NCT02169505

Brentuximab Vedotin in High-Risk CD30+ Lymphoma Post Allogeneic Stem Cell Transplantation (AlloSCT)

Terminated Phase 2 Results posted Last updated 27 November 2019

What this trial tests

Phase 2 trial testing Brentuximab Vedotin in Lymphoma in 2 participants. Terminated before completion.

Timeline

22 May 2015

Primary endpoint
14 August 2017

14 August 2017

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	22 May 2015
Primary completion	14 August 2017
Estimated completion	14 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Brentuximab Vedotin — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

Adults 18 to 65, any sex, with Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Secondary Graft Failure Primary · An average of 12 months

Safety is defined by no more than two secondary graft failures within 6 months of transplant (Day 0), based on an observed graft failure rate of \<10% using standard of care treatment. If at any time more than two of these events are observed during the specified time frame, the study will be stopped and no further patients will be accrued.

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Hematologic Toxicity Secondary · an average of 12 months

The most common grade \> 3 side effects on Brentuximab.

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Relapse Secondary · an average of 12 months

Evaluate the safety of brentuximab early after allogeneic stem cell transplant and haploidentical allogeneic transplantant and observe if there is a decrease in the risk of relapse.

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Incidence of Cytomegalovirus (CMV) Reactivation and/or CMV Disease. Secondary · an average of 12 months

Evaluate the CMV in blood

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Acute Graft-versus-host Disease (GVHD). Secondary · an average of 12 months

The tissue and serum in participants were measured by the GVHD

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Central and Effector Cell Effects Secondary · an average of 12 months

We will perform on peripheral blood for mononuclear cells (PBMC) and serum collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as other immune subsets.

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Change in Serum CD30 Levels After Brentuximab Administration Secondary · an average of 12 months

Immunological correlative studies on peripheral blood mononuclear cells (PBMC) and serum will be collected from participants at baseline (prior to initiation of brentuximab therapy) and on days 1, 3, and 5 after initiation of brentuximab and every 21 days thereafter to assess the effect on T cell subsets and their effector function as well as CD30 levels.

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	0

Number of Participants With Progression-Free Survival and Overall Survival on Brentuximab Maintenance Secondary · an average of 12 months

The Kaplan-Meier (1958) survival curves were used to estimate the overall survival and progression-free survival. Cox proportional hazards regression analysis was used to model the association between overall survival and progression-free survival and disease and demographic covariates of interest.

Overall

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	1

Progression-free survival

Group	Value	95% CI
1.2 mg/kg for C1-2 Then 1.8mg/kg for C3-6	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (4 terms — click to expand)

Reaction	System	Treatment Arm
Decreased ANC	Blood and lymphatic system disorders	—
Dcreased WBC	Blood and lymphatic system disorders	—
Decreased PLT	Blood and lymphatic system disorders	—
Skin Rash	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT02169505 adverse events section.

Sponsor's own description

The goal of this clinical research study is to study the safety of ADCETRISTM (brentuximab vedotin) in patients with Hodgkin lymphoma or ALCL who have had an allogeneic or haploidentical stem cell transplant. Another goal of this study is to learn if brentuximab vedotin can help to prevent the disease from coming back.

Publications & conference data

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

1. Anaplastic large cell lymphoma: pathology, genetics, and clinical aspects.
   Tsuyama N, Sakamoto K, Sakata S, Dobashi A, et al · · 2017 · cited 79× · PMID 29279550 · DOI 10.3960/jslrt.17023
2. Brentuximab vedotin for treatment of non-Hodgkin lymphomas: A systematic review.
   Berger GK, McBride A, Lawson S, Royball K, et al · · 2017 · cited 58× · PMID 28010897 · DOI 10.1016/j.critrevonc.2016.11.009
3. Unlocking the NF-κB Conundrum: Embracing Complexity to Achieve Specificity.
   Begalli F, Bennett J, Capece D, Verzella D, et al · · 2017 · cited 51× · PMID 28829404 · DOI 10.3390/biomedicines5030050
4. The NF-κB Pharmacopeia: Novel Strategies to Subdue an Intractable Target.
   Verzella D, Cornice J, Arboretto P, Vecchiotti D, et al · · 2022 · cited 23× · PMID 36140335 · DOI 10.3390/biomedicines10092233
5. Adult systemic anaplastic large-cell lymphoma: recommendations for diagnosis and management.
   Bennani-Baiti N, Ansell S, Feldman AL. · · 2016 · cited 15× · PMID 26581318 · DOI 10.1586/17474086.2016.1122514