Please assess the completion status of the following clinical trial:

Trial Title: Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Study Design Characteristics:
- Allocation: None
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE2
- Number of Arms: 1.0

Eligibility Criteria:
Inclusion Criteria:~1. Diagnosis of B-cell CLL or SLL, with diagnosis established according to IWCLL criteria and documented within medical records. Patients must not have received previous therapy for CLL/SLL~2. CLL/SLL that warrants treatment consistent with accepted IWCLL criteria for initiation of therapy. Any one of the following conditions constitutes CLL/SLL that warrants treatment:~   1. Evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia, or~  2. Massive (i.e., lower edge of spleen ≥6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or~  3. Massive (i.e., ≥10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy, or~  4. Progressive lymphocytosis in the absence of infection, with an increase in blood absolute lymphocyte count (ALC) ≥50% over a 2-month period or lymphocyte doubling time of \<6 months (as long as initial ALC was ≥30,000/L), or~  5. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, or~  6. Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs occurring in the absence of evidence of infection:~   i. Unintentional weight loss of ≥10% within the previous 6 months, or~   ii. Significant fatigue (≥Grade 2), or~   iii. Fevers \>100.5°F or 38.0°C for ≥2 weeks, or~   iv. Drenching night sweats for \>1 month.~3. Adequate organ system function, defined as follows:~   1. Absolute neutrophil count (ANC) ≥ 0.5x109/L and platelet count ≥ 30x109/L~  2. Total bilirubin ≤2.5 times the upper limit of normal (ULN) unless due to Gilbert's disease~  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN if no liver involvement or ≤5 x the ULN if known liver involvement~  4. Calculated creatinine clearance \>30 mL/min (as calculated by the Cockcroft-Gault formula)~  5. Patients with PT/INR or aPTT ≤2xULN.~4. ECOG performance status ≤ 2 unless related to CLL.~5. Male or female ≥ 18 years of age.~6. Ability to swallow and retain oral medication.~7. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib and for 12 months following last dose of rituximab. (see Appendix 3 for examples)~8. Willingness and ability to comply with study and follow-up procedures, and give written informed consent.~Exclusion Criteria:~1. Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery).~   a. Systemic corticosteroid therapy started prior to study entry is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted.~2. Serologic status reflecting active hepatitis B or C infection. Patients who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.~3. Known history of HIV.~4. Known histological transformation from CLL to an aggressive lymphoma.~5. Evidence of ongoing systemic bacterial, fungal or viral infection, except localized fungal infections of skin or nails. NOTE: Patients may be receiving prophylactic antiviral or antibacterial therapies at investigator discretion.~6. Live virus vaccines within 4 weeks prior to C1D1 or during rituximab therapy.~7. History of anaphylaxis (excluding infusion related reactions) in association with previous anti-CD20 administration or acalabrutinib.~8. Any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:~   1. Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV)~  2. Uncontrolled cardiac arrhythmia (Patients with controlled atrial fibrillation/flutter are eligible)~  3. Myocardial infarction within 3 months of enrollment~  4. Angina not well-controlled by medication~  5. Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident (CVA), transient ischemic attack (TIA), angioplasty, cardiac/vascular stenting within 3 months of enrollment.~  6. Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).~  7. Any history of intracranial bleed or stroke within 6 months of first dose of study drug~  8. Patients with suspected or confirmed PML~  9. Patients with malabsorption syndrome or gastrointestinal disease that limits absorption of oral medication~9. Malignancy within 2 years of study enrollment except for adequately treated basal, squamous cell carcinoma or non-melanomatous skin cancer, carcinoma in situ of the cervix, superficial bladder cancer not treated with intravesical chemotherapy or BCG within 6 months, localized prostate cancer and PSA \<1.0 mg/dL on 2 consecutive measurements at least 3 months apart with the most recent one being within 4 weeks of study entry.~10. Patients with active uncontrolled autoimmune hemolytic anemia or ITP.~11. Inability to discontinue use of strong CYP3A inhibitors. Patients taking moderate CYP3A inhibitors or strong CYP3A inducers are eligible.~12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (eg, phenprocoumon) within 7 days of first dose of study drug.~13. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) at study entry. Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study.

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: f

Study Arms:
- Acalabrutinib and Rituximab treatment (Type: EXPERIMENTAL): Rituximab: administered 2 times weekly for 6 cycles. Initial dose day 1: 50 mg IV, Then 50 mg SQ thereafter.~Acalabrutinib: 100 mg po BID starting on day 8 of cycle 1.~* Patients who have attained a complete response who are also MRD negative at cycle 12 will undergo a BM biopsy to confirm CR and MRD negatively. If confirmed, the patient will stop therapy and be followed until disease progression.~* Patients not in a MRD negative CR, will continue acalabrutinib.~* Repeat response assessments (CTs, MRD testing in blood) will be performed at 24 cycles of therapy for those continuing on acalabrutinib. If both negative the patient will undergo a BM biopsy to confirm CR and MRD negativity. If confirmed, the patient will stop therapy and be followed until disease progression. In the absence of a CR or if MRD +, acalabrutinib may be continued until disease progression, unacceptable toxicity or physician/patient discretion.

Based on this trial design, predict the completion outcome and termination type (if applicable).