Acalabrutinib and Rituximab in Previously Untreated Mantle Cell Lymphoma (CARAMEL)
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|ClinicalTrials.gov Identifier: NCT05004064|
Recruitment Status : Not yet recruiting
First Posted : August 13, 2021
Last Update Posted : November 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Mantle Cell Lymphoma||Drug: Acalabrutinib Drug: Rituximab||Phase 2|
This is a Phase II, multicentre, single arm, open label pilot study to assess the safety and efficacy of acalabrutinib in combination with rituximab for previously untreated elderly frail mantle cell lymphoma patients.
26 patients will be recruited from 12 UK centres over 18 months.
Patients will receive acalabrutinib and rituximab for up to six cycles. The cycle length is 28 days. Specifically, patients will receive acalabrutinib, orally, at a dose of 100 mg twice daily for 28 days and rituximab 375 mg/m2 intravenously on day 1 (+/-3) of each cycle.* Patients with any degree of response at the Week 12 (end of cycle 3) and Week 24 assessments (end of cycle 6) will continue with acalabrutinib monotherapy at a dose of 100 mg twice daily until disease progression, the development of unacceptable toxicity or any other reason (whichever occurs sooner).
* Note: Acalabrutinib may be administered at a dose of 100 mg od po for cycle 1 day 1-7 at the local investigator's discretion. The dose should be escalated to full dose (100 mg bd) by day 8, cycle 1 if no toxicity (see dose modification section). Rituximab may be administered subcutaneously at a flat dose of 1400 mg from cycle 2 onwards following an intravenous dose of 375 mg/m2 in cycle 1. Consider splitting the first dose of rituximab at cycle 1 in the minority of MCL patients presenting with a white cell count of >25 x 109/L. Consider splitting 25mg/m2 on Day 1 and 350mg/m2 on Day 2 of cycle 1.
All patients will be followed up for a minimum of 2 years following being registered into the trial. For patients that have been in follow-up for more than 2 years, annual survival and disease status follow-up will continue until the end of the trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Acalabrutinib and Rituximab for Elderly or Frail Patients With Previously Untreated Mantle Cell Lymphoma|
|Estimated Study Start Date :||January 1, 2023|
|Estimated Primary Completion Date :||May 31, 2026|
|Estimated Study Completion Date :||May 31, 2026|
Experimental: Acalabrutinib and rituximab
Patients with untreated mantle cell lymphoma will receive acalabrutinib and rituximab for up to six cycles. Each cycle will comprise of acalabrutinib 100mg twice daily orally for 28 days and rituximab 375mg/m2 IV on day 1 (+/1 3 days) of every cycle.
Patients will receive acalabrutinib 100mg twice daily for up to six 28 day cycles. Patients can receive 100mg once daily for cycle 1, day 1 to day 7, according to the investigator's discretion.
Patient will receive rituximab 375 mg/m2 IV on day 1 (+/- 3 days) of each cycle, for a maximum of 6 cycles
- Overall response rate [ Time Frame: 24 weeks ]To determine the efficacy of acalabrutinib in combination with rituximab in terms of disease response.
- Progression free survival [ Time Frame: From the date of first dose of acalabrutinib until the date of progression or death. Assessed up to 42 months. ]Progression free survival measured from the date of first dose of acalabrutinib until the date of first documented progression or date of death from any cause.
- Overall survival [ Time Frame: From the date of first dose of acalabrutinib until the date of death. Assessed up to 42 months. ]Overall survival measured from the date of first dose of acalabrutinib until the date of death from any cause.
- Quality of life up to 24 months [ Time Frame: At baseline, week 12, week 24, month 12 and month 24 ]The EORTC QLQ-C30 will be used to measure participant-assessed quality of life
- Incidence and frequency of grade 1-2 and 3+ adverse events seen in both treatment arms. [ Time Frame: Between the start of study treatment and 30 calendar days post last IMP administration. ]Safety and toxicity will be characterised in terms of adverse events as assessed by CTCAE v5.0. The incidence and frequency of adverse events during treatment and after treatment will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05004064
|Contact: Hayley Cartwright||0207 679 firstname.lastname@example.org|
|Contact: Emma Barsoum||0207 679 email@example.com|
|Principal Investigator:||Toby Eyre||Churchill Hospital, Oxford, United Kingdom|