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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 firstname.lastname@example.org|
|Principal Investigator: Leona A. Holmberg|
|Principal Investigator:||Leona Holmberg||Fred Hutch/University of Washington Cancer Consortium|