Clinical trial NCT01022996: 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.
Official title: An Open-label, Single-arm Phase II Study of RAD001 in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Keywords: 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
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Response Rate (ORR) Based on the Assessments by Investigator
timeFrame: 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:
measure: Time to Overall Response (TTR) Per Kaplan-Meier Estimate
timeFrame: 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
measure: Duration of Overall Response (DoR)
timeFrame: 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
measure: Disease Control Rate (DCR)
timeFrame: 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
measure: Duration of Disease Control
timeFrame: 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
measure: Progression Free Survival (PFS) by Kaplan-Meier Estimate
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles UCLS School of Medicine
state: California
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers RMCC - Aurora
state: Colorado
city: Orlando
country: United States
facility: MD Anderson Cancer Center - Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine/Winship Cancer Institute Emory University Med School
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago Robert H. Lurie Comp Cancer
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute Karmanos-1
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester Mayo Lymphoma Group
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School Of Medicine-Siteman Cancer Ctr StudyCoordinator:CLBH589B2201
state: Missouri
city: New York
country: United States
facility: New York Presbyterian Hospital Weill Cornell Med Ctr
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Duke University Medical Ctr
state: North Carolina
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute Univ Tennessee Cancer
state: Tennessee
city: Houston
country: United States
facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center Clinical Science Center - H4
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.