Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Richland, Washington 99352


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

1470.00


NCT ID:

NCT00005940


Secondary ID:

NCI-2013-01361


Study Acronym:


Brief Title:

Radiolabeled BC8 Antibody, Busulfan, Cyclophosphamide Followed by Donor Stem Cell Transplant in Treating Patients With Acute Myelogenous Leukemia in F


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

16 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Fred Hutchinson Cancer Research Center


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Johnnie Orozco
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Dates

Start Date:October 1999
Primary Completion Date:January 2006
Primary Completion Type:Actual
Verification Date:August 2017
Last Changed Date:August 28, 2017
First Received Date:July 5, 2000

Study Outcomes

Outcome Type:Primary Outcome
Measure:Disease-free survival (DFS)
Time Frame:Up to 6 years
Safety Issues:False
Description:Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Outcome Type:Secondary Outcome
Measure:Overall survival (OS)
Time Frame:Up to 6 years
Safety Issues:False
Description:Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Outcome Type:Secondary Outcome
Measure:Relapse of AML patients
Time Frame:Up to 6 years
Safety Issues:False
Description:Summarized using appropriate time-to-event methods with estimates of the corresponding confidence intervals provided.
Outcome Type:Secondary Outcome
Measure:Transplant-related mortality
Time Frame:Up to 6 years
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Radiation
Name:iodine I 131 monoclonal antibody BC8
Description:Given IV
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:I 131 MOAB BC8
Intervention Type:Drug
Name:busulfan
Description:Given PO
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:BSF
Intervention Type:Drug
Name:cyclophosphamide
Description:Given IV
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:CPM
Intervention Type:Procedure
Name:allogeneic bone marrow transplantation
Description:Undergo allogeneic PBSC or bone marrow transplant
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:bone marrow therapy, allogeneic
Intervention Type:Procedure
Name:allogeneic hematopoietic stem cell transplantation
Description:Undergo allogeneic PBSC or bone marrow transplant
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Intervention Type:Procedure
Name:peripheral blood stem cell transplantation
Description:Undergo allogeneic PBSC or bone marrow transplant
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:PBPC transplantation
Intervention Type:Drug
Name:cyclosporine
Description:Given IV or PO
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:ciclosporin
Intervention Type:Drug
Name:methotrexate
Description:Given IV
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)
Other Name:amethopterin
Intervention Type:Other
Name:laboratory biomarker analysis
Description:Correlative studies
Arm Name:Treatment (radiolabeled BC8, chemotherapy, PBSCT)

Study Arms

Study Arm Type:Experimental
Arm Name: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Fred Hutchinson Cancer Research Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.