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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

Must not have

Patients with chemotherapy resistant disease

Patients with unrelated active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years post transplant

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My Lymphoblastic Lymphoma is in second or later complete remission or in first or later partial remission.

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I have Mature T-Cell Lymphoma and have undergone initial therapy.

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My organs are functioning well, and any issues are not caused by my cancer.

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My Non-Hodgkin's Lymphoma responds to chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer did not respond to chemotherapy.

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I have an active infection that is not related to my current illness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years post transplant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival Comparison

Secondary study objectives

Neutrophil engraftment

Overall Survival

Platelet engraftment

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2960