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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (A+B)

Primary Purpose

Lymphoma, Follicular

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ofatumumab

Bendamustine infusion

Ofatumumab and Bendamustine infusions (Arm A)

Bendamustine infusion (Arm B)

About this trial

This is an interventional treatment trial for Lymphoma, Follicular focused on measuring Refractory, Safety, Efficacy, Rituximab refractory, Oncology, Ofatumumab, Bendamustine, Indolent B-cell Non- Hodgkin's Lymphoma Unresponsive, Rituximab, Rituximab-Containing Regimen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease
Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen
Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction)
ECOG Performance Status of 0, 1, or 2
Life expectancy of at least 6 months
18 years or older
Signed, written informed consent

Exclusion Criteria:

Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma
Previous allogeneic stem cell transplant
Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the past 12 months
Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two or to more than 3 vertebral bodies
High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization
Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months
Treatment with anti-CD20 monoclonal antibody within 3 months of randomization
Known CNS involvement of indolent lymphoma
Other past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
Clinically significant cardiac disease
History of significant cerebrovascular disease or event with significant symptoms
Positive serology for Hepatitis B
Current active liver or biliary disease (except Gibber's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease)
Known HIV positive
Abnormal/inadequate blood values, liver and kidney function
Current participation in other clinical study
Inability to comply with the protocol activities
Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ofatumumab and Bendamustine (Arm A)

Bendamustine (Arm B)

Arm Description

Up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and q28 days when given as monotherapy)

Up to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Secondary Outcome Measures

Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Overall Response Rate (ORR) in All Participants Per IRC

ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.

Overall Response Rate (ORR) in Participants With FL Per IRC

Overall Survival (OS) in All Participants

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Overall Survival (OS) in Participants With FL

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Time to Response in All Participants Per IRC

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Time to Response in Participants With FL Per IRC

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Duration of Response in All Participants Per IRC

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Duration of Response in Participants With FL Per IRC

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Time to Progression in All Participants Per IRC

Time from randomization until disease progression

Time to Progression in Participants With FL Per IRC

Time from randomization until disease progression

Time to Next Therapy in All Participants Per IRC

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.

Time to Next Therapy in Participants With FL Per IRC

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym

The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym

PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D

The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)

PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D

PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)

The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions

PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)

The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions

Reduction in Tumor Size

Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.

Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

This is the number of participants with change in ECOG status. Change is measured categorically by "Improvement, deterioration and No change". Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead

Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)

A summary by responders and non-responders

Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine

Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)

at scheduled visits for actual values as well as for change from baseline

Plasma Ofatumumab Concentrations

Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.

B-cell Monitoring (CD19+, CD20+)

The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.

Human Anti-chimeric Antibodies (HACA) Over Time

The number of participants with positive and negative baseline HACA results

Full Information

NCT ID

NCT01077518

First Posted

February 25, 2010

Last Updated

March 25, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01077518

Brief Title

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

Acronym

A+B

Official Title

Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated early as it did not meet the Primary efficacy objective after primary analysis.

Study Start Date

August 26, 2010 (Actual)

Primary Completion Date

January 3, 2018 (Actual)

Study Completion Date

December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Detailed Description

Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment. Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens. The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Follicular

Keywords

Refractory, Safety, Efficacy, Rituximab refractory, Oncology, Ofatumumab, Bendamustine, Indolent B-cell Non- Hodgkin's Lymphoma Unresponsive, Rituximab, Rituximab-Containing Regimen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

randomized open label bendamustine monotherapy vs. ofatumumab

Masking

None (Open Label)

Allocation

Randomized

Enrollment

346 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ofatumumab and Bendamustine (Arm A)

Arm Type

Experimental

Arm Description

Up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and q28 days when given as monotherapy)

Arm Title

Bendamustine (Arm B)

Arm Type

Active Comparator

Arm Description

Up to 8 cycles of bendamustine (120 mg/m2) on Days 1,2 every 21 days

Intervention Type

Drug

Intervention Name(s)

Ofatumumab

Other Intervention Name(s)

OMB157

Intervention Description

Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.

Intervention Type

Drug

Intervention Name(s)

Bendamustine infusion

Intervention Description

Bendamustine 100 mg/vial, injection

Intervention Type

Drug

Intervention Name(s)

Ofatumumab and Bendamustine infusions (Arm A)

Intervention Description

Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.

Intervention Type

Drug

Intervention Name(s)

Bendamustine infusion (Arm B)

Intervention Description

Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

Description

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Time Frame

From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Secondary Outcome Measure Information:

Title

Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC

Description

PFS is defined as the time interval between randomization until disease progression or death (due to any cause).

Time Frame

From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Title

Overall Response Rate (ORR) in All Participants Per IRC

Description

Time Frame

From randomization until the 217th PFS event occurred, up to about 67.5 months

Title

Overall Response Rate (ORR) in Participants With FL Per IRC

Description

Time Frame

From randomization until the 217th PFS event occurred, up to about 67.5 months

Title

Overall Survival (OS) in All Participants

Description

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Time Frame

From randomization up to about 89 months

Title

Overall Survival (OS) in Participants With FL

Description

The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.

Time Frame

From randomization up to about 89 months

Title

Time to Response in All Participants Per IRC

Description

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Time Frame

From randomization to up to 67.5 months

Title

Time to Response in Participants With FL Per IRC

Description

Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.

Time Frame

From randomization to up to 67.5 months

Title

Duration of Response in All Participants Per IRC

Description

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Time Frame

time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Title

Duration of Response in Participants With FL Per IRC

Description

Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.

Time Frame

time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Title

Time to Progression in All Participants Per IRC

Description

Time from randomization until disease progression

Time Frame

From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Title

Time to Progression in Participants With FL Per IRC

Description

Time from randomization until disease progression

Time Frame

From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Title

Time to Next Therapy in All Participants Per IRC

Description

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.

Time Frame

from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Title

Time to Next Therapy in Participants With FL Per IRC

Description

Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types

Time Frame

from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Title

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym

Description

Time Frame

administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym

Description

Time Frame

administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D

Description

Time Frame

administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D

Description

Time Frame

administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)

Description

Time Frame

administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)

Description

The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions

Time Frame

administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

Reduction in Tumor Size

Description

Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.

Time Frame

baseline, post-baseline (up to 55 months)

Title

Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status

Description

Time Frame

administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Title

Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)

Description

A summary by responders and non-responders

Time Frame

From randomization up to about 67.5 months

Title

Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine

Description

Time Frame

From randomization until the 217th PFS event occurred, up to about 67.8 months

Title

Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)

Description

at scheduled visits for actual values as well as for change from baseline

Time Frame

Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days

Title

Plasma Ofatumumab Concentrations

Description

Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.

Time Frame

C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up

Title

B-cell Monitoring (CD19+, CD20+)

Description

The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.

Time Frame

C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days

Title

Human Anti-chimeric Antibodies (HACA) Over Time

Description

The number of participants with positive and negative baseline HACA results

Time Frame

At Baseline and Cycle 1 day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease Indolent B-cell NHL that remains stable or unresponsive during or within 6 months of treatment with rituximab or a rituximab-containing regimen Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction) ECOG Performance Status of 0, 1, or 2 Life expectancy of at least 6 months 18 years or older Signed, written informed consent Exclusion Criteria: Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma Previous allogeneic stem cell transplant Previous autologous stem cell transplant, fludarabine therapy, or radioimmunotherapy in the past 12 months Previous external beam radiation therapy to the pelvis. Previous external beam radiation therapy for bony disease to the cranium, mediastinum, and axilla, or to two or to more than 3 vertebral bodies High dose steroids greater to or equal to 60 mg prednisone/day (or equivalent) within 3 months of randomization. No more than 10 mg prednisone (or equivalent) daily at the time of randomization Prior bendamustine treatment within 1 year of randomization not resulting in a CR or PR for at least 6 months Treatment with anti-CD20 monoclonal antibody within 3 months of randomization Known CNS involvement of indolent lymphoma Other past or current malignancy. Subjects free of malignancy for at least 5 years or have history of definitively treated non-melanoma skin cancer, or successfully treated in situ carcinoma, are eligible Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment Clinically significant cardiac disease History of significant cerebrovascular disease or event with significant symptoms Positive serology for Hepatitis B Current active liver or biliary disease (except Gibber's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease) Known HIV positive Abnormal/inadequate blood values, liver and kidney function Current participation in other clinical study Inability to comply with the protocol activities Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85715

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Novartis Investigative Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30341

Country

United States

Facility Name

Novartis Investigative Site

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

Novartis Investigative Site

City

Silver Spring

State/Province

Maryland

ZIP/Postal Code

21044

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Novartis Investigative Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Novartis Investigative Site

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23230

Country

United States

Facility Name

Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98108

Country

United States

Facility Name

Novartis Investigative Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Novartis Investigative Site

City

Capital Federal

State/Province

Buenos Aires

ZIP/Postal Code

C1417DTN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Novartis Investigative Site

City

Derqui, Pilar

State/Province

Buenos Aires

ZIP/Postal Code

B1629AHJ

Country

Argentina

Facility Name

Novartis Investigative Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

B1900AXI

Country

Argentina

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1437JCP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Leoben

ZIP/Postal Code

8700

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

A-5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Steyr

ZIP/Postal Code

4400

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Novartis Investigative Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Novartis Investigative Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Novartis Investigative Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

Novartis Investigative Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Novartis Investigative Site

City

Avignon cedex 9

ZIP/Postal Code

84902

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand Cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

La Roche sur Yon Cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans

ZIP/Postal Code

72015

Country

France

Facility Name

Novartis Investigative Site

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

Novartis Investigative Site

City

Nantes Cedex 2

ZIP/Postal Code

44277

Country

France

Facility Name

Novartis Investigative Site

City

Pessac cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Saint Pierre cedex

ZIP/Postal Code

97448

Country

France

Facility Name

Novartis Investigative Site

City

Saint-Denis cedex

ZIP/Postal Code

97405

Country

France

Facility Name

Novartis Investigative Site

City

Tours cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

State/Province

Bayern

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Fuerth

State/Province

Bayern

ZIP/Postal Code

90766

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80335

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Weilheim

State/Province

Bayern

ZIP/Postal Code

82362

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60488

Country

Germany

Facility Name

Novartis Investigative Site

City

Giessen

State/Province

Hessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Novartis Investigative Site

City

Hanau

State/Province

Hessen

ZIP/Postal Code

63450

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34119

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

33604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

46236

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Novartis Investigative Site

City

Goch

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

47574

Country

Germany

Facility Name

Novartis Investigative Site

City

Herford

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

32049

Country

Germany

Facility Name

Novartis Investigative Site

City

Leverkusen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51375

Country

Germany

Facility Name

Novartis Investigative Site

City

Paderborn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

33098

Country

Germany

Facility Name

Novartis Investigative Site

City

Recklinghausen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45657

Country

Germany

Facility Name

Novartis Investigative Site

City

Kaiserslautern

State/Province

Rheinland-Pfalz

ZIP/Postal Code

67655

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Neunkirchen

State/Province

Saarland

ZIP/Postal Code

66538

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12200

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28239

Country

Germany

Facility Name

Novartis Investigative Site

City

Alexandroupolis

ZIP/Postal Code

68100

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens,

ZIP/Postal Code

11 527

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

106 76

Country

Greece

Facility Name

Novartis Investigative Site

City

Haidari, Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion, Crete

ZIP/Postal Code

71201

Country

Greece

Facility Name

Novartis Investigative Site

City

Ioannina

ZIP/Postal Code

45 500

Country

Greece

Facility Name

Novartis Investigative Site

City

Piraeus

ZIP/Postal Code

18537

Country

Greece

Facility Name

Novartis Investigative Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Tuen Mun

Country

Hong Kong

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

Calabria

ZIP/Postal Code

89100

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Meldola (FC)

State/Province

Emilia-Romagna

ZIP/Postal Code

47014

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

State/Province

Piemonte

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

Puglia

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

Umbria

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Verona

State/Province

Veneto

ZIP/Postal Code

37134

Country

Italy

Facility Name

Novartis Investigative Site

City

Aichi

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

Novartis Investigative Site

City

Fukuoka

ZIP/Postal Code

810-8563

Country

Japan

Facility Name

Novartis Investigative Site

City

Hiroshima

ZIP/Postal Code

737-0023

Country

Japan

Facility Name

Novartis Investigative Site

City

Hyogo

ZIP/Postal Code

670-8520

Country

Japan

Facility Name

Novartis Investigative Site

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

Novartis Investigative Site

City

Kanagawa

ZIP/Postal Code

259-1143

Country

Japan

Facility Name

Novartis Investigative Site

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

Novartis Investigative Site

City

Okayama

ZIP/Postal Code

710-8602

Country

Japan

Facility Name

Novartis Investigative Site

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Novartis Investigative Site

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Novartis Investigative Site

City

Gdynia

Country

Poland

Facility Name

Novartis Investigative Site

City

Legnica

ZIP/Postal Code

59-200

Country

Poland

Facility Name

Novartis Investigative Site

City

Opole

ZIP/Postal Code

45-061

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-439

Country

Poland

Facility Name

Novartis Investigative Site

City

Hato Rey

ZIP/Postal Code

00919

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kaluga

ZIP/Postal Code

248007

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhniy Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Novosibirsk

ZIP/Postal Code

630087

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Penza

ZIP/Postal Code

440071

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St'Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Tula

ZIP/Postal Code

300053

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa,

ZIP/Postal Code

450054

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

833 10

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Lviv

ZIP/Postal Code

79044

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Makiivka

ZIP/Postal Code

86132

Country

Ukraine

Facility Name

Novartis Investigative Site

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL68DH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Uxbridge

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Citations:

PubMed Identifier

33973233

Citation

Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

Results Reference

derived

Learn more about this trial

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

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Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (A+B)

Lymphoma, Follicular

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial