Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, B-Cell

Plasmablastic Lymphoma

Lymphoma, Large-Cell, Immunoblastic

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma, Large B-Cell, Diffuse

Lymphosarcoma

B-cell Lymphoma

Lymphoma, Large-cell, Immunoblastic

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

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

Belantamab Mafodotin

Jacob Soumerai, MD

Jacob D. Soumerai, MD

Andrew D Zelenetz, MD, PhD

Raphael Steiner, MD

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.

This is a multicenter phase 2 study of belantamab mafodotin on participants with plasmablastic lymphoma and ALK+ large B-cell lymphoma.The research study procedures include screening for eligibility, and study treatment, including evaluations and follow up visits.

* This research study involves the study drug belantamab mafodotin.
* Participants may receive the study treatment until progression or intolerance, and will be followed up to 2 years.
* It is expected that about 25 people will take part in this research study.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved belantamab mafodotin as a treatment for any disease. This study drug is investigational, and it is not known whether participants will benefit from taking belantamab mafodotin.

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

A Multicenter Phase 2 Study of Belantamab Mafodotin in Relapsed or Refractory Plasmablastic Lymphoma and ALK+ Large B-cell Lymphoma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

An objective response rate (ORR, PR or better) of at least 30% will be considered promising whereas an ORR of 10% or less will be considered non-promising. The responses will classified per the 2014 Lugano criteria. The frequency of complete response will be tabulated and summarized descriptively.

Patients will have their response classified per the 2014 Lugano criteria. The frequency of complete response will be tabulated and summarized descriptively.

Median Progression-free survival will be summarized using Kaplan-Meier method with time of registration as time origin. Participants will be followed for 2 years after removal from protocol therapy or until death, whichever occurs first. Participants will be censored at the date of their last evaluation.

Overall survival will be summarized using Kaplan-Meier method with time of registration as time origin. Participants will be followed for 2 years after removal from protocol therapy or until death, whichever occurs first. Participants will be censored at the date of their last evaluation.

Patients will have their toxicities graded and reported at every visit according to criteria listed in CTAE ver. 5.0. The nature, frequency, severity, and timing of adverse events will be tabulated and summarized descriptive

Spots Global Cancer Trial Database for relapsed plasmablastic lymphom