Study Summary
This trial is testing the best dose of radiation to give with an antibody that targets cancer cells, in order to prepare patients for a stem cell transplant.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Up to 5 years post-transplant
At 1 year post-transplant
Overall survival
Rate of chronic GVHD
At day 100 post-transplant
Rate of acute graft versus host disease (GVHD)
Transplant related mortality
Year 1
Donor chimerism
Year 5
Graft rejection (arm A)
Graft rejection (arm B)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Hematopoietic Cell Transplantation · No Placebo Group · Phase 1 & 2
Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)Experimental Group · 8 Interventions: Mycophenolate Mofetil, Sirolimus, Fludarabine, Cyclophosphamide, Total-Body Irradiation, Hematopoietic Cell Transplantation, Lapine T-Lymphocyte Immune Globulin, Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 · Intervention Types: Drug, Drug, Drug, Drug, Radiation, Procedure, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved
Sirolimus
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Total-Body Irradiation
1997
Completed Phase 3
~1220
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~270
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years post-transplant
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
530 Previous Clinical Trials
1,303,777 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,101 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,592 Previous Clinical Trials
46,945,754 Total Patients Enrolled
Phuong VoPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
110 Total Patients Enrolled
Eligibility Criteria
Age 18 - 49 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are not related to the donor.
You are matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing.
You have a nonmalignant disease that is treatable by allogeneic hematopoietic cell transplantation (HCT).
Note: A donor homozygous for one allele only at HLA-A, B, C, DRB1, or DQB1 is allowed (1 antigen mismatch for GVHD, 0 antigen mismatch for graft-rejection).
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Conditions
Cancer Related
Treatments