- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01908777
A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma
Study Overview
Status
Conditions
Detailed Description
The primary aim is to determine a preliminary estimate of the progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies.
Secondary aims include:
- Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies.
- Determine the toxicities associated with romidepsin following autologous transplantation
- Determine the probability of OS at 2 years post transplant for all patients undergoing transplant
- Characterize the effect of romidepsin on immune recovery post HDT-ASCT
- OS and PFS 1 year after Romidespin completion
Patients who receive romidepsin after transplant will be evaluable for the primary endpoint, and will be counted towards the accrual total. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced. We will also accrue a second cohort of 8 patients who are transplanted in >CR/PR2 and for high risk histologies to be analyzed for secondary endpoints only. This cohort will not be part of the primary endpoint and will be analyzed for summary statistics only. Patients who receive romidepsin after transplant will be counted towards the accrual total for Cohort 2. Any patient who does not receive romidepsin after transplant, regardless of reason, will be replaced.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- Moffitt Cancer Center
-
-
New Jersey
-
Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, United States
- Weill Cornell Medical Center
-
New York, New York, United States, 11065
- Memorial Sloan Kettering Cancer Center
-
Uniondale, New York, United States, 11553
- Memorial Sloan Kettering Nassau
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center (Data Collection Only)
-
Seattle, Washington, United States, 98109
- University of Washington (Data Collection Only)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age: Patients over age 16 who are deemed eligible for transplant by their treating physician Disease status: CR or PR required. Remission status will be assessed at the completion of induction chemotherapy and prior to enrollment on protocol.
Diagnosis: The following histologies will need to be confirmed at MSK or locally for participating sites in order to be considered for HDT-ASCT and post-transplant maintenance romidepsin:
- 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 Stem cell collection: A minimum of 2 x 106 CD34+ cells must have been collected
Laboratory test results within these ranges:
- Total bilirubin <= 1.5 x ULN
- AST (SGOT) and ALT (SGPT) <= 3 x ULN
Exclusion Criteria:
- Diagnosis: progressive disease at transplant work-up
- Prior therapy: prior autologous or allogeneic transplant
- Active and uncontrolled infection at time of transplantation including active infection with Aspergillus or other mold, or HIV infection
- Inadequate performance status/organ function defined by DLCO < 50% (adjusted for hgb), cardiac function as defined below, KPS < 60%.
- Pregnant or breast feeding. For males and females of child-producing potential, inability to use effective contraceptive methods during the study
- Prior therapy with romidepsin
- Central nervous system or meningeal involvement
Any known cardiac abnormalities such as:
- Congenital long QT syndrome
- QTc interval ≥ 500 milliseconds
- Myocardial infarction within 6 months of transplantation. Subjects with a history of myocardial infarction between 6 and 12 months prior to transplant who are asymptomatic and have had a negative cardiac risk assessment (treadmill stress test, nuclear medicine stress test, or stress echocardiogram) since the event may participate
- Other significant ECG abnormalities including 2nd degree atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min)
- Symptomatic coronary artery disease (CAD), e.g., angina Canadian Class II-IV (see Appendix 1) In any patient in whom there is doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
- An ECG recorded at screening showing evidence of cardiac ischemia (ST depression of ≥2 mm, measured from isoelectric line to the ST segment). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present
- Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions (see Appendix 2) and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI
- A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
- Hypertrophic cardiomegaly or restrictive cardiomyopathy from prior treatment or other causes
- Uncontrolled hypertension, defined as blood pressure (BP) of ≥160/95; patients who have a history of hypertension controlled by medication must be on a stable dose (for at least one month) and meet all other inclusion criteria
- Any cardiac arrhythmia requiring an anti-arrhythmic medication (excluding stable doses of beta-blockers)
- Patients taking drugs leading to significant QT prolongation within the specified wash out period (See Appendix 3: Medications That May Cause QTc Prolongation).
- Concomitant use of CYP3A4 inhibitors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: high dose chemo w/asct + maintenance txt
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)
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The progression-free survival of patients
Time Frame: 2 Years
|
The progression-free survival of patients with T NHL who receive maintenance romidepsin at 2 years post-transplant for patients transplanted in CR1 or PR1 with standard risk histologies.
|
2 Years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival for patients with high risk histologies
Time Frame: 2 Years
|
Determine PFS at 2 yrs for patients transplanted in ≥CR/PR2 or for patients with high risk histologies.
|
2 Years
|
Toxicities
Time Frame: 2 years
|
Determine the toxicities associated with romidepsin following autologous transplantation.
Toxicities will be graded on a scale of 0 to 5 as described by the NCI- Common Terminology for Adverse Events (CTCAE), version 4.0
|
2 years
|
Probability of OS at 2 years post transplant
Time Frame: 2 year post transplant
|
Determine the probability of OS at 2 years post transplant for all patients undergoing transplant
|
2 year post transplant
|
OS 1 year after Romidespin completion
Time Frame: 1 year
|
OS 1 year after Romidespin completion
|
1 year
|
PFS 1 year after Romidespin completion
Time Frame: 1 year
|
PFS 1 year after Romidespin completion
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Steven Horowitz, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, T-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Histone Deacetylase Inhibitors
- Etoposide
- Melphalan
- Cytarabine
- Carmustine
- Romidepsin
Other Study ID Numbers
- 13-020 (Fox Chase Cancer Cener)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on T Cell Non-Hodgkin Lymphoma
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRefractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma | Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma | Refractory Cutaneous T-Cell Non-Hodgkin LymphomaUnited States
-
John ReneauActive, not recruitingRecurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage III Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-Cell Non-Hodgkin Lymphoma | Primary Cutaneous Anaplastic Large Cell Lymphoma | Refractory Primary Cutaneous T-Cell Non-Hodgkin... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage II Cutaneous T-cell Non-Hodgkin LymphomaUnited States
-
National Cancer Institute (NCI)RecruitingRefractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent Transformed Non-Hodgkin Lymphoma | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous... and other conditionsUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin LymphomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedAnaplastic Large Cell Lymphoma | Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Refractory Mature T-Cell and NK-Cell Non-Hodgkin LymphomaUnited States
-
Keimyung University Dongsan Medical CenterOtsuka Pharmaceutical Co., Ltd.RecruitingLymphoma, Extranodal NK-T-Cell | T-cell Non-Hodgkin LymphomaKorea, Republic of
-
John ReneauRecruitingRecurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Recurrent Adult T-Cell Leukemia/Lymphoma | Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Refractory Adult T-Cell Leukemia/LymphomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Hodgkin Lymphoma | Refractory Hodgkin Lymphoma | Recurrent Mantle Cell Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Refractory T-Cell Non-Hodgkin Lymphoma | Recurrent B-Cell Non-Hodgkin Lymphoma | Recurrent T-Cell Non-Hodgkin Lymphoma | Refractory Mantle Cell LymphomaUnited States
-
Walter HanelRecruitingRecurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Refractory Anaplastic Large Cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | Refractory Primary Cutaneous T-Cell Non-Hodgkin... and other conditionsUnited States
Clinical Trials on High Dose Chemotherapy with Autologous Stem Cell Transplant Followed by Maintenance Therapy with Romidepsin
-
Massachusetts General HospitalDana-Farber Cancer Institute; Genentech, Inc.; Otsuka America PharmaceuticalCompletedNon-Hodgkin's Lymphoma | CNS LymphomaUnited States
-
Novartis PharmaceuticalsActive, not recruitingNon-Hodgkin LymphomaSpain, Taiwan, Australia, Belgium, Germany, Italy, Singapore, Austria, France, Switzerland, Hong Kong, United States, Netherlands, Norway, United Kingdom, Brazil, China, Japan
-
French Innovative Leukemia OrganisationAmgenCompleted
-
University of ArkansasCompletedMultiple MyelomaUnited States
-
West Japan Thoracic Oncology GroupCompleted
-
Centre Hospitalier Universitaire de NīmesCentre Hospitalier Lyon Sud; Hôpital Haut-LévêqueUnknown
-
Memorial Sloan Kettering Cancer CenterGlaxoSmithKlineCompletedMantle Cell LymphomaUnited States
-
French Innovative Leukemia OrganisationCompleted
-
Kite, A Gilead CompanyActive, not recruitingRelapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)United States, Spain, United Kingdom, Canada, Netherlands, Germany, France, Sweden, Israel, Switzerland, Belgium, Australia, Austria, Italy
-
Fondazione IRCCS Istituto Nazionale dei Tumori,...UnknownTesticular Germ Cell Tumor | Brain and Central Nervous System Tumors | Extragonadal Germ Cell TumorItaly