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MRD-driven treatment with venetoclax-R2 in mantle cell lymphoma : the Nordic Lymphoma Group MCL7 VALERIA trial

Jerkeman, Mats (författare)
Lund University,Lunds universitet,Medicinsk onkologi,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Lymfom - Klinisk forskning,Forskargrupper vid Lunds universitet,LUCC: Lunds universitets cancercentrum,Övriga starka forskningsmiljöer,Onkologi övergripande,Institutionen för kliniska vetenskaper, Lund,Medical oncology,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Lymphoma - Clinical Research,Lund University Research Groups,LUCC: Lund University Cancer Centre,Other Strong Research Environments,Oncology corporate,Department of Clinical Sciences, Lund,Skåne University Hospital,Lund Univ, Inst Clin Sci, Dept Oncol, SE-22185 Lund, Sweden.;Skane Univ Hosp, SE-22185 Lund, Sweden.;Skane Univ Hosp, Dept Oncol, Lasarettsgatan 23A, SE-22185 Lund, Sweden.;Lund Univ, Lasarettsgatan 23A, SE-22185 Lund, Sweden.
Kolstad, Arne (författare)
Innlandet Hosp, Dept Pathol, Brumunddal, Norway.,Innlandet Hospital Trust
Hutchings, Martin (författare)
Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
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Pasanen, Annika (författare)
Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
Meriranta, Leo (författare)
Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
Niemann, Carsten Utoft (författare)
Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
Jorgensen, Rasmus Rask Kragh (författare)
Aalborg Univ Hosp, Dept Hematol, Aalborg, Denmark.;Aalborg Univ, Dept Clin Med, Aalborg, Denmark.,Aalborg University Hospital
El-Galaly, Tarec Christoffer (författare)
Aalborg Univ Hosp, Dept Hematol, Aalborg, Denmark.;Aalborg Univ, Dept Clin Med, Aalborg, Denmark.,Aalborg University Hospital
Riise, Jon (författare)
Oslo Univ Hosp, Dept Oncol, Oslo, Norway.,Oslo university hospital
Leppa, Sirpa (författare)
Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
Christensen, Jacob Haaber (författare)
Odense Univ Hosp, Dept Hematol, Odense, Denmark.,Odense University Hospital
Sonnevi, Kristina (författare)
Karolinska Institute,Karolinska Institutet,Karolinska University Hospital,Karolinska Univ Hosp, Dept Hematol, Stockholm, Sweden.;Karolinska Inst, Dept Med Huddinge, Stockholm, Sweden.
Pedersen, Lone Bredo (författare)
Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
Wader, Karin Fahl (författare)
St Olavs Univ Hosp, Dept Oncol, Trondheim, Norway.,St. Olav’s University Hospital
Glimelius, Ingrid, 1975- (författare)
Uppsala University,Uppsala universitet,Cancerprecisionsmedicin
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 (creator_code:org_t)
American Society of Hematology, 2024
2024
Engelska.
Ingår i: Blood Advances. - : American Society of Hematology. - 2473-9529 .- 2473-9537. ; 8:2, s. 407-415
Relaterad länk:
http://dx.doi.org/10... (free)
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https://urn.kb.se/re...
https://doi.org/10.1...
http://kipublication...
https://lup.lub.lu.s...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Despite improvements in treatment of mantle cell lymphoma (MCL), most patients eventually relapse. In this multicenter phase 1b/2 trial, we evaluated safety and efficacy of minimal residual disease (MRD)-driven venetoclax, lenalidomide, and rituximab (venetoclax-R2) in relapsed/refractory (R/R) MCL and explored the feasibility of stopping treatment in molecular remission. The primary end point was overall response rate (ORR) at 6 months. After dose escalation, the recommended phase 2 dose was lenalidomide 20 mg daily, days 1 to 21; venetoclax 600 mg daily after ramp-up; and rituximab 375 mg/m(2) weekly for 4 weeks, then every 8 weeks. MRD monitoring by RQ-PCR was performed every 3 months. When MRD-negativity in the blood was reached, treatment was continued for another 3 months; if MRD-negativity was then confirmed, treatment was stopped. In total, 59 patients were enrolled, with a median age of 73 years. At 6 months, the ORR was 63% (29 complete remission [CR], 8 partial remission [PR]), and 40% (4 CR, 2 PR) for patients previously failing a Bruton tyrosine kinase (BTK) inhibitor. Median progression-free survival (PFS) was 21 months, with median overall survival of 31 months. TP53 mutation was associated with inferior PFS (P < .01). Overall, 28 patients (48%) discontinued treatment in molecular remission, and 25 remain MRD negative after a median of 17.4 months. Hematological toxicity was frequent, with 52 of 59 (88%) patients with G3-4 neutropenia and 21 of 59 (36%) patients with G3-4 thrombocytopenia. To conclude, MRD-driven venetoclax-R2 is feasible and tolerable and shows efficacy in R/R MCL, also after BTK inhibitor failure.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Hematologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Hematology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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