Waldenstrom's MacroglobulinemiaPhase 1NCT04274738
A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
A Phase 1 study testing Mavorixafor and Ibrutinib in people with Waldenstrom's Macroglobulinemia, run by X4 Pharmaceuticals at 5 sites in 2 countries.
Trial summary
The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom's Macroglobulinemia
- What is being tested?
- Mavorixafor and Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Apr 2020to 31 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Participants must be able to sign informed consent
- Participants must have a clinicopathological diagnosis of WM and must meet the criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia
- Participant' WM must have confirmed MYD88L265P and CXCR4WHIM mutations
- Participants must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than or equal to (≥) 2 * the upper limit of normal (ULN)
- Participants may be treatment naïve or have received up to 3 prior treatment regimens for WM
- Participants must have an ECOG performance status of 0 or 1
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- Participants must meet the following organ and bone marrow requirements:
- Absolute neutrophil count greater than (>) 1,000/microliter (μL) ii) Platelet count ≥50,000/μL (platelet transfusion-independent) iii) Hgb ≥8 grams/deciliter (gm/dL) iv) Aspartate aminotransferase and alanine aminotransferase less than or equal to (≤) 2.5 * the ULN and serum total bilirubin ≤1.5 * the ULN, unless secondary to known Gilbert's Syndrome or hepatic infiltration by WM, in which case the total bilirubin must be ≤3 * the ULN and direct bilirubin ≤1.5 × the ULN v) Serum lipase ≤1.5 * the ULN vi) Serum creatinine ≤2 * the ULN or a creatinine clearance of ≥30 milliliters (ml)/minute based on the Cockcroft-Gault equation
- Women of child-bearing potential (WOCBP) must have a negative pregnancy test
- WOCBP who are heterosexually active and male participants with female sexual partners of childbearing potential must agree to use an effective method of contraception (for example; oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 4 weeks after the last dose of study medication, or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone a bilateral oophorectomy or who is postmenopausal, defined as the absence of menstrual periods for 12 consecutive months
- Participants must be willing and capable of complying with the requirements of the study
Who cannot join
- Participants with symptomatic hyperviscosity syndrome; participants who undergo plasmapheresis for hyperviscosity may be considered for enrollment once IgM level is under 4,000 mg/dl
- Participants who have known hypersensitivity to mavorixafor or any of its components or to ibrutinib
- Participants who have previously received a CXCR4 inhibitor or a BTK inhibitor
- Participants who are pregnant or breastfeeding
- Participants with an infection requiring intravenous antibiotics or hospitalization at the scheduled time of the first administration of protocol therapy
- Participants with glycated hemoglobin (HbA1c) >6.5%
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- Participants with central nervous system (CNS) lymphoma; participants with suspected CNS lymphoma should undergo appropriate diagnostic studies (magnetic resonance imaging, lumbar puncture) before enrollment to determine if CNS lymphoma is present
- Participants with ongoing acute clinical AEs of National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Grade >1 resulting from prior cancer therapies or participants receive prior chemotherapy within 2 weeks of initial dosing or prior autologous hematopoietic stem cell transplantation (auto-HSCT) within 6 weeks of initial dosing
- Participants with a history of, or positive serologies for, human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (participants with HBsAb positivity due to a hepatitis B virus [HBV] vaccination are eligible)
- Participants who have had within the past 6 months, the occurrence or persistence of one or more of the following medical conditions that could not be controlled with usual medical care (for example; required emergency care or hospitalization): hypertension, diabetes, unstable angina, seizure disorder, or myocardial infarction
- Participants with clinically significant cardiac disease, including congestive heart failure consistent with New York Heart Association Class 3 or 4; uncontrolled hypertension, clinically significant angina, clinically significant arrythmias including a history of atrial fibrillationin the last 2 years, corrected QT interval using Fridericia formula of >470 milliseconds (msec) or a history of prolonged QT syndrome
- Participants who have had within the past 6 months the occurrence of one or more of the following events: cerebrovascular accident, deep vein thrombosis, pulmonary embolism, hemorrhage (NCI CTCAE Grade 3 or Grade 4), or chronic liver disease (meeting criteria for Child-Pugh Class B or C)
- Participants with prior organ transplantation (prior auto-HSCT are eligible)
- Participants who have an uncontrolled bleeding disorder or require an anticoagulant at the time of study treatment
- Participants with active autoimmune disease requiring systemic steroid administration
- Participants with active second malignancies. (except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any non-hematological malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type)
- Participants who have received an investigational agent within 5 half-lives of the agent; if the half-life of the agent is unknown, participants must wait 4 weeks
- Participants who require strong or moderate inhibitors or inducers of CYP3A4 and potent P-gp inhibitors
- Participants who require medications which are classified as sensitive CYP2D6 substrates
- Participant who have received in the 2 weeks preceding the first dose of protocol treatment, any of the following agents:
- Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor ii) Systemic corticosteroids in a dose of >10 mg equivalent of prednisone daily; topical, ophthalmic, intranasal, and inhalational corticosteroids are permitted iii) Any other immunomodulating agents, including but not limited to interferon alpha, interleukin (IL)-2, mycophenolate, antibodies to tumor necrosis factor (TNF)-α, soluble TNF receptors, Janus kinase inhibitors, or IL-23 antagonists
- Participants with any other medical, personal, social, or psychiatric condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the participant or precludes the participant's participation in the study
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Mass General Hospital Cancer Center
Boston, Massachusetts, 02114
Colorado Blood Cancer Institute
Denver, Colorado, 80215
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1b Trial of Mavorixafor, an Oral CXCR4 Antagonist, in Combination With Ibrutinib in Patients With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
Read the detailed description
This is an intrapatient dose-escalation study. Three dose levels of mavorixafor will be explored: 200 milligrams (mg) once daily (QD) (dose level 1), 400 mg QD (dose level 2), and 600 mg QD (dose level 3). Ibrutinib will be administered at its labeled dose for participants with WM, 420 mg orally QD. Each treatment cycle will be 28 days.
- Conditions
- Waldenstrom's Macroglobulinemia
- Being tested
- Mavorixafor, Ibrutinib
- Medical subject headings
- Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MavorixaforDrug
Also called X4P-001
Mavorixafor capsules will be administered per dose and schedule specified in the arm.
IbrutinibDrug
Ibrutinib capsules will be administered per dose and schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Mavorixafor and Ibrutinib | Experimental | Each participants will initially receive mavorixafor at Dose Level 1 (200 mg QD) in combination with ibrutinib 420 mg. Cohort A will comprise the first 6 participants enrolled in the study that complete at least their first cycle at Dose Level 2 (400 mg QD). Cohort A participants will start at Dose Level 1 and be allowed to dose escalate after the first cycle to Dose Level 2, if no DLTs are observed during the first cycle of each participant. Cohort B will comprise the next 6 participants enrolled into the study that complete at least their 1st cycle at Dose Level 3 (600 mg QD). Cohort B participants will start at Dose Level 1 and be allowed to dose escalate up to Dose Levels 2 and 3. Cohort C will comprise the remainder of participants enrolled up to the total of 18. Cohort C participants will start at Dose Level 1 and be allowed to escalate to 400 and 600 mg after each dose level has been deemed safe by participants from Cohort A and B. Receives: Drug: Mavorixafor; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With DLTs
Measured: Cycle 1 (28 days)
Percent Change From Baseline in Immunoglobulin M (IgM) at Cycle 1
Measured: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 2
Measured: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 3
Measured: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Percent Change From Baseline in Hemoglobin (Hgb) at Cycle 1
Measured: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 2
Measured: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 3
Measured: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Cmax of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Time to Reach Cmax (Tmax) of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Tmax of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Half-Life (t1/2) of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
t1/2 of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Area Under the Concentration-Time Curve (AUC) of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
AUC of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Volume of Distribution (Vd) of Mavorixafor
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Vd of Ibrutinib
Measured: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Change From Baseline in AUC of Absolute Neutrophil Count (ANC) at Cycle 1
Measured: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 2
Measured: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 3
Measured: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 1
Measured: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 2
Measured: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 3
Measured: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Secondary outcomes (4)
Percent Change From Baseline in Serum IgM Levels Over the Time
Measured: Baseline, at each cycle throughout the study (up to approximately 2 years) (cycle length = 28 days)
Change From Baseline in Hgb at Over the Time
Measured: Baseline, at each cycle throughout the study (up to approximately 2 years) (cycle length = 28 days)
Major Response Rate
Major response rate is defined as percentage of participants with complete response + very good partial response + partial response.
Measured: From Baseline up to end of study (up to approximately 2 years)
Number of Participants With Adverse Events (AEs)
Measured: From Baseline up to end of study (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start30 Apr 2020
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Waldenstrom's MacroglobulinemiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- X4 Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274738
- Sponsor's protocol ID
- X4P-001-204
- Other IDs
- 2019-003909-95, 2019
- Status last verified
- Aug 2024
- First submitted
- 12 Feb 2020
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Trial of Mavorixafor, an Oral CXCR4 Antagonist, in Combination With Ibrutinib in Patients With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4
- ClinicalTrials.gov ID
- NCT04274738
- Acronym / sponsor ID
- X4P-001-204
- Conditions
- Waldenstrom's Macroglobulinemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- X4 PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to establish a pharmacologically active dose of mavorixafor in combination with ibrutinib based on pooled safety, clinical response, pharmacokinetic (PK) and pharmacodynamic (PD) data to select the recommended dose for a randomized registrations trial.
Detailed description
This is an intrapatient dose-escalation study. Three dose levels of mavorixafor will be explored: 200 milligrams (mg) once daily (QD) (dose level 1), 400 mg QD (dose level 2), and 600 mg QD (dose level 3). Ibrutinib will be administered at its labeled dose for participants with WM, 420 mg orally QD. Each treatment cycle will be 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mavorixafor and Ibrutinib | Experimental | Drug: Mavorixafor, Drug: IbrutinibEach participants will initially receive mavorixafor at Dose Level 1 (200 mg QD) in combination with ibrutinib 420 mg. Cohort A will comprise the first 6 participants enrolled in the study that complete at least their first cycle at Dose Level 2 (400 mg QD). Cohort A participants will start at Dose Level 1 and be allowed to dose escalate after the first cycle to Dose Level 2, if no DLTs are observed during the first cycle of each participant. Cohort B will comprise the next 6 participants enrolled into the study that complete at least their 1st cycle at Dose Level 3 (600 mg QD). Cohort B participants will start at Dose Level 1 and be allowed to dose escalate up to Dose Levels 2 and 3. Cohort C will comprise the remainder of participants enrolled up to the total of 18. Cohort C participants will start at Dose Level 1 and be allowed to escalate to 400 and 600 mg after each dose level has been deemed safe by participants from Cohort A and B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must be able to sign informed consent
- Participants must have a clinicopathological diagnosis of WM and must meet the criteria for treatment using consensus panel criteria from the Second International Workshop on Waldenstrom's Macroglobulinemia
- Participant' WM must have confirmed MYD88L265P and CXCR4WHIM mutations
- Participants must have measurable disease, defined as the presence of serum IgM with a minimum IgM level of greater than or equal to (≥) 2 * the upper limit of normal (ULN)
- Participants may be treatment naïve or have received up to 3 prior treatment regimens for WM
Key exclusion criteria (22 listed)
- Participants with symptomatic hyperviscosity syndrome; participants who undergo plasmapheresis for hyperviscosity may be considered for enrollment once IgM level is under 4,000 mg/dl
- Participants who have known hypersensitivity to mavorixafor or any of its components or to ibrutinib
- Participants who have previously received a CXCR4 inhibitor or a BTK inhibitor
- Participants who are pregnant or breastfeeding
- Participants with an infection requiring intravenous antibiotics or hospitalization at the scheduled time of the first administration of protocol therapy
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 |
|---|---|---|
| MavorixaforAlso: X4P-001Mavorixafor capsules will be administered per dose and schedule specified in the arm. | Drug | Mavorixafor and Ibrutinib |
| IbrutinibIbrutinib capsules will be administered per dose and schedule specified in the arm. | Drug | Mavorixafor and Ibrutinib |
Primary outcome
Number of Participants With DLTs
Time frame: Cycle 1 (28 days)
Percent Change From Baseline in Immunoglobulin M (IgM) at Cycle 1
Time frame: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 2
Time frame: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in IgM at Cycle 3
Time frame: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Percent Change From Baseline in Hemoglobin (Hgb) at Cycle 1
Time frame: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 2
Time frame: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Percent Change From Baseline in Hgb at Cycle 3
Time frame: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximum Observed Plasma Concentration (Cmax) of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Cmax of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Time to Reach Cmax (Tmax) of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Tmax of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Half-Life (t1/2) of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
t1/2 of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Accumulation Ratio of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Area Under the Concentration-Time Curve (AUC) of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
AUC of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Clearance of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Volume of Distribution (Vd) of Mavorixafor
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Vd of Ibrutinib
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, and 8 to 10 hours post-dose on Day 1 and Day 21 of Cycle 1, 2, and 3 (each cycle length = 28 days)
Change From Baseline in AUC of Absolute Neutrophil Count (ANC) at Cycle 1
Time frame: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 2
Time frame: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Change From Baseline in AUC of ANC at Cycle 3
Time frame: Baseline, at the end of Cycle 3 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 1
Time frame: Baseline, at the end of Cycle 1 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 2
Time frame: Baseline, at the end of Cycle 2 (cycle length = 28 days)
Maximal Change From Baseline in ANC Count at Cycle 3
Time frame: Baseline, at the end of Cycle 3 (cycle length = 28 days)
4 secondary outcomes
Percent Change From Baseline in Serum IgM Levels Over the Time
Time frame: Baseline, at each cycle throughout the study (up to approximately 2 years) (cycle length = 28 days)
Change From Baseline in Hgb at Over the Time
Time frame: Baseline, at each cycle throughout the study (up to approximately 2 years) (cycle length = 28 days)
Major Response Rate
Time frame: From Baseline up to end of study (up to approximately 2 years)
Number of Participants With Adverse Events (AEs)
Time frame: From Baseline up to end of study (up to approximately 2 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mavorixafor and Ibrutinib in people with Waldenstrom's Macroglobulinemia, run by X4 Pharmaceuticals at 5 sites in 2 countries.
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 11 inclusion and 22 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Greece. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants With DLTs (time frame: Cycle 1 (28 days)). The study lists 27 primary outcomes in all. 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 27 Aug 2024.