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.

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022996
• Other study ID #: CRAD001NUS65
• Status: Completed
• Phase: Phase 2
• First received: November 25, 2009
• Last updated: March 11, 2015
• Start date: December 2009
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• RAD001

• Everolimus (RAD001)
Everolimus 10 mg tablet given orally once daily.

Locations

Country	Name	City	State
United States	Emory University School of Medicine/Winship Cancer Institute Emory University Med School	Atlanta	Georgia
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer	Chicago	Illinois
United States	Wayne State University/Karmanos Cancer Institute Karmanos-1	Detroit	Michigan
United States	Duke University Medical Center Duke University Medical Ctr	Durham	North Carolina
United States	Rocky Mountain Cancer Centers RMCC - Aurora	Greenwood Village	Colorado
United States	University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)	Houston	Texas
United States	Indiana University Simon Cancer Center	Indianapolis	Indiana
United States	University of California at Los Angeles UCLS School of Medicine	Los Angeles	California
United States	University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4	Madison	Wisconsin
United States	University of Tennessee Cancer Institute Univ Tennessee Cancer	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	New York Presbyterian Hospital Weill Cornell Med Ctr	New York	New York
United States	MD Anderson Cancer Center - Orlando	Orlando	Florida
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease response to therapy with RAD001in patients with refractory/relapsed Hodgkin Lymphoma		at screening and every threee months beginning at cycle 3	No
Secondary	The amount of time to obtain a response to treatment (time to response)		Every three months beginning at Cycle 3	No
Secondary	The amount of time a patient maintains a response to treatment (Duration of response)		Every three months beginning at Cycle 3.	No
Secondary	Measure disease control rate (CR, PR, SD)		Every three months beginning at Cycle 3	No
Secondary	Evaluate progression free survival		Every three months beginning at Cycle 3	No
Secondary	Safety and tolerability of 10 mg oral daily dose of RAD001 monotherapy		Safety evaluation will include safety assessments twice per month for the first 3 months; once per month thereafter and/or more frequently if clinically indicated.	Yes

External Links

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