 3 cystitis after prior cyclophosphamide-containing therapy Patients receive carmustine IV over 2 hours on day -6 etoposide IV over 2 hours and cytarabine IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -1 BEAM On day 0 patients undergo SCT Beginning on day 7 patients receive G-CSF IV once daily until blood counts recover
Group 6 cord blood transplantation Patients receive anti-thymocyte globulin IV once daily and methylprednisolone IV twice daily on days -3 to -1 On day 0 patients undergo an umbilical cord blood SCT
Group 7 patients with relapsing or progressive disease after prior transplants or low donor chimerisms Patients must not have existing graft-versus-host disease GVHD Patients receive donor lymphocyte infusions with conditioning chemotherapy andor radiotherapy at the discretion of the investigator
Group 8 pediatric patients only Patients undergo TBI twice a day on days -7 to -5 Patients also receive etoposide IV over 24 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2 On day 0 patients undergo SCT Beginning on day 7 patients may receive G-CSF IV once daily until blood counts recover
NOTE Patients who have received 3000 cGy to the central nervous system or 2000 cGy to the lung or liver may not receive any regimen containing total body irradiation TBI
All patients receive GVHD prophylaxis comprising methotrexate IV on days 1 3 6 and 11 cyclosporine andor tacrolimus on days -2 to 100 andor methylprednisolone IV on days 7 to 100
Patients with an unrelated donor who experience a relapse prior to transplantation may proceed directly to transplantation However if immediate transplantation from the unrelated donor is not possible the patient must be re-induced into a complete hematological remission Patients who experience graft failure or graft rejection after allogeneic transplantation are eligible for a second stem cell infusion from the original donor
Quality of life is assessed at baseline and at 7 days 3 months and 1 year after transplantation
After completion of study treatment patients are followed periodically for survival
PROJECTED ACCRUAL A total of 43 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 |
|---|---|---|---|
| OHSU-540 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016058 |
| P30CA016058 | NIH | None | None |
| OHSU-TPI-9695-L | None | None | None |