Leukemia Stem Cell Detection in Acute Myeloid Leukemia

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-10-05

Brief Summary

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Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following induction chemotherapy. However, a large majority subsequently relapse and succumb to the disease. Currently, cytogenetics and molecular aberrations are the best prognostic indicators; however, these factors cannot prognosticate accurately for individual patients. Overall, the majority of patients with favorable or intermediate-risk AML will experience relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably translate into cure. This study is undertaken to determine whether the presence of LSCs has prognostic value as well as to determine whether the presence of LSCs has predictive value. This study has an observational component, whereby we intent evaluate whether the presence or absence of LSCs is prognostic. This study also has an interventional component in which it uses LSC status to determine whether favorable and intermediate risk AML patients in CR receive consolidation with chemotherapy or allogeneic HCT.

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Detailed Description

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Conditions

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Acute Myeloid Leukemia (AML)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evaluable Cohort - Transplant Arm

Other - Standard of Care Consolidation (HCT)

Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:

1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)
2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)
3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT

Group Type OTHER

Allogeneic HCT

Intervention Type PROCEDURE

Allogeneic HCT

Evaluable Cohort - Consolidation Chemo Arm

Other - Standard of Care Consolidation (cytarabine-based chemo)

Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements:

1. Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria)
2. Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0)
3. Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT)

Group Type OTHER

Consolidation chemotherapy

Intervention Type DRUG

Cytarabine-based consolidation chemotherapy

Observational Cohort 1

Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1.

Group Type NO_INTERVENTION

No interventions assigned to this group

Observational Cohort 2

Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria:

* Lack the immunophenotype of interest,
* Cytarabine based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit or refusal)\] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT)
* HMA-based induction subjects: Are not candidates for \[as determined by the investigator (e.g. unfit, lack of donor, refusal)\] and do not receive HCT

Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy.

HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Allogeneic HCT

Intervention Type PROCEDURE

Consolidation chemotherapy

Cytarabine-based consolidation chemotherapy

Intervention Type DRUG

Other Intervention Names

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transplant, allo HCT, PBSCT, SCT, BMT cytarabine, HiDAc, high dose cytarabine

Eligibility Criteria

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Inclusion Criteria

1. Must have previously signed the specimen procurement protocol consent associated with the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML therapy.
2. Age 18 years and older
3. New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and reviewed by an institutional hematopathologist
4. Completion of induction therapy, as defined by the Investigator and post-induction bone marrow biopsy.

Exclusion Criteria

1. Any debilitating medical or psychiatric illness that would preclude ability to follow study procedures.
2. Indeterminate leukemia stem cell assay results at diagnosis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No