TriangleNCT00811733 · REGISTRY CONDITION SEARCH
A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-05-30
Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)
Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator
Progression-free Survival
Time to Response for Responders
Overall Survival
Clearance of Ofatumumab
Volume of Distribution at Steady State of Ofatumumab
Half-life of Ofatumumab
Cmax and Ctrough of Ofatumumab
AUC(0-tau) and AUC(0-inf) of Ofatumumab
Number of Participants With at Least One Confirmed Positive Post-ofatumumab HAHA Result
Change From Baseline in Blood Counts (CD4+, CD19+, CD50) at Month 3 After Treatment
Number of Participants With the Indicated SAEs Related to Study Drug
Number of Participants With the Indicated SAEs and Non-serious AEs Related to Study Drug
Number of Participants With the Indicated AEs Leading to Permanent Discontinuation of Study Drug and Withdrawal From Study
Number of Participants With the Indicated >=Grade 3 AEs
Number of Participants With the Indicated Infusion-related >=Grade 3 AE
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment. * Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours. * Adequate organ function. * Detectable CD20 positive of the tumor cells. * Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL. Exclusion Criteria: * Treatment of WM within the past 28 days. * Treatment with rituximab or alemtuzamab within the past 3 months. * Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years. * Current participation in another interventional clinical study. * Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception. * Active cerebrovascular disease.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
- intervention Names
- Biological: Ofatumumab
- label
- Ofatumumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Ofatumumab
- description
- Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.
- name
- Ofatumumab
- type
- BIOLOGICAL
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 37
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
- measure
- Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
- time Frame
- Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
- description
- OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
- measure
- Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
- time Frame
- Baseline and up to Study Week 16
- secondary Outcomes
- description
- Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
- measure
- Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator
- time Frame
- Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
- description
- Response criteria were based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM. CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.
- measure
- Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator
- time Frame
- Baseline and up to Study Week 16
- description
- IgM is a basic antibody that is produced by B cells. It is the first antibody to appear in response to initial exposure to antigen. IgM flare is defined as an IgM level that increases by \>25% from baseline (BL) and is associated with a response to treatment. Avoidance of IgM flare indicates the lack of an increase in IgM of \>25% from BL.
- measure
- Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)
- time Frame
- Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment
- description
- Duration of response is defined as the time from the initial response to relapse/disease progression (DP) or death. DP for CR is defined as the reappearance of the IgM protein, new signs/symptoms attributable to WM, evidence of active disease or recurrence of bone marrow involvement by lymphoplasmacytic cells, or the appearance of any new lymph node \>=1.5 centimeters on any axis. Progression for PR/MR is either a \>=25% increase in IgM from the lowest attained response value or progression of lymphadenopathy, organomegaly, cytopenias, or other clinically significant signs/symptoms caused by WM.
- measure
- Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator
- time Frame
- From baseline up to approximately 5 years
- description
- Time to disease progression is defined as the time from baseline to disease progression or death.
- measure
- Progression-free Survival
- time Frame
- From baseline up to approximately 5 years
- description
- Time to response is defined as the time from baseline to the first response date.
- measure
- Time to Response for Responders
- time Frame
- From baseline up to approximately 5 years
- description
- Overall survival is defined as the time from baseline until death due to any cause.
- measure
- Overall Survival
- time Frame
- From baseline up to approximately 5 years
- description
- Clearance (CL) is defined as the volume of plasma that is cleared of drug per unit of time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- measure
- Clearance of Ofatumumab
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
- description
- Volume of distribution at steady state (Vss) is defined as the apparent volume of distribution of the drug in the body at steady state. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- measure
- Volume of Distribution at Steady State of Ofatumumab
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
- description
- Half-life (t½) is defined as the time required for the concentration of the drug in plasma to decrease to one-half of its current value. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- measure
- Half-life of Ofatumumab
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
- description
- Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- measure
- Cmax and Ctrough of Ofatumumab
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
- description
- AUC(0-tau) is the area under the drug concentration-time curve over the dosing interval (one week). AUC(0-inf) is the area under the drug concentration-time curve from time zero extrapolated to infinite time. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
- measure
- AUC(0-tau) and AUC(0-inf) of Ofatumumab
- time Frame
- From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
Full study description
- brief Summary
- Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).
Source references
- references
- citation
- Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenstrom's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. doi: 10.1016/S2352-3026(16)30166-1. Epub 2016 Dec 1.
- pmid
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- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice