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Procedure

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 below

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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:

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of treatment (estimated to be 6 months) for reporting.

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