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

NCT02551718 | Completed Results

• 4 other identifiers: 9226NCI-2015-01299P30CA015704RG1015012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 (relapsed) or does not respond to treatment (refractory). 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.

Conditions

Recurrent Acute Leukemia of Ambiguous Lineage; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Acute Leukemia of Ambiguous Lineage

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients we Are Able to Test and Initiate Treatment Within a 21 Day Period

  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%.

  Up to 21 days

Secondary Outcomes (2)

• Rate of Complete Remission

  Up to 2 years

• Survival

  Up to 2 years

Study Arms (1)

Treatment (chemosensitivity testing, chemotherapy)

EXPERIMENTAL

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; Other: Cytology Specimen Collection Procedure; Genetic: Gene Expression Analysis; Genetic: Genetic Variation Analysis; Drug: In Vitro Sensitivity-Directed Chemotherapy

Interventions

Chemosensitivity Assay OTHER

Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations

Also known as: Chemosensitivity Testing

Treatment (chemosensitivity testing, chemotherapy)

Cytology Specimen Collection Procedure OTHER

Undergo blood or bone marrow collection

Also known as: Cytologic Sampling

Treatment (chemosensitivity testing, chemotherapy)

Gene Expression Analysis GENETIC

Analysis of leukemia cell genes to identify possible drug targets

Treatment (chemosensitivity testing, chemotherapy)

Genetic Variation Analysis GENETIC

Analysis of leukemia cell genes to identify possible drug targets

Also known as: Genetic Variation, GENVAR, mutation analysis

Treatment (chemosensitivity testing, chemotherapy)

In Vitro Sensitivity-Directed Chemotherapy DRUG

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

Treatment (chemosensitivity testing, chemotherapy)

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Interventions

Gene Expression Profiling; Genetic Variation

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Genetic Phenomena

Results Point of Contact

• Title: Dr. Percival
• Organization: University Of Washington

mperciva@seattlecca.org

206-606-1320

Study Officials

• Mary-Elizabeth Percival

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Hematology

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 16, 2015
• Study Start: September 11, 2015
• Primary Completion: June 19, 2020
• Study Completion: May 13, 2021
• Last Updated: June 30, 2022
• Results First Posted: June 30, 2021

Record last verified: 2022-06

Locations

US (1)