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Alkylating agents

MB-102 for Blastic Plasmacytoid Dendritic Cell Neoplasm

Q: What are the primary usages for MB-102?

<p>While most commonly used to treat <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, MB-102 has also been found effective in managing mixed-cell type <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic, acute, and retinoblastoma.</p>

Phase 1 & 2

Waitlist Available

Led By Lihua E Budde, MD

Research Sponsored by Mustang Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, MB-102, to see if it is safe and effective in treating patients with a certain type of blood cancer that has come back or has not responded to other treatments.

Eligible Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Maximum Tolerated Dose (MTD) and recommended Phase 2 dose

Phase 1: Safety and Tolerability as measured by the number of patients with treatment related adverse events

Phase 2: Response Rate of patients with BPDCN

Secondary outcome measures

Phase 2 - Adverse events

Phase 2 - Change from Baseline in the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) Version 4.0.

Phase 2 - Number of patients showing evidence of replication competent lentivirus

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Relapsed or Refractory BPDCNExperimental Treatment3 Interventions

Treatment with MB-102.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

MB-102

2019

Completed Phase 3

~280

Cyclophosphamide

1995

Completed Phase 3

~3780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Mustang BioLead Sponsor

3 Previous Clinical Trials

668 Total Patients Enrolled

Lihua E Budde, MDPrincipal InvestigatorCity of Hope Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary usages for MB-102?

"While most commonly used to treat multiple sclerosis, MB-102 has also been found effective in managing mixed-cell type lymphoma, leukemia, myelocytic, acute, and retinoblastoma."

Answered by AI

What primary goal does this research seek to obtain?

"The purpose of this 28-day study is to Phase 2: Response Rate of patients with BPDCN. Additionally, researchers will be looking at secondary outcomes including Phase 2: BPDCN - MRD (CR MRD- Response Rate for patients with CR and CRi), Phase 2: BPDCN - PFS (Progression-Free Survival), and Phase 2: BPDCN - OS (overall survival)."

Answered by AI

At how many different hospitals or treatment centers will this research be conducted?

"That is correct. The clinicaltrials.gov website says that this study is open for recruitment and has been since February 17th, 2020. As of July 12th, 2022, the trial needs 44 more patients from 4 sites total."

Answered by AI

Is this research looking for test subjects at the moment?

"The most recent information on clinicaltrials.gov suggests that this trial is still seeking patients. The original posting was on February 17th, 2020 and the last update was July 12th, 2022."

Answered by AI

Could you please list other research studies that have used MB-102?

"The first study investigating MB-102 was completed in 1997 at City of Hope Comprehensive Cancer Center. As of now, 1274 studies have been wrapped up with 929 more currently active. The majority of these ongoing investigations are based out of Duarte, California."

Answered by AI

Are there any other hospitals conducting this research in our state?

"4 sites are actively recruiting patients for this study. The City of Hope Medical Center in Duarte, MD Anderson Cancer Center in Houston, and Duke University in Durham have been approved to enroll participants. There are 4 other potential locations where the study might be conducted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.

2020. "Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04109482.