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.
An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
1 other identifier
interventional
57
1 country
16
Brief Summary
This study will assess RAD001 in patients with refractory or relapsed Hodgkin Lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2009
Longer than P75 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2009
CompletedFirst Posted
Study publicly available on registry
December 1, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedResults Posted
Study results publicly available
April 6, 2016
CompletedMay 18, 2016
April 1, 2016
4.9 years
November 25, 2009
November 23, 2015
April 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR) Based on the Assessments by Investigator
ORR: % of patients whose overall disease response was a complete response (CR) or a partial response (PR) in 8 cycles CR: Complete normalization of all index nodal \& extranodal lesions: Radiological regression to normal size of all lymph nodes \& nodal masses \& complete disappearance of all lesions PR: At least a 50% decrease in the SPD of all index nodal \& extranodal lesions FDG-avid or PET positive prior to therapy: one or more PET positive at previously involved site.At least a 50% increase in the SPD of all index nodal \& extranodal lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline . Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy. Unknown (UNK): Progression not documented \& one or more of the index lesions not assessed or assessed using a different method than baseline at the time of radiologic evaluation. Each cycle was 28 days.
at screening and every threee months beginning at cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Secondary Outcomes (5)
Time to Overall Response (TTR) Per Kaplan-Meier Estimate
Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Duration of Overall Response (DoR)
Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Disease Control Rate (DCR)
Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Duration of Disease Control
Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Progression Free Survival (PFS) by Kaplan-Meier Estimate
Every three months beginning at Cycle 3 until end of treatment due to progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason
Study Arms (1)
RAD001
EXPERIMENTALPatients 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.
Interventions
Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
Eligibility Criteria
You may qualify if:
- Patients with a history of classical Hodgkin's lymphoma that has progressed after high-dose chemotherapy and Autologous Stem cell transplant and/or after gemcitabine- or vinorelbine- or vinblastine-based treatment
- 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
You may not qualify if:
- Previous treatment with mTOR inhibitors
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of California at Los Angeles UCLS School of Medicine
Los Angeles, California, 90095, United States
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
MD Anderson Cancer Center - Orlando
Orlando, Florida, 32806, United States
Emory University School of Medicine/Winship Cancer Institute Emory University Med School
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer
Chicago, Illinois, 60611, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Karmanos Cancer Institute Karmanos-1
Detroit, Michigan, 48201, United States
Mayo Clinic - Rochester Mayo Lymphoma Group
Rochester, Minnesota, 55905, United States
Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201
St Louis, Missouri, 63110, United States
New York Presbyterian Hospital Weill Cornell Med Ctr
New York, New York, 10021, United States
Duke University Medical Center Duke University Medical Ctr
Durham, North Carolina, 27710, United States
University of Tennessee Cancer Institute Univ Tennessee Cancer
Memphis, Tennessee, 38104, United States
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, 77030-4009, United States
University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4
Madison, Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 29774169DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2009
First Posted
December 1, 2009
Study Start
December 1, 2009
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
May 18, 2016
Results First Posted
April 6, 2016
Record last verified: 2016-04