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Monoclonal Antibodies
Radioimmunotherapy for Benign Conditions
Phase 1 & 2
Waitlist Available
Led By Phuong Vo
Research Sponsored by Fred Hutchinson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unrelated donor. Matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing; OR Mismatched for a single HLA-class 1 allele or HLA-DQB1 antigen or allele by high-resolution typing. Note: A donor homozygous for one allele only at HLA-A, B, C, DRB1, or DQB1 is allowed (1 antigen mismatch for graft versus host disease [GVHD], 0 antigen mismatch for graft-rejection). In the case of a recipient who is homozygous at one locus, the mismatch is not allowed to be at that locus (0 antigen mismatch for GVHD, 1 antigen mismatch for graft-rejection)
Lansky play performance score or Karnofsky score >= 70
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-transplant
Awards & highlights
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.
Who is the study for?
This trial is for adults under 50 with benign tumors treatable by stem cell transplant. They must have good performance scores, normal organ function, and a suitable donor (related or unrelated) matched to their HLA type. Pregnant or breastfeeding women, those unwilling to use contraception, and individuals with certain heart, lung, kidney or liver conditions are excluded.Check my eligibility
What is being tested?
The trial tests total body irradiation combined with Astatine-211-labeled BC8-B10 monoclonal antibody before hematopoietic cell transplantation in patients with nonmalignant diseases. It aims to find the best dose of radiation therapy that targets cancer cells without harming the patient's immune system.See study design
What are the potential side effects?
Potential side effects include reactions related to radiotherapy such as fatigue and skin irritation; complications from stem cell transplantation like infection risk; and possible adverse effects from monoclonal antibodies which could involve allergic reactions or organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My donor matches me closely in immune system markers, with at most one mismatch allowed.
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I am mostly active and can care for myself.
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My donor matches me closely in genetic markers and is preferably my sibling.
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I am between 18 and 49 years old.
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My donor shares one HLA type with me and may differ in others.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Graft rejection (arm A)
Graft rejection (arm B)
Secondary outcome measures
Donor chimerism
Overall survival
Rate of acute graft versus host disease (GVHD)
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)Experimental Treatment10 Interventions
Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 IV on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil PO or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total-Body Irradiation
1997
Completed Phase 3
~1180
Cyclophosphamide
1995
Completed Phase 3
~3770
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Biospecimen Collection
2004
Completed Phase 2
~1720
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Sirolimus
2013
Completed Phase 4
~2750
Fludarabine
2012
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,438 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,295 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart function is normal, and I don't need medication for heart failure or uncontrolled high blood pressure.My liver function is not severely impaired.I am not willing to use birth control during and for a year after treatment.My donor matches me closely in immune system markers, with at most one mismatch allowed.I am mostly active and can care for myself.My donor matches me closely in genetic markers and is preferably my sibling.I cannot be a donor if tests show my cells might not work with the recipient.I have a non-cancerous condition treatable with a stem cell transplant.I am allergic to certain mouse-derived cancer drugs.I am between 18 and 49 years old.My donor shares one HLA type with me and may differ in others.I have had a GI specialist evaluate me before my transplant.My liver iron concentration is below 7 mg/g, confirmed by an MRI.I have Fanconi Anemia.My kidney function is low, shown by tests or I'm on dialysis.My lung function is significantly impaired, as shown by tests or needing extra oxygen.My donor is chosen based on the best HLA match and tested in a CLIA-approved lab.I am pregnant or breastfeeding.I do not have any serious infections that would delay treatment, except for a common cold.I cannot undergo radiotherapy due to health reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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