Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia
NCT03515707 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2021-02-01
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.
Conditions
- Acute Myeloid Leukemia
- Minimal Residual Disease Negativity
Interventions
- PROCEDURE
-
Autologous Hematopoietic Stem Cell Transplantation
Undergo ASCT
- DRUG
-
Busulfan
Given IV or oral
- DRUG
-
Etoposide
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Leona A. Holmberg · Fred Hutch/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-10
- Primary Completion
- 2022-04-15
- Completion
- 2022-07-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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