NCT03515707

Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia

Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Myeloid Leukemia
• Minimal Residual Disease Negativity

Interventions

Type	Name	Description
PROCEDURE	Autologous Hematopoietic Stem Cell Transplantation	Undergo ASCT
DRUG	Busulfan	Given IV or oral
DRUG	Etoposide	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-07-10
• Primary completion: 2022-04-15
• Completion: 2022-07-30
• First posted: 2018-05-03
• Last updated: 2021-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study