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High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia

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ClinicalTrials.gov Identifier: NCT02551718
Recruitment Status : Recruiting
First Posted : September 16, 2015
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington

Study Description
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Brief Summary:
This pilot clinical trial studies the feasibility of choosing treatment based on a high throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients with acute leukemia that has returned after a period of improvement or does not respond to treatment. A high throughput screening assay tests many different drugs individually or in combination that kill leukemia cells in tiny chambers at the same time. High throughput drug sensitivity assay and mutation analysis may help guide the choice most effective for an individual's acute leukemia.

Condition or disease Intervention/treatment Phase
Acute Leukemia of Ambiguous Lineage Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Refractory Adult Acute Lymphoblastic Leukemia Refractory Childhood Acute Lymphoblastic Leukemia Other: Chemosensitivity Assay Other: Cytology Specimen Collection Procedure Genetic: Gene Expression Analysis Genetic: Genetic Variation Analysis Drug: In Vitro Sensitivity-Directed Chemotherapy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To test patient cells in a high throughput assay against individual drugs and drug combinations within 21 days to enable optimal choice of drug combinations for therapy.

II. To test gene expression that reveals activation of druggable pathways or mutations in genes that confer susceptibility to specific agents may also be considered in choice of treatment.

SECONDARY OBJECTIVES:

I. To evaluate the response to the chosen therapy.

OUTLINE:

Leukemia cells obtained from blood or bone marrow are analyzed for sensitivity to both individual drugs and drug combinations via high throughput chemotherapy sensitivity assay and next generation sequencing assays. Doctors will then recommend chemotherapy regimens based on the results.

After completion of the chemotherapy regimen, patients are followed up at 2-4 weeks for response, and then every 3 months for 2 years for duration of response and survival.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualized Treatment for Relapsed/Refractory Acute Leukemia Based on Chemosensitivity and Genomics/Gene Expression Data
Actual Study Start Date : September 11, 2015
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (chemosensitivity testing, chemotherapy)
Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.
 Other: Chemosensitivity Assay
Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations
Other Name: Chemosensitivity Testing

Other: Cytology Specimen Collection Procedure
Undergo blood or bone marrow collection
Other Name: Cytologic Sampling

Genetic: Gene Expression Analysis
Analysis of leukemia cell genes to identify possible drug targets

Genetic: Genetic Variation Analysis
Analysis of leukemia cell genes to identify possible drug targets
Other Names:
  • Genetic Variation
  • GENVAR
  • mutation analysis

Drug: In Vitro Sensitivity-Directed Chemotherapy

Receive personalized chemotherapy with one or more of the following drugs:

Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients we are able to test and initiate treatment within a 21 day period. [ Time Frame: Up to 21 days ]
    The study will be considered successful (feasibility demonstrated) if it is possible to choose and initiate a combination drug regimen within 21 days in 9 out of 15 patients. With that outcome, there would be 90% confidence that the true feasibility rate is at least 40%.


Secondary Outcome Measures :
  1. Rate of complete remission [ Time Frame: Up to 2 years ]
    Reports on each patient's course post stem cell transplant, if applicable, will be reviewed to determine response and duration of remission.

  2. Survival [ Time Frame: Up to 2 years ]
    Disease free and overall survival data will be assessed by contacting the referring MD or the patient every three months for the first two years.


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of acute leukemia by World Health Organization (WHO) criteria (e.g.-acute myeloid leukemia, acute lymphoblastic leukemia, acute leukemia of ambiguous origin)

  • Either:

    • Relapsed after or refractory to prior treatment with at least two regimens or lines of treatment
    • Prior failure of at least one regimen or line of treatment, with poor cytogenetic or other risk factors, and ineligible for other clinical trials
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
  • Expectation that we can obtain about 10 million blasts from blood and/or marrow (e.g., circulating blast count of 5,000 or greater or cellular marrow with greater than or equal to 20% blasts)
  • Bilirubin =< 1 .5 x upper limit of normal (ULN) 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 glutamate pyruvate transaminase (SPGT) (alanine aminotransferase [ALT]) =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
  • Alkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy
  • Serum creatinine =< 2.0 mg/dL
  • Informed consent
  • Willing to use contraception when appropriate
  • Expected survival is greater than 100 days

Exclusion Criteria:

  • No other active cancer that requires systemic chemotherapy or radiation
  • Active systemic fungal, bacterial, viral or other infection, unless disease is under treatment with antimicrobials and considered controlled in the opinion of the investigator
  • Significant organ compromise that will increase risk of toxicity or mortality
  • Pregnancy or lactation
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551718


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Pamela S. Becker    206-616-1589    pbecker@u.washington.edu   
Principal Investigator: Pamela S. Becker         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Pamela Becker Fred Hutch/University of Washington Cancer Consortium
More Information
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02551718    
Other Study ID Numbers: 9226
NCI-2015-01299 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9226 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Acute Disease
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes