Waldenstrom MacroglobulinemiaPhase 2NCT03679624
Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia
A Phase 2 study testing Ibrutinib and Daratumumab in people with Waldenstrom Macroglobulinemia and Waldenstrom's Disease, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinemia, Waldenstrom's Disease, Waldenström; Hypergammaglobulinemia
- What is being tested?
- Ibrutinib and Daratumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to 13 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have a diagnosis of WM and meet the requirements for active therapy as defined by the 2nd International Workshop on Waldenstrom's Macroglobulinemia
- Age ≥18 years of age
- Ibrutinib naïve or previously treated patients currently on ibrutinib with a plateau in disease response are eligible to participate.
- Ibrutinib naïve subjects may be either treatment naïve or previously treated but ibrutinib naïve to enter cohort A.
- Subjects entering cohort B must have a plateau response on ibrutinib defined as ≥ 6 months of ibrutinib treatment with 2 IgM measurements at least 2 months apart with ≤ 15% change from the previous measurement. Subjects with IgM level < 0.7 g/dL will be eligible if their IgM level increases < 0.15 g/dL over two subsequent IgM measurements as defined above.
- Subjects must have measurable disease defined by a serum IgM level ≥0.5g/dL
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- Eastern Cooperative Oncology Group performance status of 0-2
- Hematology values must be within the following limits:
- Absolute neutrophil count (ANC) ≥ 1000/mm3 independent of growth factor support for 7 days of study entry if cytopenias are due to marrow involvement.
- Platelets ≥ 50,000/mm3 independent of transfusion support within 7 days of study entry. TPO mimetics are not allowed to meet eligibility criteria.
- Hemoglobin ≥ 8g/dL, independent of transfusion support within 7 days of study entry
- Biochemical values within the following limits:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
- Total bilirubin ≤ 2 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
- Creatinine clearance (CLcr) > 25 ml/min
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin (beta-hCG) or urine beta hCG pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
- Subjects must be able to sign (or their legally-acceptable representatives must sign) an informed consent indicating that they understand the rational of the study and can participate in all study procedures.
Who cannot join
- Subject does not have a recorded IgM level recorded within 3 months prior to ibrutinib initiation.
- Subject meeting definition of disease progression while on ibrutinib. Subjects with IgM levels < 0.7gdL are given special consideration. Please see inclusion criteria for 2b.
- Subjects in cohort B experiencing ongoing non hematologic toxicities attributable to ibrutinib > Grade 1 will be excluded from study entry.
- Major surgery or a wound that has not fully healed within 4 weeks of enrollment.
- Evidence of disease transformation at time of enrollment.
- Waldenstrom's complicated by amyloidosis
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- Known central nervous system lymphoma.
- History of stroke or intracranial hemorrhage within 6 months prior to randomization.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon).
- Requires chronic treatment with strong CYP3A inhibitors. Subjects that required strong CYP3A inhibitors but completed a course of treatment can be considered for enrollment after a washout period of 14 days prior to study drug administration.
- Requires strong CYP3A inducers. Subjects that required strong CYP3A inducers but completed a course of treatment can be considered for enrollment after a washout period of 14 days prior to study drug administration.
- Patients with history of Chronic Obstructive Pulmonary Disease or Reactive Airway disease must have PFTs with FEV1 calculated. Patients with a FEV1 ≤ 50% of predicted normal will be excluded.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
- Seropositive for human immunodeficiency virus (HIV).
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- Seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
- Active malignancy not treated with curative intent within 2 years of study entry. Nonmelanotic skin cancers and cervical carcinoma in situ are excluded from this criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia
This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will comprise of patients who are currently receiving ibrutinib but whose response to treatment has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to deepen response.
Read the detailed description
This is a multi-center, two cohort Phase 2 clinical trial investigating the effectiveness of adding daratumumab to ibrutinib in WM patients. Cohort A will consist of patients who are ibrutinib naïve and appropriate for ibrutinib based treatment. Cohort B will consist of patients who have achieved a response plateau less than a complete remission (CR) on single agent ibrutinib. Subjects in Cohort A will be identified by their treating physician and eligible for enrollment if they are treatment naïve or relapsed after 1 prior therapy for WM and eligible for ibrutinib based treatment.
Subjects in Cohort B will be identified by their treating physician and eligible for enrollment if they have had at least 6 months of exposure to single agent ibrutinib and demonstrate an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed <15% from the previous mark. In Cohort B response assessment will be measured from initial IgM level prior to ibrutinib initiation.
Enrolled subjects will be prescribed commercial ibrutinib, 420mg PO daily. The investigational agent, daratumumab will be administered based on FDA approved dosing in multiple myeloma (16mg/kg) with 8 weekly induction treatments during Cycles 1 and 2, followed by every other week dosing for Cycles 3-6, then monthly dosing from Cycle 7 until Cycle 25 at which point subjects will continue with ibrutinib as monotherapy until Cycle 52 (4 years total) which is the predefined study completion for enrolled subjects at which point they will complete follow-up. Study visits and response assessments with IgM measurements will occur with each cycle for the first year then every three cycles after cycle 13. Subjects with measureable extramedullary disease will have CT scans every 6 cycles until radiographic CR. Patients will be considered evaluable for response if they completed the initial 8 weeks of daratumumab induction therapy and evaluable for toxicity if receiving one dose of daratumumab. Patients will continue on combination therapy for 2 years or until disease progression or unacceptable toxicities at which point subjects will come off trial. Patients achieving a CR after two years of combination therapy will be given an option to continue with single agent commercial ibrutinib.
- Conditions
- Waldenstrom Macroglobulinemia, Waldenstrom's Disease, Waldenström; Hypergammaglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia of Lymph Nodes, Waldenstrom's Macroglobulinaemia, Without Mention of Remission
- Being tested
- Ibrutinib, Daratumumab
- Keywords
- treatment naive, relapsed, frontline, refractory, daratumumab, ibrutinib
- Medical subject headings
- Waldenstrom Macroglobulinemia, Hypergammaglobulinemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
Also called IMBRUVICA
Ibrutinib, 420mg orally, once daily
DaratumumabDrug
Also called DARZALEX
Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Ibrutinib naive | Experimental | Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Receives: Drug: Ibrutinib; Drug: Daratumumab |
| Cohort B - Ibrutinib response plateau | Experimental | Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed <15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Receives: Drug: Ibrutinib; Drug: Daratumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event
Number of patients that experience 1 or more adverse event
Measured: 3 months
Secondary outcomes (6)
Major Response Rate in Cohort A
Number of patients in Cohort A who achieve VGPR, PR, or CR
Measured: 5 years
Deepening of Response Rate in Cohort B After Daratumumab Addition
Number of patients in Cohort B who achieve a VGPR, PR, or CR from baseline IgM prior to ibrutinib
Measured: 5 years
Duration of Response
Measured from time of first response to progression or death, measured in months.
Measured: 5 years
Time to Progression
Measured from time of study drug administration to progression, measured in months.
Measured: 5 years
Progression Free Survival
Measured from time of study drug administration to progression or death, measured in months.
Measured: 3 months
Overall Survival
Measured from time of study drug administration to death, measured in months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 Jul 2020
- Primary completion15 Sep 2020
- Study completion13 Oct 2020
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Waldenstrom MacroglobulinemiaStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- John N. Allan, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679624
- Sponsor's protocol ID
- 1708018494
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2018
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT03679624
- Acronym / sponsor ID
- 1708018494
- Conditions
- Waldenstrom Macroglobulinemia, Waldenstrom's Disease, Waldenström; Hypergammaglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia of Lymph Nodes, Waldenstrom's Macroglobulinaemia, Without Mention of Remission
- Keywords
- treatment naive, relapsed, frontline, refractory, daratumumab, ibrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC, Mayo Clinic
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and efficacy of daratumumab in combination with ibrutinib in patients with Waldenstrӧm's macroglobulinemia (WM). The study will evaluate this combination in two cohorts. Cohort A will comprise of ibrutinib naïve WM patients. Patients in this cohort may be treatment naïve or relapsed but who remain ibrutinib naïve. Cohort B will comprise of patients who are currently receiving ibrutinib but whose response to treatment has plateaued. In this cohort, daratumumab will be added on to ibrutinib in an attempt to deepen response.
Detailed description
This is a multi-center, two cohort Phase 2 clinical trial investigating the effectiveness of adding daratumumab to ibrutinib in WM patients. Cohort A will consist of patients who are ibrutinib naïve and appropriate for ibrutinib based treatment. Cohort B will consist of patients who have achieved a response plateau less than a complete remission (CR) on single agent ibrutinib. Subjects in Cohort A will be identified by their treating physician and eligible for enrollment if they are treatment naïve or relapsed after 1 prior therapy for WM and eligible for ibrutinib based treatment.
Subjects in Cohort B will be identified by their treating physician and eligible for enrollment if they have had at least 6 months of exposure to single agent ibrutinib and demonstrate an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed <15% from the previous mark. In Cohort B response assessment will be measured from initial IgM level prior to ibrutinib initiation.
Enrolled subjects will be prescribed commercial ibrutinib, 420mg PO daily. The investigational agent, daratumumab will be administered based on FDA approved dosing in multiple myeloma (16mg/kg) with 8 weekly induction treatments during Cycles 1 and 2, followed by every other week dosing for Cycles 3-6, then monthly dosing from Cycle 7 until Cycle 25 at which point subjects will continue with ibrutinib as monotherapy until Cycle 52 (4 years total) which is the predefined study completion for enrolled subjects at which point they will complete follow-up. Study visits and response assessments with IgM measurements will occur with each cycle for the first year then every three cycles after cycle 13. Subjects with measureable extramedullary disease will have CT scans every 6 cycles until radiographic CR. Patients will be considered evaluable for response if they completed the initial 8 weeks of daratumumab induction therapy and evaluable for toxicity if receiving one dose of daratumumab. Patients will continue on combination therapy for 2 years or until disease progression or unacceptable toxicities at which point subjects will come off trial. Patients achieving a CR after two years of combination therapy will be given an option to continue with single agent commercial ibrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Ibrutinib naive | Experimental | Drug: Ibrutinib, Drug: DaratumumabCohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab |
| Cohort B - Ibrutinib response plateau | Experimental | Drug: Ibrutinib, Drug: DaratumumabCohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed <15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subjects must have a diagnosis of WM and meet the requirements for active therapy as defined by the 2nd International Workshop on Waldenstrom's Macroglobulinemia
- Age ≥18 years of age
- Ibrutinib naïve or previously treated patients currently on ibrutinib with a plateau in disease response are eligible to participate.
- Subjects must have measurable disease defined by a serum IgM level ≥0.5g/dL
- Eastern Cooperative Oncology Group performance status of 0-2
Key exclusion criteria (19 listed)
- Subject does not have a recorded IgM level recorded within 3 months prior to ibrutinib initiation.
- Subject meeting definition of disease progression while on ibrutinib. Subjects with IgM levels < 0.7gdL are given special consideration. Please see inclusion criteria for 2b.
- Subjects in cohort B experiencing ongoing non hematologic toxicities attributable to ibrutinib > Grade 1 will be excluded from study entry.
- Major surgery or a wound that has not fully healed within 4 weeks of enrollment.
- Evidence of disease transformation at time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbrutinibAlso: IMBRUVICAIbrutinib, 420mg orally, once daily | Drug | Cohort A - Ibrutinib naive, Cohort B - Ibrutinib response plateau |
| DaratumumabAlso: DARZALEXDaratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months. | Drug | Cohort A - Ibrutinib naive, Cohort B - Ibrutinib response plateau |
Primary outcome
Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event
Time frame: 3 months
Number of patients that experience 1 or more adverse event
6 secondary outcomes
Major Response Rate in Cohort A
Time frame: 5 years
Deepening of Response Rate in Cohort B After Daratumumab Addition
Time frame: 5 years
Duration of Response
Time frame: 5 years
Time to Progression
Time frame: 5 years
Progression Free Survival
Time frame: 3 months
Overall Survival
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- WCM Joint Clinical Trials OfficeLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John N. Allan, M.D. principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibrutinib and Daratumumab in people with Waldenstrom Macroglobulinemia and Waldenstrom's Disease, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.