Active, not recruitingNCT04115631Updated Sep 14, 2026

A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 2 interventional study of Acalabrutinib and Bendamustine in Liver Lymphoma and Mantle Cell Lymphoma, sponsored by ECOG-ACRIN Cancer Research Group. Active, not recruiting at 504 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by ECOG-ACRIN Cancer Research Group · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 360
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.

Read the detailed description

PRIMARY OBJECTIVE:

I. Positron mission tomography (PET)/computed tomography (CT) complete response (CR)/peripheral blood minimal residual disease (MRD) negative rate.

SECONDARY OBJECTIVES:

I. Progression-free survival at 36 months. II. Toxicity rates (incidence of grade 3/4 infections, renal and neurologic toxicities, cumulative dose of cytarabine \& acalabrutinib, dose reduction, and treatment discontinuation due to toxicity).

III. Objective response rate (ORR). IV. Overall survival at 36 months. V. Mobilization failure rate (defined as a yield \< 2 x 10\^6 CD34+ stem cells/kg with a maximum of 4 courses of apheresis).

VI. To compare PET/CT negative rate between the three arms. VII. To evaluate the association between baseline PET quantitative assessment (qPET) and MRD status at end of treatment (EOT).

VIII. To evaluate the association between the change of qPET parameters from baseline to EOT and MRD, and compare this association across all 3 arms.

IX. To determine the incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI]) in predicting MRD status at EOT.

X. To determine the prognostic value of baseline, interim and EOT PET in predicting progression-free survival (PFS).

EXPLORATORY IMAGING OBJECTIVES:

I. Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status at EOT (end of induction).

II. Explore the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status at EOT.

III. Explore the incremental prognostic value of interim qPET to Ki67 in predicting MRD status at EOT.

IV. Explore the association of interim and EOT PET with overall survival (OS).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive bendamustine intravenously (IV) on days 1 and 2 and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive rituximab IV on day 1 and cytarabine IV every 12 hours (Q12 hours) on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive acalabrutinib PO BID on days 1-7 and 22-28, rituximab IV on day 1, and cytarabine IV Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive acalabrutinib PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months until year 10.

Conditions studied

Liver Lymphoma
Mantle Cell Lymphoma

Browse trials for

Lymphoma, Mantle-Cell 783

In context

Lymphoma, Mantle-Cell

783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.

This study's enrollment of 360 is above the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.

Browse Lymphoma, Mantle-Cell studies →

Lead sponsor

ECOG-ACRIN Cancer Research Group is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 13 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma.
MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN).
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib.
Absolute neutrophil count (ANC) >= 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement:
- ANC >= 500/mcL
Platelets >= 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement:
- Platelets >= 25,000/mcL
Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised bilirubin requirements:
- Bilirubin =\< 3 x institutional ULN
Aspartate aminotransferase (AST) and alanine transaminase (ALT) =\< 2.5 x institutional ULN (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised AST/ALT requirements:
- AST/ALT =\< 5 x institutional ULN
Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (aPTT) in the absence of lupus anticoagulant) \< 2 x institutional ULN (obtained with 14 days of randomization). Patients receiving anticoagulant therapy (other than warfarin or equivalent vitamin K antagonists which are excluded), higher INR/aPTT may be permitted to enroll to this study after discussion with the primary investigator (PI).
Creatinine =\< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m\^2 (obtained with 14 days of randomization).
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class 2B or better.
Patients must have a QT interval (QTc) =\< 480 msec obtained within 14 days of randomization.
Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until 12 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months after treatment ends.
Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor.
Patients may not have received the following within 7 days prior to the first dose of study drug:
- Strong and moderate CYP3A inhibitors
- Strong and moderate CYP3A inducers
Patients are ineligible if they have any of the following:
- Malabsorption syndrome or disease significantly affecting gastrointestinal function.
- Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease).
- Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days of first dose of study drug.
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug.
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- History of severe allergic reaction attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine, cytarabine, or acalabrutinib.
Patients must be able to fulfill one of the following eligibility requirements pertaining to biospecimen availability for submission following randomization:
- Archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy is available for submission OR,
- If tumor tissue is not available, peripheral blood collected prior to initiation of protocol therapy will be submitted
  - NOTE: Biospecimens must be submitted within 60 days following randomization to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence. If peripheral blood will be submitted, Adaptive Biotechnologies should be contacted prior to patient randomization for guidance pertaining to collection and submission requirements.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 360 participants (actual)

Study arms

Experimental
Arm A (bendamustine, rituximab, cytarabine)
Patients receive bendamustine IV on days 1 and 2 and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive rituximab IV on day 1 and cytarabine IV every Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Bendamustine · Drug: Bendamustine Hydrochloride · Drug: Cytarabine · Biological: Rituximab
Experimental
Arm B (acalabrutinib, bendamustine, rituximab, cytarabine)
Patients receive PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 4, patients receive acalabrutinib PO BID on days 1-7 and 22-28, rituximab IV on day 1, and cytarabine IV Q12 hours on days 1 and 2. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Acalabrutinib · Drug: Bendamustine · Drug: Bendamustine Hydrochloride · Drug: Cytarabine · Biological: Rituximab
Experimental
Arm C (acalabrutinib, bendamustine, rituximab)
Patients receive acalabrutinib PO BID on days 1-28, bendamustine IV on days 1 and 2, and rituximab IV on day 1 or 2. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Acalabrutinib · Drug: Bendamustine · Drug: Bendamustine Hydrochloride · Biological: Rituximab

Interventions

DrugAcalabrutinib
Given PO
Also known as: ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196, Calquence
DrugBendamustine
Given IV
Also known as: SDX-105
DrugBendamustine Hydrochloride
Given IV
Also known as: Bendamustin Hydrochloride, Bendeka, Cytostasan Hydrochloride, Levact, Ribomustin, SyB L-0501, Treanda
DrugCytarabine
Given IV
Also known as: .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453
BiologicalRituximab
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima

What researchers measure

Primary outcomes

Composite of positron emission tomography (PET)/computed tomography (CT) complete response (CR) and peripheral blood (PB) minimal residual disease (MRD) negative rate
MRD status is defined as positive, negative, or indeterminate as measured from PB specimens following completion of treatment. Measures of frequencies and proportion, and location and dispersion will be used to describe categorical, and continuous variables respectively; 90% confidence intervals around these estimates will be computed. Kaplan-Meier method will be used to describe time-to-event endpoints and log-rank test to assess difference in time-to-event endpoints by levels of a categorical predictor. Cox proportional hazards (PH) regression model would be used to model the impact of baseline and other relevant variables on time-to-event endpoints.
Time frame: Up to 8 weeks post treatment

Secondary outcomes

Progression-free survival (PFS)
Time frame: From randomization to earliest of disease progression or death, assessed at 36 months
Incidence of adverse events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE). The cumulative dose of high dose cytarabine and proportion of patients that discontinued treatment due to toxicity will be assessed.
Time frame: Up to 10 years post randomization
Objective response rate (ORR)
ORR is defined as the proportion of patients achieving a best response to treatment of complete response (CR) or partial response (PR). ORR and PET/CT CR will be estimated in each treatment arm in the efficacy population, as well as among all treated patients, regardless of informative tissue status.
Time frame: Up to 10 years post randomization
Overall survival (OS)
Patients that are alive will be censored at the time of last follow-up. OS will be described using the Kaplan-Meier method and log-rank test will be used to compare survival by treatment arm.
Time frame: From randomization to death, assessed at 36 months
Mobilization failure rate
Defined as a yield \< 2 x10\^6 CD34+ stem cells/kg with a maximum of 4 course of apheresis will be summarized as a categorical variable, and compared, between treatment arms using Z- test.
Time frame: Up to 10 years post randomization

Other outcomes

PET/CT negative rate between the three arms
Time frame: Up to 10 years post randomization
PET quantitative assessment (qPET)
Will evaluate the association between baseline qPET and MRD status.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Change of qPET parameters
Will evaluate the association between the change of qPET parameters and MRD and compare this association across all 3 arms.
Time frame: Baseline to end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Incremental prognostic value of baseline qPET to standard risk markers (Mantle Cell Lymphoma International Prognostic Index [MIPI])
Will assess the incremental prognostic value of baseline to standard risk markers (MIPI) in predicting MRD status.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Interim PET status
Interim PET status both qualitatively (Deauville) and quantitatively will be correlated with MRD status. Will fit a logistic regression model to evaluate this aim with binary MRD status at end of treatment (EOT) as the response variable and interim PET status as the predictor.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Incremental prognostic value of interim qPET to standard risk markers (MIPI)
Will assess the incremental prognostic value of interim qPET to standard risk markers (MIPI) in predicting MRD status.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Incremental prognostic value of interim qPET to Ki67
Will assess the incremental prognostic value of interim qPET to Ki67 in predicting MRD status.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)
Incremental prognostic value of baseline qPET to Ki67
Will assess the incremental prognostic value of baseline qPET to Ki67 in predicting MRD status.
Time frame: At end of treatment (within 6 months after the "8 weeks post treatment" timeframe)

Study locations

504 sites

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004, United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
Kaiser Permanente-Anaheim
Anaheim, California 92806, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420, United States
Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706, United States
Kaiser Permanente-Bellflower
Bellflower, California 90706, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Kaiser Permanente-Fontana
Fontana, California 92335, United States
Kaiser Permanente - Harbor City
Harbor City, California 90710, United States
Kaiser Permanente-Irvine
Irvine, California 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027, United States
Kaiser Permanente West Los Angeles
Los Angeles, California 90034, United States
Kaiser Permanente-Ontario
Ontario, California 91761, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868, United States
Desert Regional Medical Center
Palm Springs, California 92262, United States
Kaiser Permanente - Panorama City
Panorama City, California 91402, United States
Kaiser Permanente-Riverside
Riverside, California 92505, United States
Mercy Cancer Center - Sacramento
Sacramento, California 95816, United States
Kaiser Permanente-San Diego Mission
San Diego, California 92108, United States
Kaiser Permanente-San Diego Zion
San Diego, California 92120, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401, United States
Kaiser Permanente-San Marcos
San Marcos, California 92078, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444, United States
Woodland Memorial Hospital
Woodland, California 95695, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012, United States
The Medical Center of Aurora
Aurora, Colorado 80012, United States
Boulder Community Hospital
Boulder, Colorado 80301, United States
Boulder Community Foothills Hospital
Boulder, Colorado 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado 80923, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado 80204, United States
National Jewish Health-Main Campus
Denver, Colorado 80206, United States
The Women's Imaging Center
Denver, Colorado 80209, United States
Porter Adventist Hospital
Denver, Colorado 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220, United States
Rose Medical Center
Denver, Colorado 80220, United States
Western Surgical Care
Denver, Colorado 80220, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Southwest Oncology PC
Durango, Colorado 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado 80113, United States
Swedish Medical Center
Englewood, Colorado 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado 81501, United States
North Colorado Medical Center
Greeley, Colorado 80631, United States
Good Samaritan Medical Center
Lafayette, Colorado 80026, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228, United States
Saint Anthony Hospital
Lakewood, Colorado 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120, United States
Littleton Adventist Hospital
Littleton, Colorado 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado 80124, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
McKee Medical Center
Loveland, Colorado 80539, United States
Parker Adventist Hospital
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado 80260, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado 80033, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia 20016, United States
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980, United States
Emory University Hospital Midtown
Atlanta, Georgia 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho 83617, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642, United States
Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854, United States
Kootenai Cancer Clinic
Sandpoint, Idaho 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301, United States
Saint Anthony's Health
Alton, Illinois 62002, United States

Showing the first 100 of 504 sites.

References and documents

Publications

Patel DA, Wan F, Trinkaus K, Guy DG, Edwin N, Watkins M, Bartlett NL, Cashen A, Fehniger TA, Ghobadi A, Shah NM, Kahl BS. Bendamustine/Rituximab Plus Cytarabine/Rituximab, With or Without Acalabrutinib, for the Initial Treatment of Transplant-Eligible Mantle Cell Lymphoma Patients: Pooled Data From Two Pilot Studies. Clin Lymphoma Myeloma Leuk. 2023 Jul;23(7):552-560. doi: 10.1016/j.clml.2023.04.003. Epub 2023 Apr 24. PubMed 37183115 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04115631
Lead sponsor: ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Oct 4, 2019
Start date: Dec 13, 2019
Primary completion: Dec 31, 2026 (estimated)
Completion: Dec 31, 2026 (estimated)
Last update: Sep 14, 2026

Study contacts

Nina D Wagner-Johnston

principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lymphoma, Mantle-Cell→

Other studies from this sponsor

ECOG-ACRIN Cancer Research Group

Start the discussion