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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.

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ClinicalTrials.gov Identifier: NCT01022996
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : April 6, 2016
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Everolimus (RAD001) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Study Start Date : December 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Experimental: 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.

Drug: Everolimus (RAD001)
Everolimus (RAD001) 10 mg (two 5mg tablets) given orally once daily and packed in blisters.
Other Name: RAD001




Primary Outcome Measures :
  1. Overall Response Rate (ORR) Based on the Assessments by Investigator [ Time Frame: 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 ]
    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.


Secondary Outcome Measures :
  1. Time to Overall Response (TTR) Per Kaplan-Meier Estimate [ Time Frame: 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 ]
    Time to overall response was defined as the time from the first date of treatment to the date of first documented response of CR or PR. Time to overall response is applied to patients whose best overall response is CR or PR. Patients who drop-out or did not have a response (CR or PR) will be treated as censored at the date of last adequate tumor assessment.

  2. Duration of Overall Response (DoR) [ Time Frame: 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 ]
    The duration of overall response was calculated from the date of first documented response (CR or PR) to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. This only applies to patients whose best overall response is CR or PR.

  3. Disease Control Rate (DCR) [ Time Frame: 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 ]
    The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).

  4. Duration of Disease Control [ Time Frame: 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 ]
    The duration of overall response (CR/PR) was applied only to patients whose best overall response was CR or PR. Duration of overall response was calculated from the date of the first documented response of CR or PR to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy.

  5. Progression Free Survival (PFS) by Kaplan-Meier Estimate [ Time Frame: 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) was defined as the time from the first date of treatment to the date of first documented disease progression or death due to any cause or start of a new antineoplastic therapy. An event for PFS was defined as a documented disease progression or death due to any cause or start of a new antineoplastic therapy, whichever occurred first. Cycle = 28 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Female patients who are pregnant or breastfeeding; patients who are not willing to use adequate birth control during the study and for 8 weeks after the last study treatment Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022996


Locations
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United States, California
University of California at Los Angeles UCLS School of Medicine
Los Angeles, California, United States, 90095
United States, Colorado
Rocky Mountain Cancer Centers RMCC - Aurora
Greenwood Village, Colorado, United States
United States, Florida
MD Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Emory University School of Medicine/Winship Cancer Institute Emory University Med School
Atlanta, Georgia, United States, 30322
United States, Illinois
Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute Karmanos-1
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic - Rochester Mayo Lymphoma Group
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201
St. Louis, Missouri, United States, 63110
United States, New York
New York Presbyterian Hospital Weill Cornell Med Ctr
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center Duke University Medical Ctr
Durham, North Carolina, United States, 27710
United States, Tennessee
University of Tennessee Cancer Institute Univ Tennessee Cancer
Memphis, Tennessee, United States, 38104
United States, Texas
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
Houston, Texas, United States, 77030-4009
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01022996     History of Changes
Other Study ID Numbers: CRAD001NUS65
First Posted: December 1, 2009    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: May 18, 2016
Last Verified: April 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hodgkin's Lymphoma
Hodgkin Lymphoma
Hodgkin's Disease
Hodgkin Disease
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histological type
Lymphatic Diseases
Hemic and Lymphatic Diseases
Recurrent Lymphoma
Refractory Lymphoma
Relapsed Lymphoma
Classical Hodgkin Lymphoma
Classical Hodgkin's Disease
Nodular sclerosing Hodgkin Lymphoma
Mixed-cellularity Hodgkin Lymphoma
Lymphocyte-rich Hodgkin Lymphoma
Lymphocyte depleted Hodgkin Lymphoma

Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Everolimus
Sirolimus
Vinorelbine
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators