Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma : the phase II HOVON/LLPC Transplant BRaVE study
Achieving a metabolic complete response (mCR) before high-dose chemotherapy (HDC) and autologous peripheral blood stem-cell transplant (auto-PBSCT) predicts progression free survival (PFS) in relapsed/refractory classical Hodgkin lymphoma (R/R cHL). We added brentuximab vedotin (BV) to DHAP to improve the mCR rate. In a Phase I dose-escalation part in 12 patients, we showed that BV-DHAP is feasible. This Phase II study included 55 R/R cHL patients (23 primary refractory). Treatment consisted of three 21-day cycles of BV 1.8 mg/kg on day 1, and DHAP (dexamethasone 40mg days 1-4, cisplatin 100mg/m2; day 1 and cytarabine 2x2g/m2; day 2). Patients with a metabolic partial response (mPR) or mCR proceeded to HDC/auto-PBSCT. Based on independent central FDG-PET-CT review, 42 of 52 evaluable patients (81% [95% CI: 67-90]) achieved an mCR before HDC/auto-PBSCT, five had an mPR and five had progressive disease (three were not evaluable). After HDC/auto-PBSCT, four patients with an mPR converted to an mCR. The 2-year PFS was 74% [95% CI: 63-86], and the overall survival 95% [95% CI: 90-100]. Toxicity was manageable and mainly consisted of grade 3/4 hematological toxicity, fever, nephrotoxicity, ototoxicity (grade 1/2) and transiently elevated liver enzymes during BV-DHAP. Eighteen patients developed new onset peripheral neuropathy (maximum grade 1/2) and all recovered. In conclusion, BV-DHAP is a very effective salvage regimen in R/R cHL patients, but patients should be monitored closely for toxicity. ClinicalTrials.gov identifier: NCT02280993.
| Errataetall: |
CommentIn: Haematologica. 2021 Apr 01;106(4):1226-1227. - PMID 33792226 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2021 |
|---|---|
| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:106 |
|---|---|
| Enthalten in: |
Haematologica - 106(2021), 4 vom: 01. Apr., Seite 1129-1137 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kersten, Marie José [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
04079A1RDZ |
|---|
| Anmerkungen: |
Date Completed 27.05.2021 Date Revised 31.03.2024 published: Electronic ClinicalTrials.gov: NCT02280993 CommentIn: Haematologica. 2021 Apr 01;106(4):1226-1227. - PMID 33792226 Citation Status MEDLINE |
|---|
| doi: |
10.3324/haematol.2019.243238 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM308586212 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM308586212 | ||
| 003 | DE-627 | ||
| 005 | 20240331232111.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2021 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3324/haematol.2019.243238 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1358.xml |
| 035 | |a (DE-627)NLM308586212 | ||
| 035 | |a (NLM)32273476 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kersten, Marie José |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Combining brentuximab vedotin with dexamethasone, high-dose cytarabine and cisplatin as salvage treatment in relapsed or refractory Hodgkin lymphoma |b the phase II HOVON/LLPC Transplant BRaVE study |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 27.05.2021 | ||
| 500 | |a Date Revised 31.03.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT02280993 | ||
| 500 | |a CommentIn: Haematologica. 2021 Apr 01;106(4):1226-1227. - PMID 33792226 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Achieving a metabolic complete response (mCR) before high-dose chemotherapy (HDC) and autologous peripheral blood stem-cell transplant (auto-PBSCT) predicts progression free survival (PFS) in relapsed/refractory classical Hodgkin lymphoma (R/R cHL). We added brentuximab vedotin (BV) to DHAP to improve the mCR rate. In a Phase I dose-escalation part in 12 patients, we showed that BV-DHAP is feasible. This Phase II study included 55 R/R cHL patients (23 primary refractory). Treatment consisted of three 21-day cycles of BV 1.8 mg/kg on day 1, and DHAP (dexamethasone 40mg days 1-4, cisplatin 100mg/m2; day 1 and cytarabine 2x2g/m2; day 2). Patients with a metabolic partial response (mPR) or mCR proceeded to HDC/auto-PBSCT. Based on independent central FDG-PET-CT review, 42 of 52 evaluable patients (81% [95% CI: 67-90]) achieved an mCR before HDC/auto-PBSCT, five had an mPR and five had progressive disease (three were not evaluable). After HDC/auto-PBSCT, four patients with an mPR converted to an mCR. The 2-year PFS was 74% [95% CI: 63-86], and the overall survival 95% [95% CI: 90-100]. Toxicity was manageable and mainly consisted of grade 3/4 hematological toxicity, fever, nephrotoxicity, ototoxicity (grade 1/2) and transiently elevated liver enzymes during BV-DHAP. Eighteen patients developed new onset peripheral neuropathy (maximum grade 1/2) and all recovered. In conclusion, BV-DHAP is a very effective salvage regimen in R/R cHL patients, but patients should be monitored closely for toxicity. ClinicalTrials.gov identifier: NCT02280993 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Cytarabine |2 NLM | |
| 650 | 7 | |a 04079A1RDZ |2 NLM | |
| 650 | 7 | |a Dexamethasone |2 NLM | |
| 650 | 7 | |a 7S5I7G3JQL |2 NLM | |
| 650 | 7 | |a Brentuximab Vedotin |2 NLM | |
| 650 | 7 | |a 7XL5ISS668 |2 NLM | |
| 650 | 7 | |a Cisplatin |2 NLM | |
| 650 | 7 | |a Q20Q21Q62J |2 NLM | |
| 700 | 1 | |a Driessen, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Zijlstra, Josée M |e verfasserin |4 aut | |
| 700 | 1 | |a Plattel, Wouter J |e verfasserin |4 aut | |
| 700 | 1 | |a Morschhauser, Franck |e verfasserin |4 aut | |
| 700 | 1 | |a Lugtenburg, Pieternella J |e verfasserin |4 aut | |
| 700 | 1 | |a Brice, Pauline |e verfasserin |4 aut | |
| 700 | 1 | |a Hutchings, Martin |e verfasserin |4 aut | |
| 700 | 1 | |a Gastinne, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Burggraaff, Coreline N |e verfasserin |4 aut | |
| 700 | 1 | |a Nijland, Marcel |e verfasserin |4 aut | |
| 700 | 1 | |a Tonino, Sanne H |e verfasserin |4 aut | |
| 700 | 1 | |a Arens, Anne I J |e verfasserin |4 aut | |
| 700 | 1 | |a Valkema, Roelf |e verfasserin |4 aut | |
| 700 | 1 | |a van Tinteren, Harm |e verfasserin |4 aut | |
| 700 | 1 | |a Lopez-Yurda, Marta |e verfasserin |4 aut | |
| 700 | 1 | |a Diepstra, Arjan |e verfasserin |4 aut | |
| 700 | 1 | |a De Jong, Daphne |e verfasserin |4 aut | |
| 700 | 1 | |a Hagenbeek, Anton |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Haematologica |d 1947 |g 106(2021), 4 vom: 01. Apr., Seite 1129-1137 |w (DE-627)NLM000081892 |x 1592-8721 |7 nnns |
| 773 | 1 | 8 | |g volume:106 |g year:2021 |g number:4 |g day:01 |g month:04 |g pages:1129-1137 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3324/haematol.2019.243238 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 106 |j 2021 |e 4 |b 01 |c 04 |h 1129-1137 | ||