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

NCT03515707 | Withdrawn Phase 2 FDA Drug

• 4 other identifiers: 9784NCI-2017-02069P30CA015704RG9217025
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia; Minimal Residual Disease Negativity

Outcome Measures

Primary Outcomes (2)

• 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)

• Treatment related mortality

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

  From first dose of study therapy to day +100

Secondary Outcomes (2)

• Disease-free survival

  Assessed up to 4 years post-ASCT

• Overall survival

  Assessed up to 4 years post-ASCT

Study Arms (1)

Treatment (busulfan, etoposide, ASCT)

EXPERIMENTAL

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; Drug: Busulfan; Drug: Etoposide; Other: Laboratory Biomarker Analysis

Interventions

Autologous Hematopoietic Stem Cell Transplantation PROCEDURE

Undergo ASCT

Also known as: Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation

Treatment (busulfan, etoposide, ASCT)

Busulfan DRUG

Given IV or oral

Also known as: 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

Treatment (busulfan, etoposide, ASCT)

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213

Treatment (busulfan, etoposide, ASCT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (busulfan, etoposide, ASCT)

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Busulfan; Etoposide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Leona A. Holmberg

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 3, 2018
• Study Start: July 10, 2018
• Primary Completion: April 15, 2022
• Study Completion: July 30, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)