A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Learn more about:
Related Clinical Trial
Safety & Efficacy Study of Epcoritamab in Subjects With R/R Chronic Lymphocytic Leukemia and Richter’s Syndrome ALX148, Rituximab and Lenalidomide for the Treatment of Indolent and Aggressive B-cell Non-Hodgkin Lymphoma R-EPOCH in Combination With Ibrutinib for Patients With Classical RT of CLL Phase 1 Study VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome A Study to Evaluate the Efficacy and Safety of Obinutuzumab, Ibrutinib, and Venetoclax in Patients With Richter’s Syndrome; Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia Study of Oral Administration of LP-118 in Patients With Relapsed or Refractory NHL, RT, MM, T-PLL, Acute Leukemia (AML, ALL), MDS, MDS/MPN, and MF Ipilimumab, Ibrutinib, and Nivolumab for the Treatment of Chronic Lymphocytic Leukemia and Richter Transformation Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter’s Transformation Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma Venetoclax in Combination With Ublituximab and Umbralisib (TGR-1202) in Patients With Relapsed or Refractory CLL/SLL Ex Vivo-activated Autologous Lymph Node Lymphocytes in Treating Patients With Chronic Lymphocytic Leukemia Allogeneic Stem Cell Transplant for CLL Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin’s Lymphomas Atezolizumab, Gemcitabine, Oxaliplatin, and Rituximab in Treating Patients With Relapsed or Refractory Transformed Diffuse Large B-Cell Lymphoma Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma Sotrastaurin Acetate in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia, Prolymphocytic Leukemia, or Richter’s Transformation Registry of the German CLL Study Group Nivolumab and Ibrutinib in Treating Patients With Relapsed, Refractory, or High-Risk Untreated Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Richter Transformation ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies Study of Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) With Ofatumumab in Patients With Richter’s Syndrome PNT2258 for Treatment of Patients With Richter’s Transformation (Brighton) Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter’s Transformation Efficacy and Safety of Zanubrutinib Plus Tislelizumab for Treatment of Patients With Richter Transformation BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation Oxaliplatin, Fludarabine, Cytarabine, and Rituximab in Patients With Richter’s Transformation and Leukemias Obinutuzumab Containing Conditioning Regimen for Patients With Poor Risk CLL or Richter`s Transformation Requiring Allogeneic Stem Cell Transplantation Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170) Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS Study of Blinatumomab in Richter Transformation Genomic and Proteomic Study of Richter Syndrome (CGPSR) CRC043: A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R for Patients With Richter’s Syndrome Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter’s Transformation or Richter’s Syndrome Patients Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter’s Syndrome A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter’s Syndrome Selinexor in Initial or Refractory and/or Relapsed Richter’s Transformation

Brief Title

A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Official Title

A Phase 1/2 Proof-of-Concept Study of the Combination of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies

Brief Summary

      This study evaluates the safety of acalabrutinib and vistusertib when taken in combination.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs)


Condition

DLBCL

Intervention

acalabrutinib

Study Arms / Comparison Groups

 Part 1 continuous dose for vistusertib
Description:  acalabrutinib daily + vistusertib daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

June 29, 2017

Completion Date

November 20, 2019

Primary Completion Date

November 20, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as documented
             by medical records and with histology based on criteria established by The World
             Health Organization (WHO):

               -  If a subject has de novo DLBCL, the diagnosis is confirmed by biopsy and is
                  immunohistologically characterized as de novo germinal center B-cell-like (GCB)
                  DLBCL or de novo non-GCB DLBCL.

               -  If the subjects has Richter's Syndrome (RS), the diagnosis is confirmed by biopsy
                  and is immunohistologically characterized as transformation to DLBCL.

               -  If the subjects has transformed DLBCL, the diagnosis is confirmed by biopsy and
                  is immunohistologically characterized as transformation to DLBCL from indolent
                  lymphoma (eg, follicular lymphoma).

          2. Men and women ≥18 years of age.

          3. Prior treatment for lymphoid malignancy:

               -  If the subject has DLBCL, there is no curative option with conventional therapy
                  and the prior treatment included ≥ 1 prior combination chemoimmunotherapy
                  regimen.

               -  If the subject has RS, the subject must have had ≥1 prior treatment with a
                  combination chemoimmunotherapy regimen.

          4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.

          5. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
             malignancy (defined as the presence of a ≥1.5 cm lesion, as measured in the longest
             dimension by computed tomography [CT] scan).

        Exclusion Criteria:

          1. As judged by the Investigator, any evidence of severe or uncontrolled systemic disease
             (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse,
             parenchymal lung disease]), or current unstable or uncompensated respiratory or
             cardiac conditions, or uncontrolled hypertension, history of, or active, bleeding
             diatheses (eg, hemophilia or von Willebrand disease) or uncontrolled active systemic
             fungal, bacterial, viral, or other infection (defined as exhibiting ongoing
             signs/symptoms related to the infection and without improvement, despite appropriate
             antibiotics or other treatment), or intravenous anti-infective treatment within 2
             weeks before first dose of study drug.

          2. Diagnosis of PMBCL.

          3. Current refractory nausea and vomiting, malabsorption syndrome, disease significantly
             affecting gastrointestinal (GI) function, resection of the stomach, extensive small
             bowel resection that is likely to affect absorption, symptomatic inflammatory bowel
             disease, partial or complete bowel obstruction, or gastric restrictions and bariatric
             surgery, such as gastric bypass.

          4. History of central nervous system (CNS) lymphoma, leptomeningeal disease or spinal
             cord compression.

          5. Any clinically significant pre-existing severe renal disease (eg, glomerulonephritis,
             nephritic syndrome, Fanconi Syndrome or renal tubular acidosis) or high risk of
             developing severe renal impairment.

          6. Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline
             (left ventricular ejection fraction [LVEF] <40% and shortening fraction <15%).
             Appropriate correction to be used, if a MUGA is performed.

          7. Mean resting corrected QT interval (QTc) calculated using Fridericia's formula (QTcF)
             >450 msec obtained from 3 electrocardiograms (ECGs); family or personal history of
             long or short QT syndrome; Brugada syndrome or known history of QTc prolongation or
             torsade de pointes within 12 months of the subject entering the study.
      

Gender

All

Ages

18 Years - 130 Years

Accepts Healthy Volunteers

No

Contacts

Acerta Clinical Trials, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03205046

Organization ID

ACE-LY-110


Responsible Party

Sponsor

Study Sponsor

Acerta Pharma BV


Study Sponsor

Acerta Clinical Trials, Study Director, 1-888-292-9613; [email protected]


Verification Date

December 2020