Immune System Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Hypersensitivity

Hematologic Neoplasms

Hematologic Diseases

drug sensitivity testing of primary patient derived cancer cells

ex-vivo drug response assay

Sascha Dietrich, MD

This observational study evaluates if drug response testing can be performed within 7 days and analyzes the value of ex-vivo drug screening for hematological malignancies as a biomarker to predict outcome, clinical course and response to treatment.

Targeted treatments have revolutionized care of individual diseases. While a new generation of targeted drugs is emerging in leukemia and lymphoma it remains clinical reality that most genetic information is not used for therapeutic stratification. This is in part based on the shortcomings of traditional biomarker discovery within clinical trials, where throughput is limited in both, drug number and sample size. If it were possible to map the variable pathway dependencies and drug sensitivity patterns in individual patients it is likely to become an asset to identify genotype-phenotype associations, understand the underlying complexities of molecular networks and further precision medicine stratification.

To link clinical outcome and ex-vivo drug response assays, the investigators systematically measure pathway sensitivity and resistance of primary tumor cells ex-vivo using a diverse compound library for individual patients in need of treatment. By systematically analyzing ex-vivo drug response patterns, tumors should be functionally grouped, by response phenotype. While for the purpose of this study selection of a specific treatment will not be based on ex-vivo drug response assays, clinical response- and follow-up data of patients will be prospectively collected in parallel.

Blood samples, bonemarrow aspiration, tissue of lymphnodes

Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer

Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer (SMARTrial)

Patients' sample (blood, bonemarrow aspirate, tissue of lymphnode) will collected on day 0. Ex-vivo drug sensitivity testing will be performed.

Ex-vivo drug sensitivity categorizes drugs as sensitive/not sensitive. Results will be compared with clinical outcome of patient (response vs. stable disease as defined in the clinical response definition by protocol

prediction of time to next treatment by a mathematical model based on ex-vivo drug response testing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer	NCT03488641	Hematologic Dis... Treatment	ex-vivo drug re...	18 Years -	German Cancer Research Center
Systematic and Mechanism-based Approach to Rational Treatment Trials of Blood Cancer	NCT03488641	Hematologic Dis... Treatment	ex-vivo drug re...	18 Years -	German Cancer Research Center

Spots Global Cancer Trial Database for genomic landscape