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An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hodgkin Lymphoma

Thank you

Trial Information

An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease response to therapy with RAD001in patients with refractory/relapsed Hodgkin Lymphoma

Outcome Time Frame:

at screening and every threee months beginning at cycle 3

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001NUS65

NCT ID:

NCT01022996

Start Date:

December 2009

Completion Date:

August 2014

Related Keywords:

  • Hodgkin Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma

Name

Location

Medical College of WisconsinMilwaukee, Wisconsin  53226
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Indiana University Simon Cancer CenterIndianapolis, Indiana  46202
MD Anderson Cancer Center - OrlandoOrlando, Florida  32806
Rocky Mountain Cancer Centers RMCC - AuroraGreenwood Village, Colorado  
MD Anderson Cancer Center/University of Texas Dept.ofMDAndersonCancerCtr(3)Houston, Texas  77030-4009
UCLA/ University of California Los Angeles UCLS School of MedicineLos Angeles, California  90095
Emory University School of Medicine/Winship Cancer Institute Emory University Med SchoolAtlanta, Georgia  30322
Northwestern University Robert H. Lurie Comp CancerChicago, Illinois  60611
Wayne State University/Karmanos Cancer Institute ;lDetroit, Michigan  48201
Mayo Clinic - Rochester Mayo Lymphoma GroupRochester, Minnesota  55905
Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201St. Louis, Missouri  63110
New York Presbyterian Hospital Weill Cornell Med CtrNew York, New York  10021
Duke University Medical Center Duke University Medical CtrDurham, North Carolina  27710
University of Tennessee Cancer Institute Univ Tennessee CancerMemphis, Tennessee  38104