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New treatment option for Acute Lymphoblastic Leukemia in Remission
Official title 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome
ClinicalTrials.gov ID: NCT03670966
What this study is testing
What is Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10?
Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10 is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for acute lymphoblastic leukemia in remission.
Also referred to as At 211 MAb BC8-B10, APAMISTAMAB-B10-ASTATINE AT-211.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- AML evolved from myelodysplastic or myeloproliferative syndromes;
You likely can't join if
- 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...
- Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices...
- Patients who are known to be seropositive for human immunodeficiency virus (HIV).
- Perceived inability to tolerate diagnostic or therapeutic procedures.
See the full eligibility criteria
- 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)
- 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...
- 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) \ = 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...
- 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...
- 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...
- Patients who are known to be seropositive for human immunodeficiency virus (HIV).
- Perceived inability to tolerate diagnostic or therapeutic procedures.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.