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Chemotherapy

Auto Stem Cell Transplant for Lymphoma

Phase 2
Recruiting
Led By Veronika Bachanova, MD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Lymphoblastic Lymphoma in second or greater complete remission (CR) or first or subsequent partial remission (PR) are eligible
Patients with Mature T-Cell Lymphoma including specific subtypes are eligible after initial therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years post transplant
Awards & highlights

Study Summary

This trial is testing whether autologous transplant, which is using a person's own cells, is effective for treating Hodgkin and non-Hodgkin lymphomas in HIV positive patients.

Who is the study for?
This trial is for lymphoma patients, including those with HIV, who have not responded well to previous treatments. They must be in good physical condition (Karnofsky/Lansky score ≥80%), without severe liver disease or serious organ dysfunction. Eligible participants include those with various types of lymphoma such as Mature T-Cell and Mantle Cell Lymphoma after certain responses to therapy, and specific criteria are set for Hodgkin's Lymphoma stages and treatment responses.Check my eligibility
What is being tested?
The study tests autologous stem cell transplantation combined with chemotherapy drugs like Etoposide, AraC, G-CSF, Cyclophosphamide, BCNU, Melphalan and procedures like Total Body Irradiation on patients with Hodgkin's and non-Hodgkin's lymphomas. It aims to see how effective this approach is for those who haven't had success with other treatments.See study design
What are the potential side effects?
Potential side effects may include nausea from chemotherapy drugs; low blood counts leading to infection risk; mouth sores; hair loss; fatigue due to the transplant process; organ inflammation from radiation exposure; fertility issues post-treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Lymphoblastic Lymphoma is in second or later complete remission or in first or later partial remission.
Select...
I have Mature T-Cell Lymphoma and have undergone initial therapy.
Select...
My organs are functioning well, and any issues are not caused by my cancer.
Select...
My Non-Hodgkin's Lymphoma responds to chemotherapy.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival Comparison
Secondary outcome measures
Neutrophil engraftment
Overall Survival
Platelet engraftment
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: CY/TBIExperimental Treatment4 Interventions
Cyclophosphamide/Total Body Irradiation (CY/TBI) for patients with recent history of CNS lymphoma or those with allergies/contra-indications to agents used in BEAM
Group II: CBV: HLExperimental Treatment3 Interventions
Cyclophosphamide, BCNU and VP-16 (CBV) for HL patients
Group III: BEAM: NHL & HLExperimental Treatment6 Interventions
BCNU, etoposide, Ara-C and melphalan (BEAM) for all NHL and those HL patients who are unable to receive CBV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Peripheral blood stem cell transplantation
1995
Completed Phase 3
~910
G-CSF
2014
Completed Phase 4
~1610
Cyclophosphamide
1995
Completed Phase 3
~3770
BCNU
1996
Completed Phase 3
~1620
Melphalan
2008
Completed Phase 3
~1500
Total Body Irradiation
2006
Completed Phase 3
~820

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,475 Total Patients Enrolled
Veronika Bachanova, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
5 Previous Clinical Trials
555 Total Patients Enrolled

Media Library

BCNU (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03125642 — Phase 2
Hodgkin's Lymphoma Research Study Groups: BEAM: NHL & HL, CBV: HL, CY/TBI
Hodgkin's Lymphoma Clinical Trial 2023: BCNU Highlights & Side Effects. Trial Name: NCT03125642 — Phase 2
BCNU (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03125642 — Phase 2

Frequently Asked Questions

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

Could you please list other similar medical research studies that have been conducted with Peripheral blood stem cell transplantation?

"There are a total of 1277 clinical trials for Peripheral blood stem cell transplantation currently underway. 258 of those trials are in the final Phase 3. Most of the many trials for this treatment are based in Philadelphia, Pennsylvania, but there are 41625 locations running studies related to this intervention across the globe."

Answered by AI

Has the FDA cleared peripheral blood stem cell transplantation for use?

"While there is some evidence that this procedure is safe, it remains in Phase 2 testing and has yet to show any efficacy."

Answered by AI

How many people are selected to participate in this experiment?

"That is accurate. The clinicaltrials.gov website shows that this trial is still searching for participants. It was first posted on 4/20/2017, and the most recent update was 1/3/2022. They are looking for 150 patients from 1 site."

Answered by AI

Can people with the appropriate medical conditions join this trial at this time?

"Yes, this clinical trial is still searching for participants and was most recently updated on January 3rd, 2022."

Answered by AI

To what purpose is Peripheral blood stem cell transplantation most commonly employed?

"Peripheral blood stem cell transplantation is a standard treatment for lung cancers, as well as other diseases like small cell lung cancer (sclc), multiple sclerosis, leukemia, and myelocytic acute."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Auto Stem Cell Transplant for Lymphoma Patients
2017. "Auto Stem Cell Transplant for Lymphoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03125642.
~25 spots leftby Sep 2025
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