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Bone Marrow Transplant

HST-NEETs + Bone Marrow Transplant for Lymphoma (BMTCTN1903 Trial)

Phase 2
Recruiting
Research Sponsored by Catherine Bollard
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must not have HIV refractory to pharmacologic therapy
Participants must not have an uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

BMTCTN1903 Trial Summary

This trial is testing a new treatment for HIV-associated lymphoma that involves transplanting the patient's own cells, followed by administration of HST-NEETs.

Who is the study for?
This trial is for individuals at least 15 years old with HIV-associated lymphoma, specifically those who have had two or three prior treatments and are responsive to chemotherapy. They must be planning an autologous stem cell transplant (ASCT) and have a Karnofsky performance status of 70% or higher. People with uncontrolled infections, previous cellular therapies, certain heart conditions, resistant HIV strains, or active CNS involvement cannot participate.Check my eligibility
What is being tested?
The trial is testing the effectiveness of HST-NEETs following an autologous stem cell transplant in treating HIV-related lymphomas. It's a Phase II study where all participants receive high-dose chemotherapy followed by ASCT and then the investigational therapy HST-NEETs.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with bone marrow transplants such as infection risk due to immune suppression, graft failure, bleeding complications from low blood counts, reactions to new T-cells including fever and fatigue. Specific side effects of HST-NEETs are not detailed but could align with general cellular therapy adverse events.

BMTCTN1903 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My HIV is under control with medication.
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I do not have any infections that aren't under control.
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I am at least 15 years old.
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I am on HIV medication and my viral load is under control.
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My cancer responded well to the most recent chemotherapy.
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I have never received cellular therapy.
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I am mostly able to care for myself and carry out normal activities.
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I have not had any stem cell or CAR T-cell therapy before.
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I am planning to undergo high dose chemotherapy and a stem cell transplant using my own cells.
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My lymphoma is one of several types and has not responded well to initial treatments or has come back.
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I have been diagnosed with a specific type of advanced lymphoma.

BMTCTN1903 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine 1.) the proportion of participants who can be treated with (HST-NEETs) within 1 week of ASCT in a cooperative multi-institutional setting and 2.) the efficacy of HSTNEETs in reducing the HIV intact proviral
Secondary outcome measures
Progression-free survival
The incidence and severity of acute infusion related toxicities
Other outcome measures
Assessment of plasma DNA in blood (clonal Ig DNA) as a tumor marker
Complete Response(CR) and Complete Response + Partial Response(PR) rates
HIV RNA in plasma
+8 more

BMTCTN1903 Trial Design

1Treatment groups
Experimental Treatment
Group I: HST-NEETsExperimental Treatment2 Interventions
HIV+ Participants that were treated with autologous hematopoietic stem cell transplant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bone Marrow Transplant
2015
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor
13 Previous Clinical Trials
319 Total Patients Enrolled
2 Trials studying Lymphoma
42 Patients Enrolled for Lymphoma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,615 Total Patients Enrolled
42 Trials studying Lymphoma
8,025 Patients Enrolled for Lymphoma
National Marrow Donor ProgramOTHER
60 Previous Clinical Trials
202,548 Total Patients Enrolled
15 Trials studying Lymphoma
107,609 Patients Enrolled for Lymphoma

Media Library

Bone Marrow Transplant (Bone Marrow Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04975698 — Phase 2
Lymphoma Research Study Groups: HST-NEETs
Lymphoma Clinical Trial 2023: Bone Marrow Transplant Highlights & Side Effects. Trial Name: NCT04975698 — Phase 2
Bone Marrow Transplant (Bone Marrow Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975698 — Phase 2

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 currently involved in this investigation?

"This clinical trial is in need of 12 qualified participants across two sites: Columbia University Medical Center, located in New york City, and H. Lee Moffitt Cancer Center based in Tampa. Those who match the specified inclusion criteria can take part in this study."

Answered by AI

Is this treatment safe and effective for human use?

"There is limited data available to support the safety of this medication, thus it was given a score of 2 on our rating scale. It should be noted that this trial is in Phase 2 and yet to provide efficacy evidence."

Answered by AI

How prevalent is this study's implementation in the city at present?

"Patients are being accepted at Columbia University Medical Center in New york, the H. Lee Moffitt Cancer Center in Tampa and Memorial Sloan Kettering (MSKCC) in Houston as well as 16 other sites across the United States of America."

Answered by AI

To what illnesses is this remedy typically administered?

"Allogeneic hematopoietic stem cell transplant has been observed to be a successful treatment for chronic myelogenous leukemia. It may also prove beneficial in treating conditions such as conditioning regimens for allogeneic stem cell transplantation therapy, thrombocythemia, essential thrombocytosis and polycythemia vera (PV)."

Answered by AI

Is this trial presently seeking new participants?

"Affirmative. Clinicaltrials.gov attests to this clinical trial being open for recruitment, having been initially advertised on the 25th of October 2021 and most recently revised on the 2nd of November 2022. This medical endeavour is looking for 12 patients from 16 distinct sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903
Catherine Bollard 2021. "HIV Antigen-specific T-cells Targeting Conserved Epitopes (HST-NEETs) BMTCTN1903". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975698.
~4 spots leftby Jun 2025
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