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MRD-driven treatmen...
MRD-driven treatment with venetoclax-R2 in mantle cell lymphoma : the Nordic Lymphoma Group MCL7 VALERIA trial
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- Jerkeman, Mats (author)
- 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.
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- Kolstad, Arne (author)
- Innlandet Hosp, Dept Pathol, Brumunddal, Norway.,Innlandet Hospital Trust
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- Hutchings, Martin (author)
- Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
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- Pasanen, Annika (author)
- Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
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- Meriranta, Leo (author)
- Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
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- Niemann, Carsten Utoft (author)
- Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
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- Jorgensen, Rasmus Rask Kragh (author)
- Aalborg Univ Hosp, Dept Hematol, Aalborg, Denmark.;Aalborg Univ, Dept Clin Med, Aalborg, Denmark.,Aalborg University Hospital
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- El-Galaly, Tarec Christoffer (author)
- Aalborg Univ Hosp, Dept Hematol, Aalborg, Denmark.;Aalborg Univ, Dept Clin Med, Aalborg, Denmark.,Aalborg University Hospital
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- Riise, Jon (author)
- Oslo Univ Hosp, Dept Oncol, Oslo, Norway.,Oslo university hospital
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- Leppa, Sirpa (author)
- Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.,Helsinki University Central Hospital
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- Christensen, Jacob Haaber (author)
- Odense Univ Hosp, Dept Hematol, Odense, Denmark.,Odense University Hospital
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- Sonnevi, Kristina (author)
- Karolinska Institute,Karolinska Institutet,Karolinska University Hospital,Karolinska Univ Hosp, Dept Hematol, Stockholm, Sweden.;Karolinska Inst, Dept Med Huddinge, Stockholm, Sweden.
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- Pedersen, Lone Bredo (author)
- Rigshosp, Dept Hematol, Copenhagen, Denmark.,Copenhagen University Hospital
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- Wader, Karin Fahl (author)
- St Olavs Univ Hosp, Dept Oncol, Trondheim, Norway.,St. Olav’s University Hospital
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- Glimelius, Ingrid, 1975- (author)
- Uppsala University,Uppsala universitet,Cancerprecisionsmedicin
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(creator_code:org_t)
- American Society of Hematology, 2024
- 2024
- English.
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In: Blood Advances. - : American Society of Hematology. - 2473-9529 .- 2473-9537. ; 8:2, s. 407-415
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Abstract
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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.
Subject headings
- 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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- art (subject category)
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- By the author/editor
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Jerkeman, Mats
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Kolstad, Arne
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Hutchings, Marti ...
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Pasanen, Annika
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Meriranta, Leo
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Niemann, Carsten ...
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Jorgensen, Rasmu ...
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El-Galaly, Tarec ...
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Riise, Jon
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Leppa, Sirpa
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Christensen, Jac ...
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Sonnevi, Kristin ...
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Pedersen, Lone B ...
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Wader, Karin Fah ...
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Glimelius, Ingri ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Hematology
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Blood Advances
- By the university
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Uppsala University
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Karolinska Institutet
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Lund University