Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or High-Risk Myelodysplastic Syndrome
TerminatedPhase 1Results postedLast updated 9 February 2023
What this trial tests
Phase 1 trial testing Allogeneic Bone Marrow Transplantation in Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome in 26 participants. Terminated before completion.
18 and older, any sex, with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome or Adult Acute Lymphoblastic Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Dose-limiting Toxicities (DLT) 30 Days After TransplantPrimary· Up to 30 days post-transplant
The criteria of Grade III/IV regimen-related toxicity (Bearman) or dose-limiting toxicity (DLT) are as follows:
Grade 1 Development of transient chemical abnormalities which are not of major clinical consequence and which reverse without requiring major medical interventions. In general, the intent of this toxicity scale is to observe transient target organ toxicity which is reversible.
Grade 2 Development of chemical or laboratory abnormalities that are persistent and which may represent target organ damage that may not be readily reversed. It is anticipated that at this dose of the drug, t
Participant Disease Response Within 90 Days After TransplantSecondary· Up to 90 days after transplant
The number of participants that are in complete remission or relapsed within 90 days after transplant
Complete Remission is defined as the complete resolution of all signs of leukemia for at least 90 days with all of the following:
1. Normal bone marrow with blasts \<5% with normal cellularity, normal megakarypoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis.
2. Normalization of blood counts (no blasts, platelets \> 100000/mm3, granulocytes \>1500/mm3)
3. No extramedullary disease
Relapse is measured as follows:
1. After CR: \>5% blasts in the bone marrow and/or p
Severity of Acute GVHD in Patients Who Completed the Study TreatmentSecondary· 100 days after transplant
The severity of acute GVHD is measured based on Graft vs Host Disease:
Grade I +1 to +2 skin rash No gut or liver involvement
Grade II +3 skin rash or
* 1 gastrointestinal involvement and/or +1 liver involvement
Grade III +2 to +4 gastrointestinal involvement and/or
* 2 to +4 liver involvement with or without a rash
Grade IV Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
Two-Year Disease-free Survival of Study Participants Who Completed the Study RegimenSecondary· 2 years post-transplant
Survival and complete resolution of all signs of leukemia 2 years after transplant with all of the following:
1, Normal bone marrow with blasts \<5% with normal cellularity, normal megakaryopoiesis, more than 15% erythropoiesis, and more than 25% granulocytopoiesis.
2\. Normalization of blood counts (no basts, platelets \>100,000/mm3, granulocytes \>1,500/mm3) 3. No extramedullary disease.
Time frame: Serious adverse events and Other (not including serious adverse events) were monitored and recorded from the time of first exposure to the investigational product (i.e. Iodine 131 + BC8 mAB) through day +100 post-transplant or through patient discharge from the Seattle Cancer Care Alliance (SCCA) system to the patient's primary physician. All-Cause Mortality was monitored/assessed for up to 2 years or through participant survival after completing the study regimen and transplant..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase I trial studies the side effects and best dose of iodine I 131monoclonal antibody BC8 when given together with fludarabine phosphate, cyclophosphamide, total-body irradiation, and donor bone marrow transplant, and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoblastic leukemia that has spread to nearby or other places in the body (advanced), or high-risk myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, and total-body irradiation before a donor bone marrow 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 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 make an immune response against the body's normal cells. Giving cyclophosphamide together with mycophenolate mofetil and tacrolimus after the transplant may stop this from happening. Giving a radiolabeled monoclonal antibody together with donor stem cell transplant, fludarabine phosphate, cyclophosphamide, mycophenolate mofetil, and tacrolimus may be an effective treatment for advanced acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 9 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00589316.