Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma
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ClinicalTrials.gov Identifier: NCT01239394 |
Recruitment Status :
Completed
First Posted : November 11, 2010
Results First Posted : March 17, 2017
Last Update Posted : October 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Follicular Lymphoma Marginal Zone Lymphoma Small Lymphocytic Lymphoma | Drug: ofatumumab | Phase 2 |
- Participants will receive ofatumumab once a week for 8 weeks by intravenous infusion (Days 1, 8, 15, 22, 29, 36, 43, and 50).
- Participants will be seen weekly during the 8 week treatment period and will have the following tests and procedures performed: Blood tests, performance status and physical examination.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial Ofatumumab for Initial Systemic Treatment of Indolent B-cell Lymphoma |
Actual Study Start Date : | December 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2015 |
Arm | Intervention/treatment |
---|---|
ofatumumab
single-arm, open-label, interventional
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Drug: ofatumumab
Weekly infusion for 8 weeks
Other Names:
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- Efficacy: Complete Response Rate (CRR) [ Time Frame: 1-month post-treatment ]
Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by complete response rate (CRR).
Complete response = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5 cm in greatest diameter)
- Overall Response Rate (ORR) [ Time Frame: 1-month post-treatment ]
Evaluate clinical efficacy of ofatumumab in previously untreated indolent B-cell lymphomas, as measured by overall response rate (ORR).
Overall response = Complete response (CR) + Partial response (PR) CR = all previously enlarged fluorodeoxyglucose (FDG)-avid or positron emission tomography (PET)-positive lymph nodes regressed to normal size (<=1.5cm in greatest diameter) PR = >=50% decrease in SPD of up to six largest dominant masses, no increase in size of other nodes; FDG avid or PET positive before therapy, one or more nodes PET positive at previously involved site, or variably FDG avid or PET negative with regression at CT
- Progression-free Survival (PFS) [ Time Frame: 12 months ]Percentage of patients with progression-free survival during 12 months post-treatment progression-free survival: patients live with the disease, but it does not get worse
- Toxicity: Infusion Reactions, Grade 3-4 Infections, and Neutropenia [ Time Frame: 2 years ]Evaluate safety of ofatumumab monotherapy in this patient population Toxicities are graded 1 (mild), 2 (moderate), 3 (severe), and 4 (life-threatening)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed indolent CD20+B-cell NHL of the following histologies: follicular lymphoma, grades 1-2; Marginal zone lymphoma (extranodal, nodal or splenic); small lymphocytic lymphoma; low-grade B-cell lymphoma not otherwise specified with CD20+ expression
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as 20mm or greater CT scan or MRI
- No previous chemotherapy, antibody therapy or radioimmunotherapy for this disease. Patients previously treated with external beam radiation alone are eligible
- 18 years of age or older
- Life expectancy of greater than 3 months
- ECOG Performance status of 0, 1 or 2
- Organ function as described in the protocol
- Women of child-bearing potential and men must agree so use adequate contraception prior to study entry and for the duration of study participation
Exclusion Criteria:
- Prior chemotherapy, antibody therapy or radioimmunotherapy for lymphoma
- Participants may not be receiving any other investigational agent
- Participants with known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab
- Prior exposure to ofatumumab or other targeted anti-CD20 therapies including rituximab
- Known HIV positivity
- Positive serology for Hepatitis B
- Positive serology for Hepatitis C
- Participants who are candidates for curative radiotherapy, unless radiation therapy is considered too toxic (as in abdominal disease), or is refused by the patient
- New York Heart Association Classification III of IV heart disease
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection that is not optimally treated with antibiotics, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women
- History of a different malignancy are ineligible except for the following circumstances: Individuals with a history of other malignancy are eligible if they have been disease-free for at least one year and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible even if diagnosed and treated within the past 1 year: localized prostate cancer, prostate cancer with elevated PSA but no measurable disease on CT scans or bone scan, cervical cancer in situ, breast ductal carcinoma in situ and non-melanoma skin cancers.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01239394
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Jeremy S. Abramson, MD | Massachusetts General Hospital |
Responsible Party: | Jeremy Abramson, MD, Director, Lymphoma Program, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01239394 |
Other Study ID Numbers: |
10-271 |
First Posted: | November 11, 2010 Key Record Dates |
Results First Posted: | March 17, 2017 |
Last Update Posted: | October 18, 2017 |
Last Verified: | September 2017 |
NHL ofatumumab |
Lymphoma Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Lymphoma, B-Cell Leukemia, B-Cell Leukemia, Lymphoid Leukemia Hematologic Diseases Chronic Disease Disease Attributes Pathologic Processes Ofatumumab Antineoplastic Agents |