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Immunologic Factors

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.

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

Everolimus (RAD001)

Novartis Pharmaceuticals

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.

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

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.

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.

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.

The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).

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.

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.

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. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.

RAD001

Age, Continuous

Sex: Female, Male

Full Analysis Set (FAS) consisted of all patients who received at least 1 dose of study drug.

Study Director

Complete response (CR)

Partial response (PR)

Response of CR or PR

Full analysis set (FAS) consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.

Overall Response Rate (ORR) Based on the Assessments by Investigator

Time to Overall Response (TTR) Per Kaplan-Meier Estimate

Full analysis set (FAS): consisted of all patients who received at least 1 dose of study drug and was the primary set for efficacy analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.	NCT01022996	Hodgkin Lymphom...	Everolimus (RAD...	18 Years -	Novartis
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.	NCT01022996	Hodgkin Lymphom...	Everolimus (RAD...	18 Years -	Novartis

Spots Global Cancer Trial Database for nodular sclerosing hodgkin lymphoma