Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048399
Status:
TERMINATED
Last Update Posted:
2020-01-18
First Post:
2002-10-30
Brief Title:
Stem Cell Transplantation for Patients With Graft Failure Following an Allogeneic Transplant Using Identical or Near Identical Donors and Less Toxic Conditioning With CAMPATH 1H
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Phase III Study of Allogeneic Stem Cell Transplantation For Patients With Graft Failure Following Allogeneic Transplantation Using MHC Identical or Near Identical Donors and Submyeloablative Conditioning With CAMPATH 1H CAMGRAFT
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
accrual was slow
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety feasibility and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H used as a preparative regimen for HLA-identical sibling blood stem cell transplantation SCT
To assess the safety feasibility and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a preparative regimen for matched unrelated or single antigen mismatched family donor marrow transplantation
To assess the safety feasibility and rate of donor engraftment for patients with primary or secondary engraftment failure after treatment with fludarabine and CAMPATH 1H as a preparative regimen for matched unrelated or single antigen mismatched family donor marrow transplantation
Detailed Description:
Study participants will receive the following treatment
Day -5 to -2Fludarabine 30mgm2 and CAMPATH 1H 10mg IV
Day -1Day of rest
Day 0Stem cell transplant infusion
Where possible patients will receive peripheral blood stem cells When peripheral stem cells are unavailable eg from some unrelated donor centers or insufficient bone marrow will be substituted If peripheral blood stem cell collection is performed the donor will be stimulated with G-CSF for 5 days and cells collected and frozen until the stem cell target number is obtained prior to the patient beginning the therapy If a bone marrow harvest is performed this will be performed on Day 0 infusion day After transplantation G-CSF 5 microgramskgday will be administered SC from day 7 until granulocytes 1000ul
Because CAMPATH-1H infusions will provide a persisting level of antibody over the transplant period it will contribute to anti-GvHD activity Additional GVHD prophylaxis will consist of FK506 administered IV via continuous infusion over 24 hours from Day-2 until engraftment or when the patient is able to take by mouth every 12 hours This is continued until 6 months post-transplantation The dose is then tapered every 2 weeks until discontinued All patients will receive supportive care prophylaxis for antimicrobial antiviral antifungal and Pneumocystis Pneumonia transfusions of blood products and intravenous gamma globulin and routine laboratory testing of chemistry and complete blood counts as per Cell and Gene Therapy Standard Operating Procedures SOP
Donor engraftment will be evaluated via standard bone marrow studies cytogeneticsDNA studies for chimerism on days 30 60 100 180 and 365 post transplantation If these studies reveal loss of donor cells on two consecutive studies andor evidence of relapsing disease the donor will undergo a peripheral blood stem cell harvest via G-CSF stimulation
Day -5 to -2Fludarabine 30mgm2 and CAMPATH 1H 10mg IV
Day -1Day of rest
Day 0Stem cell transplant infusion
Where possible patients will receive peripheral blood stem cells When peripheral stem cells are unavailable eg from some unrelated donor centers or insufficient bone marrow will be substituted If peripheral blood stem cell collection is performed the donor will be stimulated with G-CSF for 5 days and cells collected and frozen until the stem cell target number is obtained prior to the patient beginning the therapy If a bone marrow harvest is performed this will be performed on Day 0 infusion day After transplantation G-CSF 5 microgramskgday will be administered SC from day 7 until granulocytes 1000ul
Because CAMPATH-1H infusions will provide a persisting level of antibody over the transplant period it will contribute to anti-GvHD activity Additional GVHD prophylaxis will consist of FK506 administered IV via continuous infusion over 24 hours from Day-2 until engraftment or when the patient is able to take by mouth every 12 hours This is continued until 6 months post-transplantation The dose is then tapered every 2 weeks until discontinued All patients will receive supportive care prophylaxis for antimicrobial antiviral antifungal and Pneumocystis Pneumonia transfusions of blood products and intravenous gamma globulin and routine laboratory testing of chemistry and complete blood counts as per Cell and Gene Therapy Standard Operating Procedures SOP
Donor engraftment will be evaluated via standard bone marrow studies cytogeneticsDNA studies for chimerism on days 30 60 100 180 and 365 post transplantation If these studies reveal loss of donor cells on two consecutive studies andor evidence of relapsing disease the donor will undergo a peripheral blood stem cell harvest via G-CSF stimulation
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 |
|---|---|---|---|
| CAMGRAFT | None | None | None |