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

ConditionsAcute Lymphoblastic Leukemia in RemissionAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid Leukemia in RemissionChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome With Excess BlastsRecurrent Acute Lymphoblastic LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRefractory Acute Myeloid LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRefractory Mixed Phenotype Acute LeukemiaHematopoietic and Lymphoid Cell Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

    Biological/Vaccine

    Given via infusion

  • Cyclophosphamide

    Drug

    Given IV

  • Total-Body Irradiation

    Radiation

    Undergo TBI

  • Peripheral Blood Stem Cell Transplantation

    Procedure/Surgery

    Undergo PBSC transplantation

  • Bone Marrow Transplantation

    Procedure/Surgery

    Undergo bone marrow transplant

  • Mycophenolate Mofetil

    Drug

    Given IV or PO

  • Recombinant Granulocyte Colony-Stimulating Factor

    Biological/Vaccine

    Given IV or SC

  • Fludarabine Phosphate

    Drug

    Given IV

  • Tacrolimus

    Drug

    Given IV or PO

  • Bone Marrow Aspiration and Biopsy

    Procedure/Surgery

    Undergo bone marrow biopsy and aspiration

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

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%.

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

Secondary outcomes

1

Achievement of remission

Time frame
Up to 2 years
2

Rate of engraftment

Time frame
Up to 2 years
3

Donor chimerism

Time frame
At days 28, 56, 84, 180, and at 1 year
4

Non-relapse mortality (NRM)

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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