Clinical trial · Interventional
High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia
Individualized Treatment for Relapsed/Refractory Acute Leukemia Based on Chemosensitivity and Genomics/Gene Expression Data
NCT02551718CI-TRIAL-00059381completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Acute Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
| Recurrent Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Refractory Acute Leukemia of Ambiguous Lineage | Acute Leukemia of Ambiguous Lineage | CURATED_BROADER | 0.80 |
| Refractory Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemosensitivity Assay | Other | — | UNRESOLVED |
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Gene Expression Analysis | Genetic | — | UNRESOLVED |
| Genetic Variation Analysis | Genetic | — | UNRESOLVED |
| In Vitro Sensitivity-Directed Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemosensitivity testing, chemotherapy)
- description
- Leukemia cells purified from blood or bone marrow samples are analyzed for sensitivity to individual drugs and drug combination and by next generation sequencing.
- interventionNames
- Other: Chemosensitivity Assay
- Other: Cytology Specimen Collection Procedure
- Genetic: Gene Expression Analysis
- Genetic: Genetic Variation Analysis
- Drug: In Vitro Sensitivity-Directed Chemotherapy
Primary outcomes (1)
- measure
- Percentage of Patients we Are Able to Test and Initiate Treatment Within a 21 Day Period
- timeFrame
- Up to 21 days
- description
- 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 outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.