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

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03515707
• Other study ID #: 9784
• Secondary ID: NCI-2017-0206997
• Status: Withdrawn
• Phase: Phase 2
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Minimal Residual Disease Negativity
• Neoplasm, Residual

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