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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with a specific type of T-cell lymphoma.
Select...
My cancer is partially or completely responding to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The progression-free survival of patients
Secondary outcome measures
OS 1 year after Romidespin completion
PFS 1 year after Romidespin completion
Probability of OS at 2 years post transplant
+2 moreTrial 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)
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,573 Total Patients Enrolled
University of WashingtonOTHER
1,738 Previous Clinical Trials
1,844,304 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteOTHER
542 Previous Clinical Trials
135,445 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I do not have serious heart conditions or uncontrolled high blood pressure.I do not have an active infection, including mold or HIV, at the time of transplantation.I am over 16 and approved for a transplant by my doctor.I have been diagnosed with a specific type of T-cell lymphoma.I have had a stem cell transplant from myself or a donor.My disease got worse during my transplant evaluation.My cancer is partially or completely responding to treatment.
Research Study Groups:
This trial has the following groups:- Group 1: high dose chemo w/asct + maintenance txt
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the United States Food and Drug Administration sanctioned High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin?
"The safety of High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin was rated a 2 because it is currently undergoing Phase 2 trials, where limited clinical data has been collected regarding its efficacy."
Answered by AI
Are researchers currently enlisting new participants for this experiment?
"According to clinicaltrials.gov, this particular medical trial is no longer recruiting patients, despite being initially posted on July 16th 2013 and last updated August 31st 2022. However, a variety of other studies are looking for patient volunteers at the present time; 1758 active trials in total."
Answered by AI
How many sites have enrolled participants in this investigation?
"11 medical centres are actively recruiting for this research, with the most noteworthy being Fred Hutchinson Cancer Research Center (Data Collection Only) in Seattle, University of Washington (Data Collection Only) in Basking Ridge and Memoral Sloan Kettering Cancer Center in Commack. Additionally there are 8 other clinical sites involved."
Answered by AI
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