NCT02243436

Phase I-II Clinical Trial for the Evaluation of Brentuximab Vedotin Plus Etoposide, Solumoderin (Methylprednisolone), High Dose ARA-C (Cytarabine) and Cisplatin in the Transplant and Post-transplant Management for Relapsed or Refractory Classical Hodgkin Lymphoma Patients

Completed Phase 1/Phase 2 Last updated 23 April 2019

What this trial tests

Phase 1/Phase 2 trial testing Brentuximab Vedotin in CLASSICAL HODGKIN LYMPHOMA in 67 participants. Completed in 14 January 2019.

Timeline

11 November 2014

Primary endpoint
1 January 2019

14 January 2019

Quick facts

Lead sponsor	Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	11 November 2014
Primary completion	1 January 2019
Estimated completion	14 January 2019
Sites	14 locations across Spain

Drugs / interventions tested

• Brentuximab Vedotin — full drug profile →
• Etoposide (etoposide) — full drug profile →
• Soludomerin — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Ara C

Conditions studied

• CLASSICAL HODGKIN LYMPHOMA — all drugs for CLASSICAL HODGKIN LYMPHOMA →

Sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea — full company profile →

Who can join

18 and older, any sex, with CLASSICAL HODGKIN LYMPHOMA. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Recommended dose
  Time frame: Day 21 of cycle 1 (3 weeks after start of treatment)
  During phase I, defined as the maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant HL patients.
• Global response rate prior to ASCT
  Time frame: 9 weeks (after start of treatment)
  During phase II, Global response rate after BV-ESHAP as salvage regimen prior to ASCT.
• Complete response
  Time frame: 9 weeks (after start of treatment)
  Percentage of patients with complete response rate after BV-ESHAP as salvage regimen prior to ASCT.

Sponsor's own description

Phase I trial aimed to determine the Maximum Tolerable Dose of the BV in combination with ESHAP in relapsed/resistant Hodgkin Lymphona patients and to evaluate response to treatment with BV-ESHAP as salvage regimen prior to autologous stem cell transplantation.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Treatment Options for Paediatric Anaplastic Large Cell Lymphoma (ALCL): Current Standard and beyond.
   Prokoph N, Larose H, Lim MS, Burke GAA, et al · · 2018 · cited 58× · PMID 29601554 · DOI 10.3390/cancers10040099
2. The promising role of antibody drug conjugate in cancer therapy: Combining targeting ability with cytotoxicity effectively.
   Li WQ, Guo HF, Li LY, Zhang YF, et al · · 2021 · cited 36× · PMID 34165267 · DOI 10.1002/cam4.4052
3. Current advances in Hodgkin's lymphoma.
   Vadakara J, Andrick B. · · 2019 · cited 4× · PMID 30993260 · DOI 10.1016/j.cdtm.2019.02.003
4. Abstract Book for the 27th Congress of the European Hematology Association
   · 2022
5. P1083: BRENTUXIMAB VEDOTIN, ETOPOSIDE, SOLUMEDROL, HIGH DOSE ARA-C & PLATINUM FOLLOWED BY HDT & APBSCT FOR REFRACTORY/RELAPSED HODGKIN LYMPHOMA PATIENTS: LONG-TERM RESULTS OF THE GELTAMO GROUP BRESHAP STUDY
   Garcia-Sanz R, Martínez C, De la Cruz F, González A, et al · · 2022