Acute Myeloid LeukemiaPhase 2NCT03515707
Stem Cell Transplant to Treat Patients With Favorable or Intermediate Risk Minimal Residual Disease Negative Acute Myeloid Leukemia
A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Busulfan and Etoposide in people with Acute Myeloid Leukemia and Minimal Residual Disease Negativity, run by Fred Hutchinson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Acute Myeloid Leukemia, Minimal Residual Disease Negativity
- What is being tested?
- Autologous Hematopoietic Stem Cell Transplantation, Busulfan and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 30 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant.
SECONDARY OBJECTIVES:
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplantation
Undergo ASCT
BusulfanDrug
Also called 1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum
Given IV or oral
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Autologous Hematopoietic Stem Cell Transplantation; Drug: Busulfan; Drug: Etoposide; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Proportion of patients who relapse, as defined by 2017 National Comprehensive Cancer Network (NCCN ) Acute Myeloid Leukemia (AML) guidelines.
Measured: Assessed up to 2 years post autologous stem cell transplant (ASCT)
Treatment related mortality
Number of deaths without a prior relapse (unrelated to disease)
Measured: From first dose of study therapy to day +100
Secondary outcomes (2)
Disease-free survival
Proportion of patients living without relapse
Measured: Assessed up to 4 years post-ASCT
Overall survival
Proportion of patients living with or without relapse
Measured: Assessed up to 4 years post-ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start10 Jul 2018
- Primary completion15 Apr 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Why it stopped: PI recommended closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leona A. Holmberg, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515707
- Sponsor's protocol ID
- 9784
- Other IDs
- NCI-2017-02069, 9784, P30CA015704, RG9217025
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2018
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transplant as Treatment for Favorable or Intermediate Risk MRD-Negative AML Patients After Initial Induction Therapy
- ClinicalTrials.gov ID
- NCT03515707
- Acronym / sponsor ID
- 9784
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI recommended closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess the estimated probability of relapse at 2 years after autologous peripheral blood stem cell (PBSC) transplant.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (busulfan, etoposide, ASCT) | Experimental | Procedure: Autologous Hematopoietic Stem Cell Transplantation, Drug: Busulfan, Drug: Etoposide, Other: Laboratory Biomarker AnalysisPatients 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Hematopoietic Stem Cell TransplantationAlso: Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell TransplantationUndergo ASCT | Procedure or surgery | Treatment (busulfan, etoposide, ASCT) |
| BusulfanAlso: 1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, BusulfanumGiven IV or oral | Drug | Treatment (busulfan, etoposide, ASCT) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV | Drug | Treatment (busulfan, etoposide, ASCT) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (busulfan, etoposide, ASCT) |
Primary outcome
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.
Treatment related mortality
Time frame: From first dose of study therapy to day +100
Number of deaths without a prior relapse (unrelated to disease)
2 secondary outcomes
Disease-free survival
Time frame: Assessed up to 4 years post-ASCT
Overall survival
Time frame: Assessed up to 4 years post-ASCT
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leona A. Holmberg principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Hematopoietic Stem Cell Transplantation, Busulfan and Etoposide in people with Acute Myeloid Leukemia and Minimal Residual Disease Negativity, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: Assessed up to 2 years post autologous stem cell transplant (ASCT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.