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
8 other identifiers
interventional
18
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
July 5, 2000
CompletedFirst Posted
Study publicly available on registry
July 9, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedAugust 30, 2017
August 1, 2017
6.3 years
July 5, 2000
August 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival (DFS)
Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Up to 6 years
Secondary Outcomes (3)
Overall survival (OS)
Up to 6 years
Relapse of AML patients
Up to 6 years
Transplant-related mortality
Up to 6 years
Study Arms (1)
Treatment (radiolabeled BC8, chemotherapy, PBSCT)
EXPERIMENTALRADIOLABELED 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.
Interventions
Given IV
Given PO
Given IV
Undergo allogeneic PBSC or bone marrow transplant
Undergo allogeneic PBSC or bone marrow transplant
Undergo allogeneic PBSC or bone marrow transplant
Given IV or PO
Given IV
Correlative studies
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Pacific Northwest National Laboratory
Richland, Washington, 99352, United States
VA Puget Sound Health Care System
Seattle, Washington, 98101, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johnnie Orozco
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2000
First Posted
July 9, 2003
Study Start
October 1, 1999
Primary Completion
January 1, 2006
Last Updated
August 30, 2017
Record last verified: 2017-08