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Acute Lymphoblastic Leukemia in RemissionPhase 1/2NCT03670966

211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

A Phase 1/2 study testing Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Cyclophosphamide and Total-Body Irradiation in people with Acute Lymphoblastic Leukemia in Remission and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Cyclophosphamide and Total-Body Irradiation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
10 Jul 2019to 20 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:
  • AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;
  • AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);
  • AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);
  • AML evolved from myelodysplastic or myeloproliferative syndromes;
  • MDS expressed as refractory anemia with excess blasts (RAEB)
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  • Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.
  • Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow).
  • Patients must be >= 18 and =< 75 years of age.
  • Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed).
  • Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.
  • Total bilirubin within normal limits
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times the upper limit of normal.
  • Eastern Cooperative Oncology Group (ECOG) < 2 or Karnofsky >= 70.
  • Patients must be free of uncontrolled infection.
  • Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.
  • Patients must have normal elastography.
  • If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI).
  • Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.
  • Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.
  • DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.

Who cannot join

  • Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.
  • Left ventricular ejection fraction < 45%.
  • Corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of < 89% during a 6MWT will be excluded
  • Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.
  • Patients who are known to be seropositive for human immunodeficiency virus (HIV).
  • Perceived inability to tolerate diagnostic or therapeutic procedures.
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  • Active central nervous system (CNS) leukemia at time of treatment.
  • Patients with prior myeloablative allogeneic-HCT.
  • Women of childbearing potential who are pregnant (beta human chorionic gonadotropin [B-HCG]+) or breast feeding.
  • Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.
  • Inability to understand or give an informed consent.
  • Allergy to murine-based monoclonal antibodies.
  • Known contraindications to radiotherapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Phuong Vo contact

206-667-2749

ptvo@fredhutch.org

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    Phuong Vo, 206-667-2749, ptvo@fredhutch.org

    Phuong Vo

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)

This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.

Read the detailed description

OUTLINE: This is a dose-escalation study of astatine At 211 anti-CD45 monoclonal antibody BC8-B10.

PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine intravenously (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 peripheral blood stem cell (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 three times daily (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 granulocyte colony-stimulating factor (G-CSF) IV or subcutaneously (SC) on day 5 to continue until absolute neutrophil count (ANC) > 1000/mm^3 x 3 days.

Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at day 100, and at 6, 9, 12, 18, and 24 months.

Being tested
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Cyclophosphamide, Total-Body Irradiation, Peripheral Blood Stem Cell Transplantation, Bone Marrow Transplantation
Keywords
Lymphoid Leukemia, Myeloid and Monocytic Leukemia, Other Hematopoietic
Medical subject headings
Leukemia, Myelomonocytic, Chronic, Anemia, Refractory, with Excess of Blasts, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, Hematologic Neoplasms, Leukemia, Lymphoid, Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10Biological

    Also called At 211 MAb BC8-B10, APAMISTAMAB-B10-ASTATINE AT-211

    Given via infusion

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, Asta B 518, B-518, WR-138719

    Given IV

  • Total-Body IrradiationRadiation

    Also called Total Body Irradiation, SCT_TBI, Whole Body Irradiation, Whole-Body Irradiation

    Undergo TBI

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation

    Undergo PBSC transplantation

  • Bone Marrow TransplantationProcedure or surgery

    Also called Bone Marrow Grafting, BMT

    Undergo bone marrow transplant

  • Mycophenolate MofetilDrug

    Also called 115007-34-6, MMF, Cellcept

    Given IV or PO

  • Recombinant Granulocyte Colony-Stimulating FactorBiological

    Also called 143011-72-7, Recombinant Colony-Stimulating Factor 3, rhG-CSF

    Given IV or SC

  • Fludarabine PhosphateDrug

    Also called 2-F-ara-AMP, Beneflur, Fludara, Fludarabine-5''-Monophosphate

    Given IV

  • TacrolimusDrug

    Also called Prograf, Protopic, FK 506, FK-506

    Given IV or PO

  • Bone Marrow Aspiration and BiopsyProcedure or surgery

    Undergo bone marrow biopsy and aspiration

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood sample collection

Study groups in NCT03670966
Study groupRoleWhat they receive
Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)ExperimentalPREPARATIVE 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.
Receives: Biological: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10; Drug: Cyclophosphamide; Radiation: Total-Body Irradiation; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Bone Marrow Transplantation; Drug: Mycophenolate Mofetil; Biological: Recombinant Granulocyte Colony-Stimulating Factor; Drug: Fludarabine Phosphate; Drug: Tacrolimus; Procedure: Bone Marrow Aspiration and Biopsy; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity (DLT)

    DLT is defined as a grade III/IV regimen-related toxicity (Bearman scale). The maximum tolerated dose will be defined as the dose of 211^At-BC8-B10 used in combination with the reduced-intensity hematopoietic cell transplantation conditioning regimen that is associated with a grade III/IV regimen-related toxicity or true DLT rate of 25%. The data, thereby generating a dose-response curve based on the observed toxicity rate at the various dose levels visited. Based on this fitted model, the maximum tolerated dose is estimated to be the dose that is associated with a toxicity rate of 25%.

    Measured: Up to 30 days post-transplant, with a review period for occurrence of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) extended to 60 days post-transplant

Secondary outcomes (9)

  1. Achievement of remission

    Measured: Up to 2 years

  2. Rate of engraftment

    Measured: Up to 2 years

  3. Donor chimerism

    Measured: At days 28, 56, 84, 180, and at 1 year

  4. Non-relapse mortality (NRM)

    Measured: Up to 2 years

  5. Number of patients experiencing Immune reconstitution

    Measured: Up to 2 years

  6. Number of patients experiencing Number of Grade II-IV acute graft versus host disease (GVHD)

    Measured: Up to 2 years

  7. Number of patients experiencing Moderate/severe chronic GVHD

    Measured: Up to 2 years

  8. Overall survival

    Measured: Up to 100 days

  9. Disease-free survival

    Measured: Up to day 100

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start10 Jul 2019
  3. Primary completion28 Jan 2028 (estimated)
  4. Study completion20 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670966
Sponsor's protocol ID
RG1003349
Other IDs
10060, P30CA015704, NCI-2018-01788, P01CA078902
Status last verified
Jun 2026
First submitted
12 Sep 2018
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10, Cyclophosphamide and Total-Body Irradiation in people with Acute Lymphoblastic Leukemia in Remission and Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Phuong Vo (206-667-2749, ptvo@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (DLT) (time frame: Up to 30 days post-transplant, with a review period for occurrence of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) extended to 60 days post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670966.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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