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

Primary Purpose

Acute Myeloid Leukemia, Minimal Residual Disease Negativity

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Autologous Hematopoietic Stem Cell Transplantation

Busulfan

Etoposide

Laboratory Biomarker Analysis

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (busulfan, etoposide, ASCT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Relapse

Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.

Treatment related mortality

Number of deaths without a prior relapse (unrelated to disease)

Secondary Outcome Measures

Disease-free survival

Proportion of patients living without relapse

Overall survival

Proportion of patients living with or without relapse

Full Information

NCT ID

NCT03515707

First Posted

April 23, 2018

Last Updated

January 27, 2021

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03515707

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Withdrawn

Why Stopped

PI recommended closure

Study Start Date

July 10, 2018 (Actual)

Primary Completion Date

April 15, 2022 (Anticipated)

Study Completion Date

July 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Minimal Residual Disease Negativity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (busulfan, etoposide, ASCT)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Autologous Hematopoietic Stem Cell Transplantation

Other Intervention Name(s)

Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation

Intervention Description

Undergo ASCT

Intervention Type

Drug

Intervention Name(s)

Busulfan

Other Intervention Name(s)

1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508

Intervention Description

Given IV or oral

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Relapse

Description

Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.

Time Frame

Assessed up to 2 years post autologous stem cell transplant (ASCT)

Title

Treatment related mortality

Description

Number of deaths without a prior relapse (unrelated to disease)

Time Frame

From first dose of study therapy to day +100

Secondary Outcome Measure Information:

Title

Disease-free survival

Description

Proportion of patients living without relapse

Time Frame

Assessed up to 4 years post-ASCT

Title

Overall survival

Description

Proportion of patients living with or without relapse

Time Frame

Assessed up to 4 years post-ASCT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

69 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leona A. Holmberg

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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