Phase 4
N=50
Study of Brentuximab Vedotin in Participants With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01909934 ↗Enrolled (actual)
50
Serious AEs
32.0%
Results posted
May 2022
Primary outcome: Primary: Objective Response Rate (ORR) — 64 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Brentuximab vedotin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
64 | — |
| SECONDARY Duration of Response (DOR) Per IRF |
NA | — |
| SECONDARY Progression-free Survival (PFS) Per IRF |
20.9 | — |
| SECONDARY Complete Remission Rate (CRR) Per IRF |
30 | — |
| SECONDARY Overall Survival (OS) |
67.6 | — |
| SECONDARY Percentage of Participants Receiving Hematopoietic Stem Cell Transplant (SCT) Following Treatment With Brentuximab Vedotin |
28 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs by Severity (Grade 3 or Higher) |
94; 32; 70; 58 | — |
| SECONDARY Concentration of Serum Antibody-drug Conjugate (ADC) at the End of Infusion |
35; 38 | — |
| SECONDARY Concentration of Serum Total Antibody (TAb) Conjugate Plus Free Total Antibody |
33; 38 | — |
| SECONDARY Maximum Concentration for Unconjugated Drug- Monomethyl Auristatin E (MMAE) |
0.25; 0.29 | — |
| SECONDARY Percentage of Participants With Presence of Anti-Therapeutic Antibodies (ATA) and Neutralizing Antibodies (NAb) to Brentuximab Vedotin |
30; 0.0 | — |
Summary
The purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (IV) every 3 weeks, as measured by the overall objective response rate (ORR) in patients with r/r sALCL following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride [hydroxydaunorubicin], vincristine sulfate [Oncovin], and prednisone [CHOP] or equivalent multiagent chemotherapy regimens with curative intent).
Eligibility Criteria
Inclusion Criteria
- Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy
- Bidimensional measurable disease
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence
- Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence
- Clinical laboratory values as specified in the study protocol
Exclusion Criteria
- Previous treatment with brentuximab vedotin.
- Previously received an allogeneic transplant.
- Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).
- Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)
- Female participants who are lactating and breastfeeding or pregnant
- Known human immunodeficiency virus (HIV) positive
- Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
Data sourced from ClinicalTrials.gov (NCT01909934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.