Recruitment

Recruitment Status
Completed
Estimated Enrollment
15

Inclusion Criterias

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)
Willing to use contraception
Alkaline phosphatase =< 2.5 X ULN
...
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)
Willing to use contraception
Alkaline phosphatase =< 2.5 X ULN
Stable or improving on appropriate antimicrobial therapy for infection, without ongoing fever
Serum creatinine =< 2.0 mg/dL
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
Expectation that we can obtain about 100 million blasts from blood and/or marrow (for example, circulating blast count of 5,000 or greater)
Informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
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
Patients who have had a 1st remission for >= 1 year must have received cytotoxic chemotherapy as a salvage regimen

Exclusion Criterias

No other active cancer that requires systemic chemotherapy or radiation
Significant organ compromise that will increase risk of toxicity or mortality
Pregnancy or lactation
...
No other active cancer that requires systemic chemotherapy or radiation
Significant organ compromise that will increase risk of toxicity or mortality
Pregnancy or lactation
No other concomitant treatment for leukemia

Summary

Conditions
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • 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 Myelomonocytic Leukemia (M4)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Previously Treated Myelodysplastic Syndromes
  • Refractory Anemia With Excess Blasts
  • Adult Erythroleukemia (M6a)
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Pure Erythroid Leukemia (M6b)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Chronic Myelomonocytic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 compara...

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.

Inclusion Criterias

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)
Willing to use contraception
Alkaline phosphatase =< 2.5 X ULN
...
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)
Willing to use contraception
Alkaline phosphatase =< 2.5 X ULN
Stable or improving on appropriate antimicrobial therapy for infection, without ongoing fever
Serum creatinine =< 2.0 mg/dL
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
Expectation that we can obtain about 100 million blasts from blood and/or marrow (for example, circulating blast count of 5,000 or greater)
Informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
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
Patients who have had a 1st remission for >= 1 year must have received cytotoxic chemotherapy as a salvage regimen

Exclusion Criterias

No other active cancer that requires systemic chemotherapy or radiation
Significant organ compromise that will increase risk of toxicity or mortality
Pregnancy or lactation
...
No other active cancer that requires systemic chemotherapy or radiation
Significant organ compromise that will increase risk of toxicity or mortality
Pregnancy or lactation
No other concomitant treatment for leukemia

Locations

Seattle, Washington, 98109
Seattle, Washington, 98109

Tracking Information

NCT #
NCT01872819
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium