Extended Analysis for Leukemia/Lymphoma Treatment

• Status: Completed
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna

Criteria

Inclusion Criteria:

1. There are no further standard treatments available for the patient;

2. The patient has undergone at least two lines of previous therapy;

3. Cancer cell-containing biopsies are obtainable;

4. Informed consent from the patient was given;

5. candidate treatments identified by ngFDS are clinically available and considered safe given the patient health state.

Exclusion Criteria:

1. Presence of further treatment options, as defined by NCCN guidelines or Austrian guidelines representing a possible further treatment-related response by conventional therapies according to generally accepted medical evidence.

2. No fresh and viable tumor material available.

3. Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE v4.0) Grade 2 or higher from previous anti-cancer therapy, except alopecia.

4. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.

5. A history of known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.

6. A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.

7. History of other malignancy. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

8. Uncontrolled medical conditions (i.e, diabetes mellitus, hypertension, etc), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.

9. Pregnant or lactating females.

10. History of alcohol or drug abuse within 6 months prior to screening.

11. No informed consent available.

12. Exclusion criteria effective for respective treatment agents.