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Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma
Phase 2 trial testing Bendamustine in Mantle Cell Lymphoma in 13 participants. Completed in 14 April 2025.
| Lead sponsor | Washington University School of Medicine |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 13 |
| Start date | 29 November 2018 |
| Primary completion | 9 February 2020 |
| Estimated completion | 14 April 2025 |
| Sites | 1 location across United States |
Washington University School of Medicine
Adults 18 to 70, any sex, with Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
-Stem cell mobilization success is defined as a yield of \>2x10\^6 CD34+ stem cells/kg with a maximum of 5 courses of apheresis
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 4 |
-Toxicity is measured using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 1 |
-For definitions of CR and PR please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 10 |
-For definitions of CR, please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 9 |
* Kaplan-Meier estimate of the median time of PFS from start of treatment to time of progression or death, whichever occurs first. * Progressive disease: * London Deauville score of 4 or 5 in individual target nodes/masses with an increase in intensity of uptake from the baseline and/or new FDG avid foci consistent with lymphoma at interim or end of treatment assessment. * New FDG avid foci of extranodal disease consistent with lymphoma. If there is concern regarding the etiology of the new lesions, biopsy or interval scan may be considered * New or recurrent FDG avid foci in the bone m
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 67.7 | 5.63 – NA |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | 9 |
* Overall survival (OS) is defined as the time from study registration to date of death due to any cause. * Kaplan-Meier method will be used for analysis.
| Group | Value | 95% CI |
|---|---|---|
| Bendamustine/Rituximab/Acalabrutinib/Cytarabine | NA | NA – NA |
Time frame: Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Bendamustine/Rituximab/Aca… |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Flu like symptoms | General disorders | — |
| Skin infection | Infections and infestations | — |
| Perirectal abscess | Infections and infestations | — |
| Infusion related reaction | General disorders | — |
| Retinal vein thrombosis | Eye disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Carcinoma of undetermined source | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Reaction | System | Bendamustine/Rituximab/Aca… |
|---|---|---|
| Lymphocyte count decreased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Infusion related reaction | General disorders | — |
| Alkaline phosphatase increased | Investigations | — |
| Creatinine increased | Investigations | — |
| Hyperuricemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Pain | General disorders | — |
| Upper respiratory infection | Infections and infestations | — |
| Bruising | Injury, poisoning and procedural complications | — |
| Blood bilirubin increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Anxiety | Psychiatric disorders | — |
| Depression | Psychiatric disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Body aches | General disorders | — |
| Fever | General disorders | — |
| Sinusitis | Infections and infestations | — |
Most-reported serious reactions: Febrile neutropenia, Flu like symptoms, Skin infection, Perirectal abscess, Infusion related reaction, Retinal vein thrombosis, Hyponatremia, Carcinoma of undetermined source.
Data from ClinicalTrials.gov NCT03623373 adverse events section.
This study is designed to evaluate the efficacy and safety of acalabrutinib plus bendamustine and rituximab followed by acalabrutinib plus cytarabine and rituximab in subjects with treatment naïve mantle cell lymphoma (MCL), as a preparation for a larger cooperative group trial with the goal of achieving a standard induction regimen for MCL in transplant eligible patients. The investigators hypothesize that the addition of acalabrutinib to BR/CR regimen will prove safe and increase the complete response (CR) rate as well as minimal residual disease (MRD) negativity pre-transplant, thus improving clinical outcomes.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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