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Thiotepa + Stem Cell Transplant for Lymphoma (CNS-PHLAT Trial)
Saint Louis, MO
Phase 2
Recruiting
Led By Amanda F Cashen, 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
Ages 18 to 75
Newly diagnosed diffuse large B-cell lymphoma, large B-cell lymphoma transformed from underlying indolent lymphoma, or high-grade B-cell lymphoma
Must not have
Diagnosis of primary CNS lymphoma
Diagnosis of secondary CNS involvement at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of treatment (estimated to be 6 months)
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to see if giving patients with diffuse large B-cell lymphoma a specific treatment after their initial therapy can help prevent the cancer from coming back in the central nervous system. They want to test
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Who is the study for?
This trial is for high-risk patients with Diffuse Large B-cell Lymphoma (DLBCL) who are in their first complete remission and eligible for a stem cell transplant. It's not suitable for those with prior central nervous system disease or other conditions that would exclude them from safely receiving the treatments being tested.Check my eligibility
What is being tested?
The study is testing if using Thiotepa and Carmustine as part of an autologous stem cell transplant can prevent brain relapse in DLBCL patients at high risk. This approach is compared to the standard BEAM regimen, which includes different chemotherapy drugs.See study design
What are the potential side effects?
Potential side effects include reactions to chemotherapy like nausea, hair loss, fatigue, increased infection risk due to low blood counts, and complications related to stem cell transplantation such as graft failure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I have been diagnosed with a type of aggressive B-cell lymphoma.
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I can take care of myself but might not be able to do heavy physical work.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with lymphoma in my brain or spinal cord.
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My cancer has spread to my brain.
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My lymphoma has returned or did not respond to treatment.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of treatment (estimated to be 6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of treatment (estimated to be 6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Anthracycline-based induction chemotherapy + ASCT + Thiotepa + CarmustineExperimental Treatment4 Interventions
* Patients should receive induction treatment with anthracycline-based chemotherapy regimen per standard of care (6 cycles). Management, dose delays, and dose modifications will be per standard of care and treating physician discretion; administration of anthracycline-based induction therapy is not dictated by the study. Patients who have a PR by PET criteria but whose residual abnormality on PET is unlikely to represent residual disease may proceed to ASCT.
* After confirmation of complete response (CR) following induction therapy, patients will begin conditioning with thiotepa (days -5 and -4) and carmustine (day -6), followed by ASCT on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Autologous Stem Cell Transplant
2016
Completed Phase 2
~480
Thiotepa
2008
Completed Phase 3
~2280
Carmustine
1990
Completed Phase 3
~1820
Find a Location
Closest Location:Washington University School of Medicine· Saint Louis, MO· 396 miles
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
2,022 Previous Clinical Trials
2,351,457 Total Patients Enrolled
Amanda F Cashen, M.D.Principal InvestigatorWashington University School of Medicine