Acute Myeloid LeukemiaPhase 2NCT02756962
Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance
A Phase 2 study testing Cytarabine, Allogeneic stem cell transplant and Bone marrow aspiration in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 3 sites in United States.
Trial summary
The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cytarabine, Allogeneic stem cell transplant and Bone marrow aspiration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jul 2016to 31 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Considered to be suitable intensive (cytotoxic) induction candidates.
- Has previously untreated, de novo, non-M3 AML with intermediate-risk disease (Intermediate-I or Intermediate-II) as defined by ELN criteria OR normal cytogenetics with mutated NPM1 without FLT3-ITD. Monoallelic CEBPA mutations are not considered favorable risk and are therefore eligible.
- Has undergone cytotoxic induction therapy
- In a morphologic complete remission with incomplete blood count recovery, or morphologic complete remission post-induction after no more than 2 induction cycles as defined by revised IWG criteria
- Patients at Washington University must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").This is not a requirement for secondary sites. However, secondary sites must provide informed consent forms that document that permission for whole genome, whole exome, and/or genome wide sequencing, and data sharing among institutions, was obtained. Because we will be also be sequencing non-diseased (normal) tissue, the informed consent forms must explicitly ask if patients wish to be informed, (or in the case of their death, their next-of-kin) if a deleterious mutation is identified in their non-diseased tissue, as this may be heritable.
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- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Able to understand and willing to sign an IRB approved written informed consent document.
- Willing to comply with the treatment assignment:
- Intent to proceed with HiDAC consolidation for LAM VAF <2.5%
- Intent to proceed with either HiDAC consolidation or allogeneic stem cell transplantation, at the discretion of the treating physician, for LAM ≥2.5%
Who cannot join
- Diagnosis acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA.
- Therapy-related AML (defined as occurrence of AML due to prior exposure to chemotherapy or radiation for malignancy).
- Secondary AML (defined as development of AML in patients with an antecedent hematological malignancy).
- Has a medical or psychosocial conditions that would prevent study compliance.
- Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B vaccine are eligible.
- History of allergic reaction to compounds of similar chemical or biologic composition to cytarabine.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 3 days of signing consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida
Gainesville, Florida, 32608
University of Rochester
Rochester, New York, 14642
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cytarabine, Allogeneic stem cell transplant, Bone marrow aspiration, Punch skin biopsy, ClinSeq
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
Also called Ara-C, Cytosar-U, Tarabine-PFS, AraC
Allogeneic stem cell transplantProcedure or surgery
Also called AlloSCT
Bone marrow aspirationProcedure or surgery
- Baseline
- Approximately 30 days after cytotoxic induction therapy
- End of treatment
Punch skin biopsyProcedure or surgery
- The first will be obtained with the initial blood and bone marrow collections, whenever possible.
- The second will be obtained at the time of re-biopsy to confirm remission.
ClinSeqDevice
Clinical Sequencing to determine clearance or persistence of leukemia-associate mutations performed at MGI CLIA lab
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: HiDAC | Experimental | * At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq
* Patients who have clearance of their leukemia-associated mutations, defined as a LAM VAF <2.5% will be assigned to the high-dose cytarabine consolidation (HiDAC) arm.
* HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, \& 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI.
* For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician. Receives: Drug: Cytarabine; Procedure: Bone marrow aspiration; Procedure: Punch skin biopsy; Device: ClinSeq |
| Cohort B: Investigator's choice (HiDAC, AlloSCT) | Experimental | * At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq
* Patients who have persistent leukemia-associated mutations, defined as a LAM VAF ≥2.5% will be assigned to the investigator's choice arm.
* Patients assigned to this arm may received either HiDAC or AlloSCT.
* HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, \& 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI.
* The source of stem cell product, donor selection, conditioning regimen, graft-versus-host-prophylaxis, and supportive care will be at the discretion of the treatment physician
* For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician. Receives: Drug: Cytarabine; Procedure: Allogeneic stem cell transplant; Procedure: Bone marrow aspiration; Procedure: Punch skin biopsy; Device: ClinSeq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse free survival of Cohort A compared to intermediate risk historical control group
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Secondary outcomes (13)
Overall survival (OS) of Cohort A compared intermediate risk historical control group
Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Relapse free survival (RFS) of Cohort B
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Overall survival (OS) of Cohort B
Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Compare relapse free survival of Cohort A to Cohort B
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Compare overall survival of Cohort A to Cohort B
Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Compare relapse free survival of Cohort A to Cohort B
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: 1 year
Compare overall survival of Cohort A to Cohort B
Overall survival is the time from enrollment on study until death from any cause.
Measured: 1 year
Relapse free survival of Cohort B patients who receive alloSCT
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Overall survival of Cohort B patients who receive alloSCT
Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Relapse free survival of Cohort B patients who do not receive alloSCT
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Overall survival of Cohort B patients who do not receive alloSCT
Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Relapse free survival of patients with a LAM VAF <1.0% treated in Cohort A compared to intermediate risk historical control group
- LAM VAF = Leukemia Associated Mutations variant allele frequency
- Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause.
- CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation.
- CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
Measured: Up to 5 years
Overall survival of patients with a LAM VAF <1.0% treated in Cohort A compared to intermediate risk historical control group
--LAM VAF = Leukemia Associated Mutations variant allele frequency
-Overall survival is the time from enrollment on study until death from any cause.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start6 Jul 2016
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society, American Society of Hematology
- Responsible party
- Sponsor
- Investigators
- Meagan Jacoby, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756962
- Sponsor's protocol ID
- 201606003
- Status last verified
- Oct 2026
- First submitted
- 27 Apr 2016
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jacoby MA, Spencer DH, Gao F, Uy GL, Burton T, Heath SE, Du F, O'Laughlin M, Fulton RS, Miller CA, Duncavage EJ, Schroeder MA, Ghobadi A, Pusic I, Stockerl-Goldstein KE, Kahl BS, Cashen AF, Christopher MJ, Singh N, Vij R, Crees ZD, Wartman LD, Day RB, Fehniger TA, Oetjen KA, Patel DA, Kim MY, Slade MJ, Ferraro F, Walter MJ, Abboud CN, Abboud R, Link DC, Al-Mansour ZA, Cogle CR, Huselton EJ, DiPersio JF, Westervelt P, Ley TJ. Consolidation Therapy Based on Mutation Clearance in Acute Myeloid Leukemia. NEJM Evid. 2026 Sep;5(9):EVIDoa2500352. doi: 10.1056/EVIDoa2500352. Epub 2026 Aug 25.
PubMed 42640163
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Risk Assessment of AML With a Precision Genomic Strategy to Assess Mutation Clearance
- ClinicalTrials.gov ID
- NCT02756962
- Acronym / sponsor ID
- 201606003
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Leukemia and Lymphoma Society, American Society of Hematology
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
The investigators will prospectively determine whether the relapse-free and overall survival in patients who have cleared their leukemia-associated mutations treated with standard consolidation chemotherapy is superior to what is expected based on historical controls. The investigators will also prospectively determine the relapse-free and overall survival of patients who have not cleared their mutations. Because the relapse rate of patients with persistent mutations is expected to be high, treatment with either standard of care consolidation therapy alone or alloSCT will be permitted, at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: HiDAC | Experimental | Drug: Cytarabine, Procedure: Bone marrow aspiration, Procedure: Punch skin biopsy, Device: ClinSeq* At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq * Patients who have clearance of their leukemia-associated mutations, defined as a LAM VAF <2.5% will be assigned to the high-dose cytarabine consolidation (HiDAC) arm. * HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, \& 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI. * For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician. |
| Cohort B: Investigator's choice (HiDAC, AlloSCT) | Experimental | Drug: Cytarabine, Procedure: Allogeneic stem cell transplant, Procedure: Bone marrow aspiration, Procedure: Punch skin biopsy, Device: ClinSeq* At the time of diagnostic bone marrow biopsy, samples will be clinically sequenced via ClinSeq * Patients who have persistent leukemia-associated mutations, defined as a LAM VAF ≥2.5% will be assigned to the investigator's choice arm. * Patients assigned to this arm may received either HiDAC or AlloSCT. * HiDAC = Standard regimen of cytarabine 1.5 g/m^2 or 3 g/m^2 over 2-3 hours twice a day on Days 1, 3, \& 5 of each 28 day cycle for 3-4 cycles. Can be replaced by Onureg with permission from PI. * The source of stem cell product, donor selection, conditioning regimen, graft-versus-host-prophylaxis, and supportive care will be at the discretion of the treatment physician * For patients with the FLT3-ITD or a FLT3-TKD mutation, therapy with the FDA-approved FLT3 inhibitor midostaurin is permitted at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18-60 years.
- Considered to be suitable intensive (cytotoxic) induction candidates.
- Has previously untreated, de novo, non-M3 AML with intermediate-risk disease (Intermediate-I or Intermediate-II) as defined by ELN criteria OR normal cytogenetics with mutated NPM1 without FLT3-ITD. Monoallelic CEBPA mutations are not considered favorable risk and are therefore eligible.
- Has undergone cytotoxic induction therapy
- In a morphologic complete remission with incomplete blood count recovery, or morphologic complete remission post-induction after no more than 2 induction cycles as defined by revised IWG criteria
Key exclusion criteria (7 listed)
- Diagnosis acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); PML-RARA.
- Therapy-related AML (defined as occurrence of AML due to prior exposure to chemotherapy or radiation for malignancy).
- Secondary AML (defined as development of AML in patients with an antecedent hematological malignancy).
- Has a medical or psychosocial conditions that would prevent study compliance.
- Known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B vaccine are eligible.
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 |
|---|---|---|
| CytarabineAlso: Ara-C, Cytosar-U, Tarabine-PFS, AraC | Drug | Cohort A: HiDAC, Cohort B: Investigator's choice (HiDAC, AlloSCT) |
| Allogeneic stem cell transplantAlso: AlloSCT | Procedure or surgery | Cohort B: Investigator's choice (HiDAC, AlloSCT) |
| Bone marrow aspiration* Baseline * Approximately 30 days after cytotoxic induction therapy * End of treatment | Procedure or surgery | Cohort A: HiDAC, Cohort B: Investigator's choice (HiDAC, AlloSCT) |
| Punch skin biopsy* The first will be obtained with the initial blood and bone marrow collections, whenever possible. * The second will be obtained at the time of re-biopsy to confirm remission. | Procedure or surgery | Cohort A: HiDAC, Cohort B: Investigator's choice (HiDAC, AlloSCT) |
| ClinSeqClinical Sequencing to determine clearance or persistence of leukemia-associate mutations performed at MGI CLIA lab | Device | Cohort A: HiDAC, Cohort B: Investigator's choice (HiDAC, AlloSCT) |
Primary outcome
Relapse free survival of Cohort A compared to intermediate risk historical control group
Time frame: Up to 5 years
* Relapse-free survival is the time from study enrollment (morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) is required) until documented disease relapse, or death from any cause. * CR=Defined as morphologic leukemia-free state, defined as less than 5% blasts in aspirate with marrow spicules and a count of ≥200 nucleated cells and no blasts with Auer rods or any persistence of extramedullary disease. In addition, ANC >1000/μl and platelet count of ≥100,000/μl. Patient must be independent of transfusions. No duration requirement for this designation. * CRi=Defined as morphologic complete recovery with the exception of neutropenia <1000/μl or thrombocytopenia <100,000/μl.
13 secondary outcomes
Overall survival (OS) of Cohort A compared intermediate risk historical control group
Time frame: Up to 5 years
Relapse free survival (RFS) of Cohort B
Time frame: Up to 5 years
Overall survival (OS) of Cohort B
Time frame: Up to 5 years
Compare relapse free survival of Cohort A to Cohort B
Time frame: Up to 5 years
Compare overall survival of Cohort A to Cohort B
Time frame: Up to 5 years
Compare relapse free survival of Cohort A to Cohort B
Time frame: 1 year
Compare overall survival of Cohort A to Cohort B
Time frame: 1 year
Relapse free survival of Cohort B patients who receive alloSCT
Time frame: Up to 5 years
Overall survival of Cohort B patients who receive alloSCT
Time frame: Up to 5 years
Relapse free survival of Cohort B patients who do not receive alloSCT
Time frame: Up to 5 years
Overall survival of Cohort B patients who do not receive alloSCT
Time frame: Up to 5 years
Relapse free survival of patients with a LAM VAF <1.0% treated in Cohort A compared to intermediate risk historical control group
Time frame: Up to 5 years
Overall survival of patients with a LAM VAF <1.0% treated in Cohort A compared to intermediate risk historical control group
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Derived from this study: PubMed 42640163Jacoby MA, Spencer DH, Gao F, Uy GL, Burton T, Heath SE, Du F, O'Laughlin M, Fulton RS, Miller CA, Duncavage EJ, Schroeder MA, Ghobadi A, Pusic I, Stockerl-Goldstein KE, Kahl BS, Cashen AF, Christopher MJ, Singh N, Vij R, Crees ZD, Wartman LD, Day RB, Fehniger TA, Oetjen KA, Patel DA, Kim MY, Slade MJ, Ferraro F, Walter MJ, Abboud CN, Abboud R, Link DC, Al-Mansour ZA, Cogle CR, Huselton EJ, DiPersio JF, Westervelt P, Ley TJ. Consolidation Therapy Based on Mutation Clearance in Acute Myeloid Leukemia. NEJM Evid. 2026 Sep;5(9):EVIDoa2500352. doi: 10.1056/EVIDoa2500352. Epub 2026 Aug 25.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Meagan Jacoby, M.D., Ph.D. principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytarabine, Allogeneic stem cell transplant and Bone marrow aspiration in people with Acute Myeloid Leukemia, run by Washington University School of Medicine at 3 sites 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 11 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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 free survival of Cohort A compared to intermediate risk historical control group (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756962, which also lists 1 linked publication.
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 29 Oct 2026.