Study of RAD001 in Patients With Relapsed/Refractory Hodgkin Lymphoma That Has Progressed After High-dose Chemotherapy and Autologous Stem Cell Transplant and/or After Gemcitabine- or Vinorelbine- or Vinblastine-based Treatment.
NCT ID: NCT01022996
Last Updated: 2016-05-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2009-12-31
2014-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Everolimus in Combination With DHAP in Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT01453504
A Phase I Dose Escalation Study of RAD001 Administered in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
NCT00622258
Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
NCT01075321
Everolimus in Treating Patients With Lymphoma That Has Relapsed or Not Responded to Previous Treatment
NCT00436618
Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma
NCT00967044
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RAD001
Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. All patients were assigned to a daily dose of everolimus 10 mg (two 5-mg tablets), selfadministered orally and continuously from Cycle 1 Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death, or discontinuation from the study for any other reason.
A treatment cycle consisted of 28 days.
Everolimus (RAD001)
Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Everolimus (RAD001)
Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with at least one site of measurable disease measuring ≥ 2.0cm confirmed by PET and CT Scan (or MRI)
* Patients with adequate bone marrow, liver and renal function (confirmed by laboratory values)
* Patients with fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN
Exclusion Criteria
* Prior allogeneic stem cell transplant
* Chemotherapy, monoclonal antibody therapy, major surgery or treatment with other investigational drugs within 4 weeks of starting study treatment
* Another malignancy within 3 years of study entry (except adequately treated non-melanoma skin cancer and carcinoma in situ of the cervix)
* Severe and/or uncontrolled medical conditions that could affect participation in this study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California at Los Angeles UCLS School of Medicine
Los Angeles, California, United States
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
MD Anderson Cancer Center - Orlando
Orlando, Florida, United States
Emory University School of Medicine/Winship Cancer Institute Emory University Med School
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer
Chicago, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute Karmanos-1
Detroit, Michigan, United States
Mayo Clinic - Rochester Mayo Lymphoma Group
Rochester, Minnesota, United States
Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201
St Louis, Missouri, United States
New York Presbyterian Hospital Weill Cornell Med Ctr
New York, New York, United States
Duke University Medical Center Duke University Medical Ctr
Durham, North Carolina, United States
University of Tennessee Cancer Institute Univ Tennessee Cancer
Memphis, Tennessee, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States
University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Johnston PB, Pinter-Brown LC, Warsi G, White K, Ramchandren R. Phase 2 study of everolimus for relapsed or refractory classical Hodgkin lymphoma. Exp Hematol Oncol. 2018 May 11;7:12. doi: 10.1186/s40164-018-0103-z. eCollection 2018.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRAD001NUS65
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.