Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NA_00067315 | Other Identifier | JHMIRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This research is being done to determine if combining an investigational drug called Everolimus with Rituximab can reduce the risk of your cancer from returning after high dose chemotherapy.
Everolimus is a pill that interferes with lymphoma cell growth by blocking a cellular pathway important in causing cancer cells to grow, called mTor. Rituximab is an intravenous medication that specifically attacks a protein commonly found on lymphoma cells called CD20.
Rituximab is already widely used to treat multiple forms of lymphoma. Moreover, continuing rituximab after the completion of chemotherapy is already commonly used to help patients stay in remission longer. Everolimus has been shown in many types of relapsed lymphoma to decrease the size of lymph nodes by itself. Everolimus is approved by the Food and Drug Administration (FDA) for the treatment of advanced kidney cancer and subependymal giant cell astocytoma. It is not approved for use in lymphoma. The use of everolimus in this research study is investigational. The word "investigational" means that everolimus is not approved for marketing by the Food and Drug Administration (FDA). The FDA is allowing the use of everolimus in this study.
The combination of everolimus and rituximab for 1 year after high dose therapy is also new. We believe the combination of these medications right after your chemotherapy will be more effective in attacking your remaining cancer before they have time to re-grow.
The usual treatment of lymphoma after high-dose chemotherapy is observation. After your body has fully recovered from the effects of the chemotherapy, you will receive everolimus daily for one year and IV rituximab four times during that year.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Everolimus and Rituximab | Experimental | Everolimus daily for one year and IV rituximab four times during that year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug | The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Assessed by Avoidance of Grade 3-4 Adverse Events | Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0. | Up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival (EFS) | Percentage of participants alive without disease progression. As defined by Cheson criteria, disease progression is a new lesion or >= 50% increase in the size of previously identified sites of disease. EFS was estimated using Kaplan-Meier survival analysis. | 2.5 years |
| Percentage Change in the Frequency of Circulating Cancer Cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Patient who have previously received an mTor inhibitor
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Gladstone, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29234922 | Result | Schoch LK, Asiama A, Zahurak M, Shanbhag S, Hurtt J, Sawyer K, Swinnen LJ, Wagner-Johnston N, Jones RJ, Ambinder RF, Gladstone DE. Pharmacokinetically-targeted dosed everolimus maintenance therapy in lymphoma patients. Cancer Chemother Pharmacol. 2018 Feb;81(2):347-354. doi: 10.1007/s00280-017-3499-y. Epub 2017 Dec 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
7 participants were screen failures.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Everolimus and Rituximab | Everolimus daily for one year and IV rituximab four times during that year. Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm. Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Rituximab | Biological | 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions) |
|
|
Percentage change in circulating cancer cells between baseline and each timepoint noted below. |
| Baseline, 1 year, 2 years and 3 years |
| Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied | Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below. | 1 year, 2 years, and 3 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Everolimus and Rituximab | Everolimus daily for one year and IV rituximab four times during that year. Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm. Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Number of Prior Therapies | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety as Assessed by Avoidance of Grade 3-4 Adverse Events | Number of participants who did not experience at least one grade 3-4 adverse event by CTCAE 4.0. | Posted | Count of Participants | Participants | Up to 3 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Event Free Survival (EFS) | Percentage of participants alive without disease progression. As defined by Cheson criteria, disease progression is a new lesion or >= 50% increase in the size of previously identified sites of disease. EFS was estimated using Kaplan-Meier survival analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 2.5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage Change in the Frequency of Circulating Cancer Cells | Percentage change in circulating cancer cells between baseline and each timepoint noted below. | Data was not collected. | Posted | Baseline, 1 year, 2 years and 3 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage Change in Cancer Cells When mTOR Kinase Inhibition is Applied | Percentage change in cancer cells when mTOR inhibition is applied in the laboratory. Samples from participants will be evaluated at each timepoint noted below. | Data was not collected. | Posted | 1 year, 2 years, and 3 years |
|
|
Up to 3 years
Adverse events were assessed every 2 weeks for the first 2 months, monthly for the remainder of the first year, every 90 days for the second year, and every 6 months for the third year. Per protocol, all adverse events were collected for the first 13 participants. Only grade 3-4 and all serious adverse events were collected for the remaining participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Everolimus and Rituximab | Everolimus daily for one year and IV rituximab four times during that year. Everolimus: The initial dose of everolimus will be 2.5mg orally daily for a total of one year to maintain a target trough concentration between 3-15 ng/mL. Previously the study allowed for starting doses of 5mg and 10mg; the starting dose was reduced in subsequent amendments due to a high incidence of dose reductions. 2.5mg was the most frequent daily dose for all patients, and the entire population was analyzed as one arm. Rituximab: 375mg/m2 day +1 and then every 90 days for 1 year (a total of 4 infusions) | 0 | 49 | 13 | 49 | 47 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| MRSA | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Retinal tear | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Zoster | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Skin lesions | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertriglyceridemia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutropenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pain - throat | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thrombocytopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Gladstone, MD | Johns Hopkins University | 4109558781 | dgladst1@jhmi.edu |
| Oct 18, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Four Prior Therapies |
|
|