Belantamab Mafodotin In Plasmablastic Lymphoma & ALK+ Large B-Cell Lymphoma

NCT04676360 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-404
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

In this research study is looking to see how safe and effective belantamab mafodotin is in relapsed or refractory plasmablastic lymphoma or ALK+ large B-cell lymphoma.

• This research study involves the study drug belantamab mafodotin.
• Belantamab mafodotin is an antibody-drug conjugate (ADC), which is the combination of an antibody (a protein that binds to cells) and a drug. It works by using the antibody portion to enter into the lymphoma cells, and then releasing the drug portion to kill the lymphoma cells.

Conditions

Relapsed Plasmablastic Lymphoma; Refractory Plasmablastic Lymphoma; Anaplastic Lymphoma Kinase Positive Large B-Cell Lymphoma

Keywords

Relapsed Plasmablastic Lymphom; Refractory Plasmablastic Lymphoma; Anaplastic Lymphoma Kinase Positive Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Proportion of patients who achieved partial response or complete response per 2014 Lugano criteria.

  Measured up to 2 years

Secondary Outcomes (4)

• Complete Response Rate

  Measured up to 2 years

• Progression Free Survival

  2 years

• Overall Survival

  2 years

• Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v5.0

  2 years

Study Arms (1)

(BELANTAMAB MAFODOTIN

EXPERIMENTAL

* Belantamab mafodotin will be administered intravenously on day 1 of a 21-day cycle. * Treatment is intended to be administered on an outpatient basis.

Drug: Belantamab Mafodotin

Interventions

Belantamab Mafodotin DRUG

Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.

Also known as: Blenrep

(BELANTAMAB MAFODOTIN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have relapsed or refractory plasmablastic lymphoma or ALK+ large Bcell lymphoma by WHO criteria.
• Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter \[LDi\] to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥15 mm in LDi for nodal disease or ≥10 mm in LDi for extranodal lesions.
• Participants must have received prior systemic lymphoma therapy.
• Age ≥18 years. Because no dosing or adverse event data are currently available on the use of belantamab mafodotin in participants \<18 years of age, children are excluded from this study.
• ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
• Participants must have adequate marrow function as defined below (unless abnormalities are considered related to marrow and/or splenic involvement by lymphoma):
• absolute neutrophil count ≥1,000/mcL
• platelets ≥50,000/mcL
• hemoglobin ≥ 8.0 g/dL
• Participants must have adequate organ function as defined below:
• total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN); (Isolated bilirubin ≥1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
• Spot urine (albumin/creatinine) \<500 mg/g (56 mg/mmol) OR
• Urine Dipstick Negative/trace (if ≥1+ only eligible if confirmed ≤ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)
• Glomerular filtration rate (eGFR)≥30 mL/min/1.73 m2 (MDRD Formula).

You may not qualify if:

• Participants must not have current corneal epithelial disease except mild changes in corneal epithelium.
• Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
• Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. At the discretion of the overall PI, participants with residual toxicities \> Grade 1 may be considered eligible if in the opinion of the overall PI the residual toxicity is not likely to interfere with the safety or efficacy assessment of the investigational regimen.
• Participants who are receiving any other investigational agents.
• Participants must not have central nervous system involvement by lymphoma, as belantamab mafodotin is not known to penetrate the CNS.
• Participant must not use contact lenses while participating in this study.
• Participant must not be simultaneously enrolled in any interventional clinical trial.
• Participant must not have used an investigational drug or approved systemic lymphoma therapy within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Steroids are permitted.
• Participant must not have had major surgery within 4 weeks of initiating study treatment.
• Participant must not have any evidence of active mucosal or internal bleeding.
• Participants must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.
• Participants must not have an uncontrolled intercurrent illness.
• Participant must not have an uncontrolled active infection.
• Participant must not have evidence of cardiovascular risk including any of the following:
• Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block.

Sponsors & Collaborators

• Jacob Soumerai, MD: lead
• GlaxoSmithKline: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Plasmablastic Lymphoma

Interventions

belantamab mafodotin

Condition Hierarchy (Ancestors)

Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Jacob D. Soumerai, MD
• Organization: Massachusetts General Hospital

jsoumerai@mgh.harvard.edu

6177244000

Study Officials

• Jacob Soumerai, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor Investigator

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: July 1, 2021
• Primary Completion: November 27, 2023
• Study Completion: November 26, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)