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Blinatumomab + Autologous Stem Cell Transplantation for Diffuse Large B-Cell Lymphoma

Phase 1
Waitlist Available
Led By Armin Ghobadi, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke, sever brain injuries, dementia, or psychosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post-auto-sct
Awards & highlights

Study Summary

This trial will test whether the addition of the drug blinatumomab to standard care after stem cell transplant improves outcomes for patients with DLBCL.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You do not have any significant brain-related conditions like seizures, paralysis, speech problems, stroke, severe head injuries, memory loss, or mental illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years post-auto-sct
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years post-auto-sct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and tolerability of blinatumomab consolidation post auto-SCT as measured by percentage of patients who can finish a full course of blinatumomab post-auto-SCT
Secondary outcome measures
Complete remission rate in patients with residual disease after auto-SCT
Overall survival
Progression-free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: ASCT + BEAM + BlinatumomabExperimental Treatment7 Interventions
Standard of care ASCT with BEAM conditioning (carmustine/etoposide/cytarabine/melphalan) - guidelines below, other conditionings are allowed: carmustine is typically given intravenously (IV) at a dose of 300 mg/m^2 on Day -7 etoposide is typically given IV at a dose of 100 mg/m^2 twice per day (BID) on Days -6, -5, -4, and -3 (8 doses) cytarabine is typically given IV at a dose of 100 mg/m^2 BID on Days -6, -5, -4, and -3 (8 doses) melphalan is typically given IV at a dose of 140 mg/m*2 on Day -2 Auto-SCT will take place on Day 0 as per institutional guidelines Consolidation with blinatumomab will start 6 weeks following auto-SCT. Patients with CR or PR based on pre-transplant PET/CT will receive blinatumomab as a continuous IV infusion (CIVI) at 9μg/day for 1 week, then 28μg/day for 3 weeks (total of 4 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1140
Autologous stem cell transplant
2010
Completed Phase 2
~130
Carmustine
1990
Completed Phase 3
~1790
Etoposide
2010
Completed Phase 3
~2440
Cytarabine
2016
Completed Phase 3
~3310
Melphalan
2008
Completed Phase 3
~1500
Peripheral blood draws
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,297,198 Total Patients Enrolled
AmgenIndustry Sponsor
1,355 Previous Clinical Trials
1,384,057 Total Patients Enrolled
Armin Ghobadi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
110 Total Patients Enrolled

Media Library

Blinatumomab Clinical Trial Eligibility Overview. Trial Name: NCT03072771 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: ASCT + BEAM + Blinatumomab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Blinatumomab Highlights & Side Effects. Trial Name: NCT03072771 — Phase 1
Blinatumomab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03072771 — Phase 1

Frequently Asked Questions

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

How many participants are involved in this clinical investigation?

"At this juncture, there is no recruitment for this trial. It was initially posted on the 1st of August 2017 and has been updated most recently on May 4th 2022. For individuals seeking other studies, 1776 clinical trials are presently enrolling patients with lymphoma large b-cell diffuse and 599 investigations which require an Autologous stem cell transplant also have open enrolment requirements."

Answered by AI

Are there any vacancies left for the clinical trial?

"According to clinicaltrials.gov, the initial post of this trial was on August 1st 2017 and its most recent update occurred on May 4th 2022. Consequently, it is not currently accepting any new patients; however, 2375 other trials are still actively recruiting participants."

Answered by AI

What diseases is Autologous stem cell transplant typically employed to address?

"Autologous stem cell transplant is a therapeutic approach used to treat hematopoietic cells and various other types of cancer such as merkel cell, meningeal leukemia, and prostate."

Answered by AI

Is Autologous stem cell transplantation a safe medical procedure for people?

"Given the limited data regarding Autologous stem cell transplant's safety and efficacy, our team at Power rated this therapy with a score of 1."

Answered by AI
~2 spots leftby Mar 2025