trialsTrialActive

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

A phase 1/2 trial of Brentuximab vedotin, Doxorubicin, Vinblastine and Dacarbazine in hodgkin lymphoma, run by Takeda, active and no longer recruiting.

A Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Participants With Advanced Stage Newly Diagnosed Hodgkin Lymphoma is a phase 1/2 interventional study registered as NCT02979522 by Takeda, with 59 participants enrolled, started 2017-09-06 and due to reach its primary completion in 2020-05-05. Interventions recorded: Brentuximab vedotin, Doxorubicin, Vinblastine and Dacarbazine. Results have been posted on the registry.

Setting

An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma

Phase

Phase 1/2

Sponsor

Takeda

Registry

Started

2017-09-06

Reported

2021

Enrolled

59 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

59 enrolled

Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visitprimarysurrogate endpoint

75 vs 76 out of 100 had no sign of cancer on scans or tests with Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD compared with Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD; 1 fewer per 100.
On this measure the first group did worse, not better.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visitprimaryresponse endpoint

86 vs 88 out of 100 had their tumour shrink with Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD compared with Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD; 2 fewer per 100.
On this measure the first group did worse, not better.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: An Open-Label Study of Brentuximab Vedotin + Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma. People in a different situation may not see the same effect.
Only 59 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

59 enrolled.

Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visitprimary

Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD75 of 100

n = 51

Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD76 of 100

n = 59

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95% CI 60 to 86; Figures from the ClinicalTrials.gov results section (first posted 2021-06-01), not from a publication · 95% CI 63 to 86

Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visitprimary

Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD86 of 100

n = 51

Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD88 of 100

n = 59

Download

95% CI 74 to 94; Figures from the ClinicalTrials.gov results section (first posted 2021-06-01), not from a publication · 95% CI 77 to 95

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Phase 2: Percentage of Participants Who Achieved a Complete Remission (CR) Per Independent Review Facility (IRF) Assessment Per International Working Group (IWG) Criteria at End of Treatment (EOT) Visitprimary	Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD	51	75%	-	-	link
	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD	59	76%	-	-	link
Phase 2: Percentage of Participants Who Achieved an Overall Response Rate (ORR) Per IRF Assessment Per IWG Criteria at EOT Visitprimary	Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD	51	86%	-	-	link
	Phase 1 + Phase 2: Brentuximab Vedotin 48 mg/m^2 + AVD	59	88%	-	-	link

Connected

Similar pages

cancers

Advanced-stage classical Hodgkin lymphoma (stage III to IV)Hodgkin lymphoma

technologies

Antibody-drug conjugate (ADC)Cytotoxic chemotherapy

drugs

ApprovedADC

Brentuximab vedotin · Adcetris

ApprovedAlkylating agent (triazene)

Dacarbazine · DTIC-Dome (historic)

ApprovedCytotoxic chemotherapy (anthracycline)

Doxorubicin · Adriamycin

ApprovedVinca alkaloid (microtubule inhibitor)

Vinblastine · Velban

companies