Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
This study is being done to understand how to treat Mantle Cell Lymphoma (MCL). The goals of treatment are to control the lymphoma with the least amount of side effects. In many cases, MCL is treated with an antibody plus chemotherapy. An antibody is a laboratory-produced substance created to attach to proteins on the cancer cells, eventually destroying them. Chemotherapy is medicine that specifically destroys cancer cells.
The purpose of this study is to find out what effects, good and/or bad, the drugs Ofatumumab and Bendamustine have on this type of cancer. Patients in this study will either receive Ofatumumab alone, or Ofatumumab combined with Bendamustine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients receiving Immunotherapy (This arm is closed) | Experimental | The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The study design will allow for an estimation of the single agent response of ofatumumab in patients at low biologic risk for immediate disease progression. |
|
| patients receiving Chemoimmunotherapy | Experimental | The proposed study is a Simon 2 stage optimal study design investigating the activity of ofatumumab alone or in conjunction with Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. The combined regimen will assess the response rates of the combined chemo- immunotherapy program in patients with need for cytoreductive therapy, or high risk for disease progression. Patients with a leukemic phase only presentation of mantle cell lymphoma generally have clinically low-risk disease, regardless of mantle cell IPI calculations. Upon reciew with the principal investigator, these patients may be stratified to the immunotherapy only arm if clinically appropriate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofatumumab (This arm is closed) | Biological | Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Single Agent Efficacy (as Determined by Response Rate) | of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks) | 2 years |
| the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine | in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved. | Up to 6 years |
| Progression Free Survival (PFS) | will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Hamlin, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ofatumumab | Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older. |
| FG001 | Ofatumumab + Bendamustine | Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. |
| 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 | Jan 3, 2017 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ofatumumab + Bendamustine | Other | Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 & 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years |
|
| 2 years |
| Remission Duration | (calculated from confirmation of CR to progression)will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR. | Up to 6 years |
| Response Duration | (calculated from confirmation of response (CR/PR) to progression. will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR. | Up to 6 years |
| Memorial Sloan Kettering Cancer Center @ Suffolk |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering West Harrison | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center | Sleepy Hollow | New York | 10591 | United States |
| FG002 | Ofatumumab Progressors | Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ofatumumab | Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older. |
| BG001 | Ofatumumab + Bendamustine | Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. |
| BG002 | Ofatumumab Progressors | Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||
| Region of Enrollment | 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 | Single Agent Efficacy (as Determined by Response Rate) | of the monoclonal antibody ofatumumab alone in low risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks) | Dual therapy arm not assessed | Posted | Count of Participants | Participants | 2 years |
|
|
| |||||||||||||||||||||||||||||||||||||||
| Primary | the Efficacy (as Determined by Response Rate) of the Combination Ofatumumab + Bendamustine | in high risk patients. Assessments prior to each cycle of immunotherapy or chemoimmunotherapy: (every 4 weeks) | Single therapy arm not assessed | Posted | Count of Participants | Participants | 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved. | Participants in Ofatumab Progressors group were included in overall survival calculations for both ofatumumab single-agent and ofatumumab + bendamustine chemotherapy groups because this group consists of participants who were originally assigned to the single treatment arm who then progressed and then received dual therapy treatment. | Posted | Median | 95% Confidence Interval | years | Up to 6 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | will be analyzed using Kaplan-Meier estimation, and logrank tests or Cox regression models when covariates are involved. | Participants in Ofatumab Progressors group were included in overall survival calculations for both ofatumumab single-agent and ofatumumab + bendamustine chemotherapy groups because this group consists of participants who were originally assigned to the single treatment arm who then progressed and then received dual therapy treatment. | Posted | Median | 95% Confidence Interval | years | 2 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Remission Duration | (calculated from confirmation of CR to progression)will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR. | Only participants considered responders were assessed | Posted | Median | Full Range | years | Up to 6 years |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Response Duration | (calculated from confirmation of response (CR/PR) to progression. will be analyzed using competing risks tools (with death as a competing risk for progression), and will be done on the subsets of patients who have CR or CR/PR. | Only participants considered responders were assessed. | Posted | Median | Full Range | years | Up to 6 years |
|
|
6 years
Not provided
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 | Ofatumumab | Ofatumumab alone for patients with MCL who are either not candidates for ASCT or aged 65 or older. | 1 | 3 | 0 | 3 | 1 | 3 |
| EG001 | Ofatumumab + Bendamustine | Ofatumumab + Bendamustine for patients with MCL who are either not candidates for ASCT or aged 65 or older. | 13 | 24 | 7 | 24 | 23 | 24 |
| EG002 | Ofatumumab Progressors | Ofatumumab alone participants who progressed and then received Ofatumumab + Bendamustine | 2 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Infection, NOS | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Malignant neoplasm, NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Infusion related reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Blurred vision | Eye disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Hamlin, MD | Memorial Sloan Kettering Cancer Center | 646-608-1667 | hamlinp@mskcc.org |
| Aug 22, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| 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 |
|---|---|
| C527517 | ofatumumab |
| D000069461 | Bendamustine Hydrochloride |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|