Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03515707|
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Minimal Residual Disease Negativity||Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Busulfan Drug: Etoposide Other: Laboratory Biomarker Analysis||Phase 2|
I. Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy|
|Actual Study Start Date :||July 10, 2018|
|Estimated Primary Completion Date :||April 15, 2022|
|Estimated Study Completion Date :||July 30, 2022|
Experimental: Treatment (busulfan, etoposide, ASCT)
Patients receive busulfan IV or oral every 6 hours on days -7 to -4 and etoposide IV on day -3. Patients then undergo autologous stem cell transplant on day 0.
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Given IV or oral
Other: Laboratory Biomarker Analysis
- Relapse [ Time Frame: Assessed up to 2 years post autologous stem cell transplant (ASCT) ]Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.
- Treatment related mortality [ Time Frame: From first dose of study therapy to day +100 ]Number of deaths without a prior relapse (unrelated to disease)
- Disease-free survival [ Time Frame: Assessed up to 4 years post-ASCT ]Proportion of patients living without relapse
- Overall survival [ Time Frame: Assessed up to 4 years post-ASCT ]Proportion of patients living with or without relapse
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515707
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Leona A. Holmberg 206-667-6447 email@example.com|
|Principal Investigator: Leona A. Holmberg|
|Principal Investigator:||Leona Holmberg||Fred Hutch/University of Washington Cancer Consortium|