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Monoclonal Antibodies

Radioimmunotherapy + Stem Cell Transplant for Leukemia and Myelodysplastic Syndrome

Phase 1 & 2
Recruiting
Led By Phuong Vo
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG < 2 or Karnofsky >= 70
DONOR: Donors must meet specific HLA matching criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is studying the side effects and best dose of a radioactive agent linked to an antibody when given with a donor stem cell transplant to treat patients with high-risk leukemia or myelodysplastic syndrome.

Who is the study for?
This trial is for adults aged 18-75 with high-risk acute leukemia or myelodysplastic syndrome that's recurrent or refractory. Eligible patients must have certain types of leukemia, adequate organ function, and no uncontrolled infections. They can't have an HLA-matched donor available, severe heart/liver conditions, active HIV/CNS leukemia, be pregnant/breastfeeding, or unable to consent.Check my eligibility
What is being tested?
The trial tests a radioactive antibody (211At-BC8-B10) followed by a stem cell transplant from a donor to treat high-risk blood cancers. It includes chemotherapy and total body irradiation to prepare the bone marrow for new cells and medications post-transplant to prevent graft versus host disease.See study design
What are the potential side effects?
Possible side effects include reactions to the monoclonal antibody such as allergies, radiation toxicity affecting various organs due to total-body irradiation, complications from chemotherapy like nausea and hair loss, infection risk increase after stem cell transplantation, and potential graft versus host disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities without help.
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My tissue type matches the recipient's requirements.
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I do not have any infections that aren't responding to treatment.
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I have been diagnosed with AML, ALL, high-risk MDS, or MPAL.
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I am between 18 and 75 years old.
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I do not have a specific type of compatible donor for a transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity: Proportion of patients who develop grades III/IV Bearman regimen-related toxicity
Secondary outcome measures
Achievement of remission
Disease-free survival
Donor chimerism
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)Experimental Treatment11 Interventions
PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine IV over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Patients also undergo TBI on day -1. TRANSPLANT: Patients undergo PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID on days 5-35, and tacrolimus IV over 1-2 hours (changed to PO once tolerated) on days 5-180 with taper beginning on day 84 per physician discretion. Patients also begin G-CSF IV or SC on day 5 to continue until ANC > 1000/mm^3 x 3 days. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Total-Body Irradiation
1997
Completed Phase 3
~1180
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Recombinant Granulocyte Colony-Stimulating Factor
2018
Completed Phase 2
~70
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Bone Marrow Transplantation
2012
Completed Phase 3
~270
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,215 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,185 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,365 Total Patients Enrolled

Media Library

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03670966 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 Highlights & Side Effects. Trial Name: NCT03670966 — Phase 1 & 2
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03670966 — Phase 1 & 2

Frequently Asked Questions

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

Are there any specific requirements for people who want to join this clinical trial?

"This study is only for myeloid leukemia patients aged 18-75. Around 30 people will be accepted in total."

Answered by AI

Does this study require all participants to be over the age of 60?

"Eligibility criteria for this trial include being between 18-75 years old."

Answered by AI

How many volunteers are being sought for this experiment?

"The clinical trial is currently ongoing and recruiting patients, as reflected on the website clinicaltrials.gov. This study was posted on 7/10/2019, with the most recent update taking place on 10/24/2022. They are looking for 30 individuals total from 1 location."

Answered by AI

What types of diseases or conditions is Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 usually prescribed for?

"The application of Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 can be used to treat leukemia, infection, and bone marrow transplant patients."

Answered by AI

Are there any patients participating in this clinical trial at the moment?

"That is correct, the online information regarding this clinical trial indicates that it is still recruiting patients. This study was first posted on 7/10/2019 and edited for the last time on 10/24/2022. Currently, 30 people are needed to participate at 1 location."

Answered by AI

Are there similar ongoing or completed studies that involve the use of Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10?

"There are a total of 1110 ongoing studies related to the efficacy of Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10. Of these, 202 have progressed to phase 3 clinical trials. Additionally, although many of the Philadelphia based trials are for this treatment, there are 31166 locations running similar investigations."

Answered by AI
~6 spots leftby Jun 2025