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NCT01872819 · REGISTRY CONDITION SEARCH

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

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

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-07-11

This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.

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

Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML

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outcome · POSTED

Rate of Complete Response, Defined by Criteria of Cheson et al.

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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: * Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria (except acute promyelocytic leukemia), acute leukemias of ambiguous lineage by WHO criteria, or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO classification who have failed 2 inductions at initial diagnosis or failed \>= 2 salvage regimens for relapsed acute myeloid leukemia (AML) * Patients who have had a 1st remission for \>= 1 year must have received cytotoxic chemotherapy as a salvage regimen * Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3 * Expectation that we can obtain about 100 million blasts from blood and/or marrow (for example, circulating blast count of 5,000 or greater) * Bilirubin =\< 1.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum pyruvate glutamate transaminase (SPGT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN, unless elevation in thought to be due to hepatic infiltration by the hematologic malignancy * Alkaline phosphatase =\< 2.5 X ULN * Serum creatinine =\< 2.0 mg/dL * Stable or improving on appropriate antimicrobial therapy for infection, without ongoing fever * Informed consent * Willing to use contraception Exclusion Criteria: * No other concomitant treatment for leukemia * No other active cancer that requires systemic chemotherapy or radiation * Significant organ compromise that will increase risk of toxicity or mortality * Pregnancy or lactation
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
    intervention Names
    1. Other: antitumor drug screening assay
    2. Drug: chemotherapy
    3. Biological: biological therapy
    label
    Treatment (chemotherapy, biological therapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Undergo high throughput drug sensitivity assay
    name
    antitumor drug screening assay
    other Names
    1. antitumor drug screening assays
    2. drug screening assays, antitumor
    type
    OTHER
  2. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Patients receive 1 of 160 possible interventions
    name
    chemotherapy
    other Names
    1. chemo
    type
    DRUG
  3. arm Group Labels
    1. Treatment (chemotherapy, biological therapy)
    description
    Patients receive 1 of 160 possible interventions
    name
    biological therapy
    type
    BIOLOGICAL
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.
    measure
    Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML
    time Frame
    Up to 21 days
secondary Outcomes
  1. description
    Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction). Cheson et al. defines a CR as: Bone Marrow blasts \<5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 10\^9/L, and platelet count \>100 x 10\^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (\<1.0 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L).
    measure
    Rate of Complete Response, Defined by Criteria of Cheson et al.
    time Frame
    Baseline up to 2 years
Full study description
brief Summary
This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.
detailed Description
PRIMARY OBJECTIVES: I. To obtain results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days. SECONDARY OBJECTIVES: I. To achieve a response (cytoreduction or at least partial response) greater that than expected for comparable refractory patient populations with other salvage regimens. OUTLINE: A patient receives a drug intervention based on the results of a high throughput sensitivity assay. This assay best matches a drug to the patient's disease.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      primary nct id
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
      nct-edge-4ebe2c6d5aba73a99582
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT01872819
        end
        11
        exact text
        NCT01872819
        start
        0
      offset unit
      unicode_code_points
      query cond
      Juvenile Myelomonocytic Leukemia
      query disease state id
      ds-juvenile-myelomonocytic-leukemia
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
      source file sha256
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      source json pointer
      /studies/52/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      17ca4be81ab07cd3109bfce2429aaa894210823afd1047ad69e9f35dccb78af0

    Preserved source evidence · Not medical advice