Clinical trial · Observational
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies
Comprehensive Genomic Profiling and Next Generation Functional Drug Screening for Patients With Aggressive Haematological Malignancies: Next Generation Personal Hematology
NCT04470947CI-TRIAL-00075346EXALT-2unknownClinicalTrials.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)
EXALT-2 is a prospective, randomized, three arm study for treatment decision guided either by either comprehensive genomic profiling, next generation drug screening or physician's choice
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Refractory Leukemia | Leukemia | CURATED_BROADER | 0.78 |
| Refractory Lymphoma | Lymphoma | CURATED_BROADER | 0.78 |
| Refractory T-Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive genomic profiling | Diagnostic Test | — | UNRESOLVED |
| Next generation functional drug screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Next generation functional drug screening
- interventionNames
- Diagnostic Test: Next generation functional drug screening
- Diagnostic Test: Comprehensive genomic profiling
- label
- Comprehensive genomic profiling
- interventionNames
- Diagnostic Test: Next generation functional drug screening
- Diagnostic Test: Comprehensive genomic profiling
- label
- Physician's choice
- interventionNames
- Diagnostic Test: Next generation functional drug screening
- Diagnostic Test: Comprehensive genomic profiling
Primary outcomes (1)
- measure
- Percentage of patients with a ratio ≥1.3 of progression free survival (PFS) compared to most recent treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient is suffering from aggressive haematological disease AND has undergone at least two lines of previous therapies AND/OR has undergone at least one previous therapy and no standard treatment is available in the specific disease setting and disease specific guidelines recommend treatment in studies. * duration of last response is less than 6 months defined as first day of last treatment to date of relapse, the response duration has to be available with dates (dd/mm/yyyy) for initiation of and relapse to previous treatment. * best response to previous treatment has to be available. * The patient is able to give written informed consent and wishes to undergo further therapy * further therapy is medically feasible * tumor cell-containing samples can be obtained Exclusion Criteria: * current participation in another experimental clinical trial * performance status does not allow participation (ECOG ˃ 1) * pregnancy, tested at screening * patient suffers from classical or nodular, lymphocyte predominant Hodgkins lymphoma. * other malignoma, diagnosed \<1a before inclusion (except localized squamous cell carcinoma of the skin, surgically curable melanoma of the skin, basal cell carcinoma of the skin)
References
Publications (1)
- BACKGROUNDSnijder B, Vladimer GI, Krall N, Miura K, Schmolke AS, Kornauth C, Lopez de la Fuente O, Choi HS, van der Kouwe E, Gultekin S, Kazianka L, Bigenzahn JW, Hoermann G, Prutsch N, Merkel O, Ringler A, Sabler M, Jeryczynski G, Mayerhoefer ME, Simonitsch-Klupp I, Ocko K, Felberbauer F, Mullauer L, Prager GW, Korkmaz B, Kenner L, Sperr WR, Kralovics R, Gisslinger H, Valent P, Kubicek S, Jager U, Staber PB, Superti-Furga G. Image-based ex-vivo drug screening for patients with aggressive haematological malignancies: interim results from a single-arm, open-label, pilot study. Lancet Haematol. 2017 Dec;4(12):e595-e606. doi: 10.1016/S2352-3026(17)30208-9. Epub 2017 Nov 15. PMID 29153976