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Extended Analysis for Leukemia/Lymphoma Treatment

NCT03096821 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 143

Last updated 2021-02-24

No results posted yet for this study

Summary

Patients with relapsed/ refractory acute leukemia and relapsed/ refractory aggressive lymphoma harboring an activating genetic alteration (gene mutation, gene fusion) or drug-able biomarker / activated signal transduction pathway and resistant to any approved treatment modality will be eligible for this study.

The investigators aim to combine DNA sequencing-based molecular profiling with an ex vivo high-throughput drug screening strategy. For the latter method, viable cells are obtained from the individual patient's lymphoma or leukemia in order to determine i)the expression of relevant therapeutic target molecules and ii)the ex vivo response of the patient's cancer cells to a panel of agents with anticancer activity. In addition, analysis of tumor stroma cells will provide information about the differential target expression and cellular sensitivity aiming at the evaluation of a therapeutic safety window. Thereby, biological material will have to be accessed within 4 weeks before onset of individualized treatment (real-time biopsy). Bioinformatic data-management based on a Bayesian statistical approach will support individualized treatment decisions in this controlled clinical approach.

Conditions

  • Relapsed Hematologic Malignancy

Interventions

DRUG

ngFDS selected treatment

Treatment based on next-generation functional drug screening (ngFDS). Treatment with commercially available treatments (per package insert instructions) selected by functional drug screening. For drug screening tumor cells from bone marrow aspirates, peripheral blood, pleural effusion, or excised lymph node samples are purified over Ficoll gradient (bone marrow, peripheral blood, pleural effusion) (GE healthcare) or homogenized and filtered (lymph tissue).

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Philipp B Staber, MD, PhD · Medical University of Vienna, Department of Medicine I, Division of Hematology and Hemostaseology

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03096821 on ClinicalTrials.gov