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Immunomodulatory Agent

Romidepsin for Non-Hodgkin's Lymphoma

Phase 1 & 2
Waitlist Available
Led By Steven Horwitz, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will test the hypothesis that combining these two drugs will be more effective than using either one of them alone.

Eligible Conditions
  • Non-Hodgkin's Lymphoma
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
define the maximum tolerated dose
safety and toxicity
Secondary outcome measures
assess clinical benefit rate (CBr)
assess the overall response rate (ORR)
assess the time to response (TTR)

Side effects data

From 2018 Phase 1 & 2 trial • 51 Patients • NCT01456039
100%
Dysgeusia
100%
Leukopenia
100%
Thrombocytopenia
100%
Lymphopenia
100%
Neutropenia
100%
Nausea
100%
Vomiting
100%
Pyrexia
100%
Fatigue
100%
Decreased appetite
100%
Peripheral Sensory neuropathy
67%
Diarrhoea
67%
Anaemia
67%
Lip dry
67%
Haemoglobin decreased
67%
Weight decreased
67%
Blood phosphorus increased
67%
Hypotension
67%
Insomnia
33%
Alanine aminotransferase increased
33%
Hypokalaemia
33%
Akathisia
33%
Oedema peripheral
33%
Hypocalcaemia
33%
Hyperhidrosis
33%
Vitreous Floaters
33%
Cancer Pain
33%
Biliary colic
33%
Abdominal pain upper
33%
Dental caries
33%
Gastritis
33%
Hypothermia
33%
Influenza like illness
33%
Non-cardiac chest pain
33%
Hypermagnesaemia
33%
Hyperuricaemia
33%
Blood alkaline phosphatase increased
33%
Blood urea increased
33%
Somnolence
33%
Rash macular
33%
Hypoxia
33%
Arthralgia
33%
Back Pain
33%
Musculoskeletal stiffness
33%
Osteoarthritis
33%
Periarthritis
33%
Nasopharyngitis
33%
Influenza
33%
Upper respiratory tract infection
33%
Long QT syndrome
33%
Contusion
33%
Procedural Pain
33%
Phlebitis
33%
Pollakiuria
33%
Headache
33%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Romidepsin 9mg/m^2
Phase 1: Romidepsin 14mg/m^2
Phase 2: Romidepsin 14mg/m^2
Total: Romidepsin 14mg/m^2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Romidepsin and LenalidomideExperimental Treatment2 Interventions
This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Romidepsin
2011
Completed Phase 2
~790
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

University of NebraskaOTHER
537 Previous Clinical Trials
1,143,892 Total Patients Enrolled
Biologics, Inc.Industry Sponsor
4 Previous Clinical Trials
1,496 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,560 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01755975 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Romidepsin and Lenalidomide
Non-Hodgkin's Lymphoma Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT01755975 — Phase 1 & 2
Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01755975 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathologies are Romidepsin administered to ameliorate?

"Patients suffering from multiple myeloma, relapsed and/or refractory lymphoma and chronic lymphocytic leukemia may benefit from Romidepsin."

Answered by AI

Has there been any additional research done on Romidepsin?

"The initial study of romidepsin was conducted in 2004 at the Saint Joseph Regional Medical Center-Mishawaka. As of today, 388 trials have been concluded and 280 are being actively hosted throughout Omaha, Nebraska."

Answered by AI

In what geographic areas can the clinical trial be accessed?

"The clinical trial is being conducted at University of Nebraska Medical Center in Omaha, Memorial Sloan Kettering at Basking Ridge in Basking Ridge and other 5 sites; totaling 7. The main site for this research is the renowned Memorial Sloan Kettering Cancer Centre located in New york City."

Answered by AI

Is enrollment for this experiment available at the present time?

"The recruitment period for this trial has concluded; it was originally posted on December 1st 2012 and last amended on January 3rd 2022. If you are searching for other trials, 2441 studies involving multiple myeloma and 280 featuring Romidepsin remain open to new participants."

Answered by AI

How many individuals are taking part in this trial as participants?

"This study has already stopped recruiting patients. Initially posted on the 1st of December 2012 and last edited on 3rd January 2022, it is no longer accepting participants. However, if you are seeking out alternative trials, there currently exist 2441 medical studies regarding multiple myeloma and 280 studies involving Romidepsin that are actively enrolling volunteers."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma
2012. "Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01755975.
~5 spots leftby Apr 2025
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