A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom's Macroglobulinemia

Conditions

• Waldenstrom's Macroglobulinemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ulocuplumab — DRUG
  Ulocuplumab is a type of protein called an antibody that attacks CXCR4
• Ibrutinib — DRUG
  Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity

Study Details

This research study is studying Ulocuplumab combined with ibrutinib as a possible treatment for symptomatic Waldenstrom's Macroglobulinemia (WM).

Key Dates

Start date

Oct 20, 2017

Status verified

Nov 2023

Primary completion

Dec 31, 2022

Completion

Dec 31, 2022

Study Design

Enrollment

13 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1 Dose level 1: Ibrutinib + Ulocuplumab 400mg Cycle 1 and 800mg Cycles 2-6
  * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 400mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 800mg for Cycles 2-6 on Days 1 and 15.
• Experimental: Phase 1 Dose level 2: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1200mg Cycles 2-6
  * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1200mg for Cycles 2-6 on Days 1 and 15.
• Experimental: Phase 1 Dose level 3: Ibrutinib + Ulocuplumab 800mg Cycle 1 and 1600mg Cycles 2-6
  * Ibrutinib administered orally once daily for 48 cycles * Ulocuplumab administered intravenously at 800mg for Cycle 1 on Days 1, 8, 15, and 22. Ulocuplumab administered IV at 1600mg for Cycles 2-6 on Days 1 and 15.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Ulocuplumab [ Time Frame: Up to 8 weeks for each dose level ]

Locations (1)

Find similar trials in Boston, MA