A Study of Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mavorixafor — DRUG
  Mavorixafor capsules will be administered per dose and schedule specified in the arm.
• Ibrutinib — DRUG
  Ibrutinib capsules will be administered per dose and schedule specified in the arm.

Study Details

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.

Key Dates

Start date

Apr 30, 2020

Status verified

Aug 2024

Primary completion

Oct 31, 2022

Completion

Oct 31, 2022

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Mavorixafor and Ibrutinib
  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.

Primary Outcome Measure

Number of Participants With DLTs [ Time Frame: Cycle 1 (28 days) ]

Locations (4)

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