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Trial record 79 of 1215 for:    "Hodgkin lymphoma"

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 )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Intervention Drug: Everolimus (RAD001)
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RAD001
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 57
Completed 0
Not Completed 57
Reason Not Completed
Adverse Event             14
Withdrawal by Subject             3
Lost to Follow-up             1
Administrative problems             6
Disease Progression             32
Protocol Violation             1
Arm/Group Title RAD001
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) consisted of all patients who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
36.33  (14.101)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
33
  57.9%
Male
24
  42.1%
1.Primary Outcome
Title Overall Response Rate (ORR) Based on the Assessments by Investigator
Hide Description 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: percentage of participants
Complete response (CR) 8.8
Partial response (PR) 36.8
Response of CR or PR 45.6
2.Secondary Outcome
Title Time to Overall Response (TTR) Per Kaplan-Meier Estimate
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Median (95% Confidence Interval)
Unit of Measure: Days
NA [1] 
(79.00 to NA)
[1]
N/A = Not achieved
3.Secondary Outcome
Title Duration of Overall Response (DoR)
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: Days
350.8  (388.63)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description The disease control rate was defined as the percentage of patients with a best overall response of CR, PR or stable disease (SD).
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
80.7
(68.09 to 89.95)
5.Secondary Outcome
Title Duration of Disease Control
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: Days
321.9  (394.92)
6.Secondary Outcome
Title Progression Free Survival (PFS) by Kaplan-Meier Estimate
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RAD001
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Median (95% Confidence Interval)
Unit of Measure: Days
8.0
(5.07 to 10.96)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD001
Hide Arm/Group Description 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.
All-Cause Mortality
RAD001
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RAD001
Affected / at Risk (%)
Total   18/57 (31.58%) 
Blood and lymphatic system disorders   
Anaemia  1  2/57 (3.51%) 
Thrombocytopenia  1  1/57 (1.75%) 
Cardiac disorders   
Atrial fibrillation  1  1/57 (1.75%) 
Myocarditis  1  1/57 (1.75%) 
Pericardial effusion  1  1/57 (1.75%) 
Tachycardia  1  2/57 (3.51%) 
Gastrointestinal disorders   
Colitis  1  1/57 (1.75%) 
Diarrhoea  1  1/57 (1.75%) 
General disorders   
Drug ineffective  1  1/57 (1.75%) 
Pain  1  1/57 (1.75%) 
Pyrexia  1  3/57 (5.26%) 
Infections and infestations   
Influenza  1  1/57 (1.75%) 
Pneumonia  1  4/57 (7.02%) 
Pseudomembranous colitis  1  1/57 (1.75%) 
Respiratory tract infection  1  1/57 (1.75%) 
Upper respiratory tract infection  1  1/57 (1.75%) 
Injury, poisoning and procedural complications   
Ankle fracture  1  1/57 (1.75%) 
Investigations   
Haemoglobin decreased  1  1/57 (1.75%) 
Metabolism and nutrition disorders   
Dehydration  1  1/57 (1.75%) 
Diabetes mellitus  1  1/57 (1.75%) 
Hypercalcaemia  1  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/57 (1.75%) 
Muscular weakness  1  1/57 (1.75%) 
Pain in extremity  1  1/57 (1.75%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare  1  1/57 (1.75%) 
Nervous system disorders   
Complex regional pain syndrome  1  1/57 (1.75%) 
Nerve compression  1  1/57 (1.75%) 
Respiratory, thoracic and mediastinal disorders   
Alveolitis  1  1/57 (1.75%) 
Cough  1  1/57 (1.75%) 
Dyspnoea  1  1/57 (1.75%) 
Haemoptysis  1  1/57 (1.75%) 
Hypoxia  1  1/57 (1.75%) 
Interstitial lung disease  1  1/57 (1.75%) 
Pleural effusion  1  2/57 (3.51%) 
Pneumonitis  1  1/57 (1.75%) 
Tachypnoea  1  1/57 (1.75%) 
Vascular disorders   
Hypotension  1  2/57 (3.51%) 
Subclavian artery occlusion  1  1/57 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAD001
Affected / at Risk (%)
Total   56/57 (98.25%) 
Blood and lymphatic system disorders   
Anaemia  1  18/57 (31.58%) 
Neutropenia  1  8/57 (14.04%) 
Thrombocytopenia  1  27/57 (47.37%) 
Eye disorders   
Vision blurred  1  4/57 (7.02%) 
Gastrointestinal disorders   
Abdominal distension  1  3/57 (5.26%) 
Abdominal pain  1  9/57 (15.79%) 
Abdominal pain upper  1  4/57 (7.02%) 
Constipation  1  5/57 (8.77%) 
Diarrhoea  1  15/57 (26.32%) 
Dyspepsia  1  5/57 (8.77%) 
Mouth ulceration  1  4/57 (7.02%) 
Nausea  1  14/57 (24.56%) 
Stomatitis  1  14/57 (24.56%) 
Toothache  1  3/57 (5.26%) 
Vomiting  1  13/57 (22.81%) 
General disorders   
Chest discomfort  1  4/57 (7.02%) 
Chest pain  1  6/57 (10.53%) 
Chills  1  5/57 (8.77%) 
Fatigue  1  33/57 (57.89%) 
Localised oedema  1  3/57 (5.26%) 
Malaise  1  3/57 (5.26%) 
Mucosal inflammation  1  5/57 (8.77%) 
Oedema peripheral  1  12/57 (21.05%) 
Pain  1  7/57 (12.28%) 
Peripheral swelling  1  3/57 (5.26%) 
Pyrexia  1  18/57 (31.58%) 
Infections and infestations   
Bronchitis  1  7/57 (12.28%) 
Nasopharyngitis  1  5/57 (8.77%) 
Oral herpes  1  3/57 (5.26%) 
Pneumonia  1  4/57 (7.02%) 
Rhinitis  1  4/57 (7.02%) 
Sinusitis  1  10/57 (17.54%) 
Upper respiratory tract infection  1  14/57 (24.56%) 
Urinary tract infection  1  4/57 (7.02%) 
Injury, poisoning and procedural complications   
Contusion  1  4/57 (7.02%) 
Investigations   
Alanine aminotransferase increased  1  8/57 (14.04%) 
Aspartate aminotransferase increased  1  9/57 (15.79%) 
Blood alkaline phosphatase increased  1  9/57 (15.79%) 
Blood cholesterol increased  1  3/57 (5.26%) 
Blood glucose increased  1  3/57 (5.26%) 
Blood lactate dehydrogenase increased  1  6/57 (10.53%) 
Liver function test abnormal  1  3/57 (5.26%) 
Weight decreased  1  7/57 (12.28%) 
White blood cell count decreased  1  3/57 (5.26%) 
Metabolism and nutrition disorders   
Decreased appetite  1  7/57 (12.28%) 
Hypercholesterolaemia  1  6/57 (10.53%) 
Hyperglycaemia  1  10/57 (17.54%) 
Hypertriglyceridaemia  1  7/57 (12.28%) 
Hypocalcaemia  1  3/57 (5.26%) 
Hypokalaemia  1  6/57 (10.53%) 
Hypophosphataemia  1  7/57 (12.28%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  9/57 (15.79%) 
Back pain  1  15/57 (26.32%) 
Joint swelling  1  3/57 (5.26%) 
Muscle spasms  1  9/57 (15.79%) 
Musculoskeletal chest pain  1  5/57 (8.77%) 
Musculoskeletal pain  1  5/57 (8.77%) 
Myalgia  1  3/57 (5.26%) 
Pain in extremity  1  8/57 (14.04%) 
Nervous system disorders   
Dysgeusia  1  8/57 (14.04%) 
Headache  1  13/57 (22.81%) 
Neuropathy peripheral  1  9/57 (15.79%) 
Psychiatric disorders   
Anxiety  1  3/57 (5.26%) 
Depression  1  3/57 (5.26%) 
Insomnia  1  6/57 (10.53%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  27/57 (47.37%) 
Dyspnoea  1  17/57 (29.82%) 
Epistaxis  1  8/57 (14.04%) 
Haemoptysis  1  3/57 (5.26%) 
Nasal congestion  1  5/57 (8.77%) 
Oropharyngeal pain  1  11/57 (19.30%) 
Pleural effusion  1  4/57 (7.02%) 
Pneumonitis  1  5/57 (8.77%) 
Productive cough  1  4/57 (7.02%) 
Wheezing  1  3/57 (5.26%) 
Skin and subcutaneous tissue disorders   
Acne  1  8/57 (14.04%) 
Night sweats  1  6/57 (10.53%) 
Pruritus  1  12/57 (21.05%) 
Rash  1  22/57 (38.60%) 
Vascular disorders   
Hot flush  1  3/57 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01022996     History of Changes
Other Study ID Numbers: CRAD001NUS65
First Submitted: November 25, 2009
First Posted: December 1, 2009
Results First Submitted: November 23, 2015
Results First Posted: April 6, 2016
Last Update Posted: May 18, 2016