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

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen bySteven Horowitz, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to test the benefit of a chemotherapy drug called romidepsin in patients with T Cell Non-Hodgkin Lymphoma (T NHL) who have undergone autologous transplantation.

Eligibility Criteria

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.

Inclusion Criteria

I am over 16 and approved for a transplant by my doctor.

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

Stem cell collection: A minimum of 2 x 10^6 CD34+ cells must have been collected

+2 more

Exclusion Criteria

My health is too poor for standard treatments.

I have been treated with romidepsin before.

My cancer has spread to my brain or its coverings.

+5 more

Participant Groups

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.

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)

Autologous Stem Cell Transplant is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Autologous Stem Cell Transplant for: