Active — Not RecruitingPhase 2

Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia

Canada63 participantsStarted 2021-03-02

Plain-language summary

This is a multi-centre, open label, single-arm, phase II clinical trial in untreated patients with Waldenstrom's Macroglobulinemia. Symptomatic, previously untreated patients will receive SOC bendamustine and rituximab for 6 28-day cycles. Bendamustine will be given intravenously at 90 mg/m2 on days 1 and 2 of each cycle. Rituximab will be given on day 1 of each cycle (375 mg/m2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mg/m2 intravenously for subsequent cycles (as per institutional procedures)). Concomitantly, participants will receive 100 mg of the investigational product, Acalabrutinib, orally for 1 year (365 days) at 100 mg BID.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have biopsy proven Waldenstrom's macroglobulinemia, (biopsy from within 3 months (+/- 7 days) prior to Day 1).
✓. Have not received any systemic treatment for the disease (plasmapheresis, involved field radiation or corticosteroids (for contrast enhanced studies and to acutely control disease-related symptoms or as chemotherapy premedication)) are allowed.
✓. Be willing and able to provide written informed consent for the trial.
✓. Male or female \>=18 years of age on day of signing informed consent and of any racial or ethnic group.
✓. Have at least one measurable site of disease based on Cheson Criteria (Appendix C) using standard CT imaging or a quantifiable IgM paraprotein that is two times the upper limit of normal.
✓. Have symptomatic or impending symptomatic disease or evidence of hematologic or biochemical compromise related to the lymphoma.
✓. Have a performance status of 0-2 on the ECOG Performance Scale.
✓. Demonstrate adequate organ function as defined in Table 2. Adequate organ function must be confirmed within 72 hours prior to start of treatment. Patients with abnormal liver enzymes of up to 5 times the upper limit of normal and/or reduced glomerular filtration rate (GFR) or estimated glomerular filtration rate (eGRF) of ≥ 30 mL/min/1.73 m2can be considered for enrolment.

What they're measuring

Best combined complete response (CR) and very good partial response (VGPR)

Timeframe: through study completion, an average of 1 year - cycle 7, 12 (day 1 of 28 day cycle) up to 18 months

Trial details

NCT IDNCT04624906

SponsorSunnybrook Health Sciences Centre

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Waldenstrom Macroglobulinemia trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have biopsy proven Waldenstrom's macroglobulinemia, (biopsy from within 3 months (+/- 7 days) prior to Day 1).
✓. Have not received any systemic treatment for the disease (plasmapheresis, involved field radiation or corticosteroids (for contrast enhanced studies and to acutely control disease-related symptoms or as chemotherapy premedication)) are allowed.
✓. Be willing and able to provide written informed consent for the trial.
✓. Male or female \>=18 years of age on day of signing informed consent and of any racial or ethnic group.
✓. Have at least one measurable site of disease based on Cheson Criteria (Appendix C) using standard CT imaging or a quantifiable IgM paraprotein that is two times the upper limit of normal.
✓. Have symptomatic or impending symptomatic disease or evidence of hematologic or biochemical compromise related to the lymphoma.
✓. Have a performance status of 0-2 on the ECOG Performance Scale.
✓. Demonstrate adequate organ function as defined in Table 2. Adequate organ function must be confirmed within 72 hours prior to start of treatment. Patients with abnormal liver enzymes of up to 5 times the upper limit of normal and/or reduced glomerular filtration rate (GFR) or estimated glomerular filtration rate (eGRF) of ≥ 30 mL/min/1.73 m2can be considered for enrolment.

Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria