Clinical trial · Interventional
Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in First Remission
Phase II Study of Radiolabeled BC8 (Anti-CD45) Antibody Combined With Busulfan and Cyclophosphamide as Treatment for Acute Myelogenous Leukemia in First Remission Followed by HLA-Identical Related Peripheral Blood Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Del(5q) | Acute Myeloid Leukemia with del(5q) | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| iodine I 131 monoclonal antibody BC8 | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| methotrexate | Drug | Methotrexate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiolabeled BC8, chemotherapy, PBSCT)
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with AML in first remission * Creatinine \< 2.0 mg/dl * Bilirubin \< 1.5 mg/dl which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver * Aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal which is expected to exclude patients at high risk of developing veno-occlusive disease of the liver * Patients must have an expected survival of \> 60 days and must be free of major infection * DONOR: genotypic or phenotypic HLA-matched family members; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DR beta 1 (DRB1) according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQ beta 1 (DQB1) Exclusion Criteria: * Patients with history of or current leukemic involvement of the central nervous system (CNS) * Prior radiation to maximally tolerated levels to any normal organ * Inability to understand or give an informed consent * Patients who are seropositive for human immunodeficiency virus (HIV) * Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation * Circulating antibody against mouse immunoglobulin * DONOR: unrelated donors and donors mismatched for 1 or more HLA antigens * DONOR: donors who for psychologic, physiologic or medical reasons are unable to undergo filgrastim (G-CSF)- mobilized PBSC collection or marrow harvesting * DONOR: donors who are seropositive for HIV
References
Publications (0)
Data not yet available