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Monoclonal Antibodies

Radioimmunotherapy for Benign Conditions

Phase 1 & 2
Recruiting
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 below
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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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-transplant for reporting.

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 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)Experimental Treatment8 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total-Body Irradiation
1997
Completed Phase 3
~1180
Hematopoietic Cell Transplantation
2006
Completed Phase 2
~360
Cyclophosphamide
1995
Completed Phase 3
~3770
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Sirolimus
2013
Completed Phase 4
~2750
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,228 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,205 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,835 Previous Clinical Trials
47,310,630 Total Patients Enrolled

Media Library

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04083183 — Phase 1 & 2
Benign Tumors Research Study Groups: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)
Benign Tumors Clinical Trial 2023: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 Highlights & Side Effects. Trial Name: NCT04083183 — Phase 1 & 2
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083183 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this medical experiment still being accepted?

"According to the data housed on clinicaltrials.gov, this trial is accepting enrollments. It was initially posted in June of 2020 and most recently modified in August 2022."

Answered by AI

Does this clinical trial include geriatric participants?

"To participate in this clinical trial, individuals must be between 18 and 49 years old. Subsequently, there are 368 trials available to people under 18 while 784 studies aim at helping seniors over 65."

Answered by AI

What criteria must individuals meet in order to join this research trial?

"This trial has 40 positions available for individuals aged 18-49 who have neoplasms. To be eligible, they must show a Lansky Play Performance score or Karnofsky Score of 70+ and either have an unrelated donor matched at the HLA-A, -B, -C, DRIB1 and DQB1 loci with high resolution typing; mismatched for one single HLA class 1 allele or DQB antigen/allele by high resolution typing; related to their donor genotypically & phenotypically similar (HLA); possess a nonmalignant disease treatable by allogeneic hematopoiet"

Answered by AI

Could you tell me the amount of participants enrolled in this research?

"Indeed, clinicaltrials.gov suggests this research initiative is actively seeking volunteers; it was originally posted on June 16th 2020 and its most recent update was August 29th 2022. This trial requires the recruitment of 40 individuals across a single site."

Answered by AI

What particular ailments is Hematopoietic Cell Transplantation employed to combat?

"Hematopoietic Cell Transplantation is a successful therapeutic intervention for organ transplant recipients, immunosuppressed patients and those suffering from multiple sclerosis."

Answered by AI

What other investigations into Hematopoietic Cell Transplantation have been conducted?

"1039 active trials are currently exploring the use of Hematopoietic Cell Transplantation, with 186 in Phase 3. Philadelphia, Pennsylvania is home to a majority of these research studies; however, there are also 29920 sites worldwide performing clinical tests for this therapy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
2020. "Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04083183.
~20 spots leftby Jan 2028
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