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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03515707
Other study ID # 9784
Secondary ID NCI-2017-0206997
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 10, 2018
Est. completion date July 30, 2022

Study information

Verified date January 2021
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial studies how well autologous stem cell transplant works in treating patients with favorable or intermediate risk, minimal residual disease (MRD)-negative, acute myeloid leukemia. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body. After treatment, stem cells are collected from the patient's blood and stored. Higher dose chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.


Description:

PRIMARY OBJECTIVES: I. Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant. SECONDARY OBJECTIVES: I. Estimate the probability of transplant-related mortality (TRM) at 100 days following autologous stem cell transplant (ASCT). II. Estimate probabilities of overall and disease-free survival. III. Assess if biological and molecular correlative studies can predict better outcome. OUTLINE: Patients receive targeted busulfan intravenously (IV) or oral (PO) every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0. After completion of study treatment, patients are followed up yearly for 2 years.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 30, 2022
Est. primary completion date April 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: - AML favorable or intermediate ELN risk - Achieved true 1st complete response (CR) (absolute neutrophil count [ANC] and platelet count > 1,000/ul and 100,000/ul respectively) after first cycle of induction therapy, with no minimal residual disease (MRD) - No measurable residual disease (MRD) as assessed by flow cytometry after initial induction therapy - Performance score Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2 - Creatinine < 2.0 mg/dl and calculated by Cockcroft-Gault (CG) formula or 24 hour measured creatinine clearance (CRCL) > 50 - Not pregnant - Received 1-2 courses of post remission "consolidation" therapy prior to mobilization PBSC - No MRD by flow, cytogenetics, fluorescence in situ hybridization (FISH) and molecular testing prior to collection of autologous PBSC collection - Plan is to collect at least 3 x 10^6 CD34+ PBSC/kg cryopreserved; preference is 4-5 X 10^6 CD34 cells/kg Exclusion Criteria: - Life expectancy is severely limited by diseases other than AML - Total bilirubin > 2.0 mg/dl or serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) > 2.5 x upper limit of normal (ULN) - History of Gilbert's disease - Uncontrolled arrhythmias, left ventricular ejection fraction (LVEF) < 50% or corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 50% - Significant active infection that precludes transplant - Hepatitis B or C viremia at time of ASCT - History of central nervous system (CNS) involvement with AML

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Autologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
Drug:
Busulfan
Given IV or oral
Etoposide
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Fred Hutch/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relapse Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines. Assessed up to 2 years post autologous stem cell transplant (ASCT)
Primary Treatment related mortality Number of deaths without a prior relapse (unrelated to disease) From first dose of study therapy to day +100
Secondary Disease-free survival Proportion of patients living without relapse Assessed up to 4 years post-ASCT
Secondary Overall survival Proportion of patients living with or without relapse Assessed up to 4 years post-ASCT
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