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Acalabrutinib

After 18 months of acalabrutinib treatment, patients will stop acalabrutinib treatment for watch and monitor until month 60. If progression disease, patients will be re-treated with ACA at the last received dose after central reviewing of treatment criteria.

After 18 months of acalabrutinib treatment, patients will continue acalabrutinib treatment until month 60. If progression disease or unacceptable toxicity, patients will receive next line therapy at the discretion of their physicians and according to iwCLL 2018 criteria

discontinuation of acalabrutinib after 18 months in treatment-naïve CLL patients

Stop ACA

continuation of acalabrutinib at the same dose

ACA Continuation

Delphine NOLLET

Valérie ROUILLE, Pr

Aline CLAVERT, MD

Driss CHAOUI

Safia CHEBREK, Dr

Julie GAY, MD

Vincent LEVY, Pr

Xavier CAHU, Dr

Romain GUIEZE, Dr

Laurence SIMON, Dr

Lysiane MOLINA, Dr

Kamel LARIBI, Dr

Bénédicte HIVERT, Dr

Anne-Sophie MICHALLET, Dr

Thérèse AURRAN, Dr

Philippe CARASSOU, MD

Emanuelle TCHERNONOG, Dr

Bernard DRENOU, Dr

Marlene OCHMANN, Dr

Damien ROOS WEIL, Dr

Laurence SANHES, Dr

Marie-Sarah DILHUYDY, MD

Emmanuelle FERRANT, MD

Cécile TOMOWIAK, Dr

Hugo Gonzalez, Dr

Anne QUINQUENEL, Dr

Sophie DE GUIBERT, Pr

Stéphane LEPRETRE, Pr

Emilie CHALAYER, Dr

Loïc YSEBAERT, Dr

Caroline DARTIGEAS, Dr

Pierre FEUGIER, Pr

Antoine BONNET, Dr

Fatiha MERABET, Dr

Loïc Ysebaert, Pr

Romain GUIEZE, Pr

The irreversible Bruton's Tyrosine Kinase (BTK) inhibitor acalabrutinib (ACA) has potent clinical activity as a single agent in patients with treatment naive and Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL).

However, a growing body of concerns is raising regarding the unlimited administration of targeted therapy as BTKi. First, long-term treatments expose the patients to increased risk of specific adverse events (infections, bleeding events or cardiovascular problems). Second, continuous administration might also increase the risk of clonal evolution and therapeutic resistance resulting from genetic alterations such as BTK or PLCG2 mutations. Discontinuation of therapy after a fixed period is expected to prevent these events.

Rapid and deep responses yielded by ACA in elderly patients pave the way of investigating a limited 18-months period schedule. This study aims to investigate the 1-year PFS upon ACA discontinuation and efficacy of restarting ACA upon symptomatic relapse.

This multicenter, non comparative, randomized phase II trial aims at evaluating the impact of a stopping ACA strategy on PFS of CLL patients \>70 years or with coexisting comorbidities.

Patients will receive continuous Acalabrutinib (ACA) at 100 mg bid for 18 months. Dose adaptations will be made according to labels.

In case of first occurrence of grade ≥3 non-hematological toxicity, febrile grade ≥3 neutropenia or grade ≥4 hematological toxicity treatment must be stopped until recovering grade 1 or baseline state.

* 1st and second occurrence : restart at 100 mg twice daily
* 3rd occurrence : restart at 100 mg once daily
* 4th occurrence : discontinue acalabrutinib

At month 19 day 1, patients will be randomized (1:2) in two arms:

* Arm 1 = Control arm (acalabrutinib) continuing acalabrutinib until disease progression or unacceptable toxicity or
* Arm 2 = Experimental arm (watch and monitor) without ACA (see trial design).

Upon progression in the experimental arm, all patients will be re-treated with ACA at the last received dose after central reviewing of treatment criteria.

Upon progression in the control arm, patients will receive next line therapy at the discretion of their physicians and according to iwCLL 2018 criteria.

Patients will be monitored every three months until M31 then every 6 months until M60 or progression for both response and toxicity according to CTCAE v.5.

Minimal/Measurable Residual Disease (MRD) assessment will be done at month 19 day 1 in the peripheral blood.

CT-scan will be performed at baseline, then at month 19 day 1 and every 6 months within the year after randomization.

multicenter, non comparative, randomized, stop and restart

STop and Restart Acalabrutinib In fRail Patients With Previously Untreated Chronic Lymphocytic Leukemia

Time from randomization (M19 : discontinuation of acalabrutinib after of 18 months treatment) to progression (needing therapy or not) or death from any cause

French Innovative Leukemia Organisation

Spots Global Cancer Trial Database for stop aca

Every month we try and update this database with for stop aca cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stop aca

Every month we try and update this database with for stop aca cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stop aca cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.