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

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ClinicalTrials.gov Identifier: NCT03515707
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Minimal Residual Disease Negativity Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Busulfan Drug: Etoposide Other: Laboratory Biomarker Analysis Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : July 30, 2022


Arm Intervention/treatment
Experimental: Treatment (busulfan, etoposide, ASCT)
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
Undergo ASCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • Autologous Stem Cell Transplantation

Drug: Busulfan
Given IV or oral
Other Names:
  • 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

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16-213
  • VP-16
  • VP-16-213

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Relapse [ Time Frame: Assessed up to 2 years post autologous stem cell transplant (ASCT) ]
    Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.

  2. Treatment related mortality [ Time Frame: From first dose of study therapy to day +100 ]
    Number of deaths without a prior relapse (unrelated to disease)


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: Assessed up to 4 years post-ASCT ]
    Proportion of patients living without relapse

  2. Overall survival [ Time Frame: Assessed up to 4 years post-ASCT ]
    Proportion of patients living with or without relapse



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515707


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Leona A. Holmberg    206-667-6447    emcdanie@fredhutch.org   
Principal Investigator: Leona A. Holmberg         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Leona Holmberg Fred Hutch/University of Washington Cancer Consortium

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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03515707     History of Changes
Other Study ID Numbers: 9784
NCI-2017-02069 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9784 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG9217025 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Etoposide
Etoposide phosphate
Busulfan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Alkylating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Myeloablative Agonists