What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, monoclonal antibodies, and stem cell transplants. Monoclonal antibodies, such as those used in the 211At-BC8-B10 trial, can cause infusion reactions, fever, chills, and fatigue. When combined with radioactive isotopes, additional side effects may include radiation sickness, nausea, and increased risk of infections due to bone marrow suppression. Chemotherapy often leads to side effects like hair loss, mouth sores, and gastrointestinal issues. Stem cell transplants carry risks of graft-versus-host disease, infections, and organ damage. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies and targeted therapies for the treatment of Acute Lymphoblastic Leukemia (ALL). Blinatumomab, a bispecific T-cell engager (BiTE) antibody, targets CD19 on B-cells and has been approved for relapsed or refractory B-cell precursor ALL. Inotuzumab ozogamicin, an antibody-drug conjugate targeting CD22, is another approved treatment for relapsed or refractory B-cell ALL. Additionally, the tyrosine kinase inhibitors imatinib and dasatinib are approved for Philadelphia chromosome-positive ALL. These treatments, like the 211At-BC8-B10 trial, utilize targeted approaches to attack cancer cells specifically.

What other types of research exist?

Promising novel alternatives to 211At-BC8-B10 for Acute Lymphoblastic Leukemia (ALL) patients include: 1) CAR T-cell therapy (e.g., tisagenlecleucel), which involves modifying a patient's T-cells to target and kill leukemia cells. 2) Bispecific T-cell engagers (BiTEs) like blinatumomab, which direct T-cells to attack leukemia cells. 3) Antibody-drug conjugates (ADCs) such as inotuzumab ozogamicin, which deliver cytotoxic agents directly to cancer cells. These therapies have shown significant efficacy in clinical trials and are considered promising options for ALL treatment.

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Monoclonal Antibodies

Radioimmunotherapy + Stem Cell Transplant for Leukemia and Myelodysplastic Syndrome

Phase 1 & 2

Waitlist Available

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

Must not have

DLCO < 35% or receiving supplemental continuous oxygen

Pregnant or breastfeeding women of childbearing potential

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 100 days after hematopoietic cell transplantation (hct)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a new treatment for patients with certain types of blood cancer that have returned or are not responding to treatment. The process includes treatments to clear out unhealthy cells, followed by a transplant of healthy cells from a donor to help rebuild the patient's blood cells.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung function is severely reduced or I need extra oxygen.

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I am currently pregnant or breastfeeding.

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I have had a bone marrow transplant from a donor.

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I am allergic to certain mouse-derived cancer drugs.

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I cannot undergo radiotherapy due to health reasons.

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I have liver issues such as cirrhosis or alcoholic hepatitis.

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My leukemia has spread to my brain or spinal cord.

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I am able to understand and give informed consent.

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I am fertile and not willing to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 100 days after hematopoietic cell transplantation (hct)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up 100 days after hematopoietic cell transplantation (hct)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 100 days after hematopoietic cell transplantation (hct) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Toxicity: Proportion of patients who develop grades III/IV Bearman regimen-related toxicity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Recombinant Granulocyte Colony-Stimulating Factor

2018

Completed Phase 2

~70

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Tacrolimus

2019

Completed Phase 4

~5510

Bone Marrow Aspiration and Biopsy

2016

Completed Phase 1

~40

Biospecimen Collection

2004

Completed Phase 3

~2020

Cyclophosphamide

2010

Completed Phase 4

~2310

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Total-Body Irradiation

1997

Completed Phase 3

~1180

Bone Marrow Transplantation

2012

Completed Phase 3

~270

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, monoclonal antibodies, and stem cell transplantation. Chemotherapy uses cytotoxic drugs to kill rapidly dividing leukemia cells, aiming to reduce the leukemia cell population to undetectable levels. Monoclonal antibodies, such as 211At-BC8-B10, are designed to target specific antigens on leukemia cells, delivering a radioactive isotope directly to the cancer cells to disrupt their growth and spread. This targeted approach minimizes damage to normal cells. Stem cell transplantation involves replacing the patient's diseased bone marrow with healthy stem cells from a donor, which can help restore normal blood cell production and immune function. These treatments are crucial for ALL patients as they aim to achieve complete remission, prevent relapse, and improve overall survival rates.

Recent advances in the treatment of acute leukemia: 1999.