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NCT01588951 · REGISTRY CONDITION SEARCH

Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2, PHASE3
Status at capture
TERMINATED
Registry last update
2018-08-14

The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Relapse Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Able to give informed consent 3. New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2 Exclusion criteria: 1. Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy 2. Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up 3. Pregnancy: Women of childbearing potential who are β- HCG+
healthy Volunteers
false
maximum Age
100 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Without LSC, standard cytarabine consolidation
    intervention Names
    1. Drug: Cytarabine consolidation
    label
    No Leukemia Stem Cells - Consolidation
    type
    EXPERIMENTAL
  2. description
    LSC present, randomized to cytarabine consolidation
    intervention Names
    1. Drug: Cytarabine consolidation
    label
    Leukemia Stem Cells - Consolidation
    type
    EXPERIMENTAL
  3. description
    LSC present, randomized to allogeneic transplant
    intervention Names
    1. Drug: Allogeneic transplant
    label
    Leukemia Stem Cells - Transplant
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Leukemia Stem Cells - Consolidation
    2. No Leukemia Stem Cells - Consolidation
    description
    Cytarabine-based consolidation per institutional standards.
    name
    Cytarabine consolidation
    other Names
    1. HiDAC
    type
    DRUG
  2. arm Group Labels
    1. Leukemia Stem Cells - Transplant
    description
    Allogeneic stem cell transplant per institutional standards.
    name
    Allogeneic transplant
    other Names
    1. Bone marrow transplant
    2. Stem cell transplant
    3. Hematopoietic stem cell transplant
    4. BMT
    5. HSCT
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
10
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of participants alive and without relapsed disease at two years.
    measure
    Relapse Free Survival
    time Frame
    2 years
Full study description
brief Summary
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-6ba7242f5d023f71d377
      requested nct id
      NCT01588951
      primary nct id
      NCT01588951
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      payload sha256
      8afdf6b389ea600ae56f259e455ec858ba5a8da5f2bed83ecfac807142d76709
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-6ba7242f5d023f71d377
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01588951
      occurrences
      1. context exact
        NCT01588951
        end
        11
        exact text
        NCT01588951
        start
        0
      offset unit
      unicode_code_points
      query cond
      Acute Undifferentiated Leukemia
      query disease state id
      ds-acute-undifferentiated-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-acute-undifferentiated-leukemia-000.json
      source file sha256
      a6089e8b15d43633ec778b2a5c464ada1207289beea2ae90de3e4bbe04b32186
      source json pointer
      /studies/16/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      afcb36e96907f5e41a2e255aec4e5df962ce2aac2b317f8149dc15f32ce5e8c4

    Preserved source evidence · Not medical advice