Clinical Trials /

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

NCT03515707

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 9784
  • SECONDARY ID: NCI-2017-02069
  • SECONDARY ID: 9784
  • SECONDARY ID: P30CA015704
  • NCT ID: NCT03515707

Conditions

  • Acute Myeloid Leukemia
  • Minimal Residual Disease Negativity

Interventions

DrugSynonymsArms
Busulfan1, 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-19508Treatment (busulfan, etoposide, ASCT)
EtoposideDemethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213Treatment (busulfan, etoposide, ASCT)

Purpose

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) (ASCT) transplant.

      SECONDARY OBJECTIVES:

      I. Estimate the probability of transplant-related mortality (TRM) at 100 days following 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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (busulfan, etoposide, ASCT)ExperimentalPatients 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.
  • Busulfan
  • Etoposide

Eligibility Criteria

        Inclusion Criteria:

          -  AML favorable or intermediate European LeukemiaNet (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, cytogenics, 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
      
Maximum Eligible Age:69 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse
Time Frame:Assessed up to 2 years post autologous stem cell transplant (ASCT)
Safety Issue:
Description:Proportion of patients who relapse, as defined by 2017 NCCN AML guidelines

Secondary Outcome Measures

Measure:Disease-free survival
Time Frame:Assessed up to 4 years post-ASCT
Safety Issue:
Description:Proportion of patients living without relapse
Measure:Overall survival
Time Frame:Assessed up to 4 years post-ASCT
Safety Issue:
Description:Proportion of patients living with or without relapse

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Fred Hutchinson Cancer Research Center

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