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Stem Cell Transplantation

Chemotherapy + Stem Cell Transplant + Romidepsin for T-Cell Lymphoma

Phase 2

Waitlist Available

Led By Steven Horowitz, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PTCL, AITL, ALCL, EaTCL, Hepatosplenic Gamma Delta T cell lymphoma, Adult T-cell leukemia/lymphoma, Primary cutaneous gamma/delta T-cell lymphoma, Extranodal NK/T-cell lymphoma, nasal type, Primary cutaneous anaplastic large cell lymphoma, Subcutaneous panniculitis-like T-cell lymphoma, Mycosis fungoides/sezary syndrome

Remission status of CR or PR required

Must not have

Inadequate performance status/organ function

Prior therapy with romidepsin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a chemo drug can help T Cell Non-Hodgkin Lymphoma patients who have had a transplant.

Who is the study for?

This trial is for patients over 16 with T Cell Non-Hodgkin Lymphoma who are eligible for a stem cell transplant. They must have collected enough stem cells, be in remission after chemotherapy, and have normal liver function tests. Excluded are those with progressive disease, previous transplants, active severe infections including HIV, inadequate organ function or performance status, pregnancy or breastfeeding without contraception use, prior romidepsin therapy, CNS involvement by cancer, certain heart conditions or arrhythmias.

What is being tested?

The study is testing the effectiveness of romidepsin as maintenance therapy following high-dose chemotherapy and autologous stem cell transplant in patients with T Cell Non-Hodgkin Lymphoma. Romidepsin will be administered to see if it can help keep the lymphoma from coming back after the transplant.

What are the potential side effects?

Romidepsin may cause side effects such as changes in heartbeat rhythm (QT prolongation), potential infection risks due to immune system suppression by chemotherapy and transplantation procedure-related complications like bleeding or reactions during infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of T-cell lymphoma.

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My cancer is partially or completely responding to treatment.

Exclusion Criteria

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

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My health is too poor for standard treatments.

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I have been treated with romidepsin before.

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My cancer has spread to my brain or its coverings.

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I do not have serious heart conditions or uncontrolled high blood pressure.

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I do not have an active infection, including mold or HIV, at the time of transplantation.

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I have had a stem cell transplant from myself or a donor.

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My disease got worse during my transplant evaluation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The progression-free survival of patients

Secondary study objectives

OS 1 year after Romidespin completion

PFS 1 year after Romidespin completion

Probability of OS at 2 years post transplant

+2 more

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: high dose chemo w/asct + maintenance txtExperimental Treatment1 Intervention

High dose chemotherapy (Carmustine), VP-16 (etoposide, Vepesid®), Cytarabine (Ara-C), Melphalan (Alkeran)with autologous stem cell transplant followed by maintenance therapy with Romidepsin (Istodax)

0 / 9Eligibility criteria met