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

NCT01872819 | Completed Results

• 3 other identifiers: 8003NCI-2013-01070P30CA015704
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Chronic Myelomonocytic Leukemia; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts

Outcome Measures

Primary Outcomes (1)

• 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

  Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.

  Up to 21 days

Secondary Outcomes (1)

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

  Baseline up to 2 years

Study Arms (1)

Treatment (chemotherapy, biological therapy)

EXPERIMENTAL

Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.

Other: antitumor drug screening assay; Drug: chemotherapy; Biological: biological therapy

Interventions

antitumor drug screening assay OTHER

Undergo high throughput drug sensitivity assay

Also known as: antitumor drug screening assays, drug screening assays, antitumor

Treatment (chemotherapy, biological therapy)

chemotherapy DRUG

Patients receive 1 of 160 possible interventions

Also known as: chemo

Treatment (chemotherapy, biological therapy)

biological therapy BIOLOGICAL

Patients receive 1 of 160 possible interventions

Treatment (chemotherapy, biological therapy)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Myelomonocytic, Chronic; Myeloproliferative Disorders; Anemia, Refractory, with Excess of Blasts

Interventions

Drug Screening Assays, Antitumor; Drug Therapy; Biological Therapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Marrow Diseases; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Evaluation, Preclinical; Evaluation Studies as Topic; Therapeutics

Results Point of Contact

• Title: Dr. Pamela Becker
• Organization: University of Washington

pbecker@u.washington.edu

206-288-7273

Study Officials

• Pamela Becker

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 7, 2013
• Study Start: August 2, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 17, 2014
• Last Updated: July 11, 2018
• Results First Posted: April 17, 2017

Record last verified: 2018-06

Locations

US (1)