N/A
N=14
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
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)
Bottom Line
View on ClinicalTrials.gov: NCT01872819 ↗Enrolled (actual)
14
Serious AEs
78.6%
Results posted
Apr 2017
Primary outcome: Primary: 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 — 5.1 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- antitumor drug screening assay (Other); chemotherapy (Drug); biological therapy (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.1 | — |
| SECONDARY Rate of Complete Response, Defined by Criteria of Cheson et al. |
1; 2; 6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01872819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.