A Phase 2 interventional study of iodine I 131 monoclonal antibody BC8 and busulfan in Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), sponsored by Fred Hutchinson Cancer Center. Completed at 3 sites in United States. Open to participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-08-30.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
This phase II trial studies how well iodine I 131 monoclonal antibody BC8, busulfan, and cyclophosphamide followed by donor stem cell transplant works in treating patients with acute myeloid leukemia that has decreased or disappeared, but the cancer may still be in the body. Giving chemotherapy drugs, such as busulfan and cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Also, radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the stem cells from a related donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PRIMARY OBJECTIVES:
I. To determine the efficacy (as measured by survival and disease-free survival) and toxicity of a regimen of busulfan 16 mg/kg and cyclophosphamide 120 mg/kg plus 131I-labeled anti-cluster of differentiation (CD) 45 antibody (iodine I 131 monoclonal antibody BC8) (delivering a dose of 5.25 gray [Gy] to the normal organ receiving the highest dose) in patients with acute myeloid leukemia (AML) in first remission receiving human leukocyte antigen (HLA)-identical related peripheral blood stem cell (PBSC) transplants.
OUTLINE:
RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 intravenously (IV) on day -13.
CHEMOTHERAPY: Patients receive busulfan orally (PO) every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Patients undergo allogeneic PBSC or bone marrow (BM) transplant on day 0.
GRAFT-VS-HOST DISEASE PREVENTION: Patients receive cyclosporine IV or PO every 12 hours on days -1 to 50 with a taper to day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up at 6, 9, and 12 months; every 6 months for 1 year; and then yearly thereafter.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 18 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
RADIOLABELED ANTIBODY: Patients receive iodine I 131 monoclonal antibody BC8 IV on day -13. CHEMOTHERAPY: Patients receive busulfan PO every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. TRANSPLANT: Patients undergo allogeneic PBSC or BM transplant on day 0. GRAFT-VS-HOST DISEASE PREVENTION: Patients receive cyclosporine IV or PO every 12 hours on days -1 to 50 with a taper to day 180. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Radiation: iodine I 131 monoclonal antibody BC8 · Drug: busulfan · Drug: cyclophosphamide · Procedure: allogeneic bone marrow transplantation · Procedure: allogeneic hematopoietic stem cell transplantation · Procedure: peripheral blood stem cell transplantation · Drug: cyclosporine · Drug: methotrexate · Other: laboratory biomarker analysis
Given IV
Also known as: I 131 MOAB BC8, I 131 Monoclonal Antibody BC8, iodine I 131 MOAB BC8
Given PO
Also known as: BSF, BU, Misulfan, Mitosan, Myeloleukon
Given IV
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Undergo allogeneic PBSC or bone marrow transplant
Also known as: bone marrow therapy, allogeneic, bone marrow therapy, allogenic, transplantation, allogeneic bone marrow, transplantation, allogenic bone marrow
Undergo allogeneic PBSC or bone marrow transplant
Undergo allogeneic PBSC or bone marrow transplant
Also known as: PBPC transplantation, PBSC transplantation, peripheral blood progenitor cell transplantation, transplantation, peripheral blood stem cell
Given IV or PO
Also known as: ciclosporin, cyclosporin, cyclosporin A, CYSP, Sandimmune
Given IV
Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX
Correlative studies
Disease-free survival (DFS)
Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Time frame: Up to 6 years
Overall survival (OS)
Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Time frame: Up to 6 years
Relapse of AML patients
Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Time frame: Up to 6 years
Transplant-related mortality
Transplant-related toxicities are graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2. Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Time frame: Up to 6 years
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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