Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter’s Syndrome

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

Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

Official Title

Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome

Brief Summary

      The purpose of the study is to investigate whether combination of obinutuzumab, lenalidomide,
      and high dose methylprednisolone in the treatment of Richter's Syndrome. The study will
      evaluate whether this regimen can reduce the amount of cancerous cells in your body. All of
      these agents are approved by the FDA Obinutuzumab is a protein molecule manufactured from a
      single cell population, has been approved by the Food and Drug Administration (FDA) for the
      treatment of CLL of SLL. Lenalidomide is for the treatment of patients with other blood
      cancers. Methylprednisolone is a type of steroid, and it is used in a wide variety of medical
      conditions. These agents and the combination of these agents are not approved for the
      treatment of Richter's Syndrome and are considered experimental.
    

Detailed Description

      This is a phase I trial to determine the safety and tolerability of the combination of
      obinutuzumab, lenalidomide, and HDMP for patients with RS. There is not a standard of care
      for patients with Richter's Syndrome (RS). Ten patients will be enrolled with RS diagnosed by
      histology or flow cytometry and CLL, regardless of prior treatment for either condition.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety and tolerability of the combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in treatments with Richter's Syndrome (RS) measured Via Adverse Events

Secondary Outcome

 Overall response rate of RS and CLL

Condition

Richter's Syndrome

Intervention

Obinutuzumab

Study Arms / Comparison Groups

 obinutuzumab, lenalidomide, and HDMP
Description:  

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

10

Start Date

December 20, 2017

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Histologic diagnosis of Richter's Syndrome (RS)

          -  No requirement nor restriction for prior therapy or stage

          -  Measurable disease: may include FDG avid lesion, lymph node greater than 1.5 cm in
             greatest diameter, or clonal large B-cells in peripheral blood or bone marrow.

          -  ECOG 0-2

          -  Adequate organ function

          -  Adequate bone marrow function

        Lenalidomide-related inclusion criteria:

          -  Able to take aspirin (81mg or 325mg) daily, warfarin, low molecular weight heparin, or
             equivalent anticoagulation as prophylactic medication.

          -  All study participants must be registered into the mandatory REVLIMID REMS® program,
             and be willing and able to comply with the requirements of REMS®.

          -  Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy
             test within 10 - 14 days prior to and again within 24 hours prior to starting
             REVLIMID® and must either commit to continued abstinence from heterosexual intercourse
             or begin TWO acceptable methods of birth control, one highly effective method and one
             additional effective method AT THE SAME TIME, at least 28 days before she starts
             taking REVLIMID®. FCBP must also agree to ongoing pregnancy testing.

          -  Males must agree to use a latex condom during sexual contact with a FCBP even if they
             have had a successful vasectomy.

        Exclusion Criteria:

          -  History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

          -  Known hypersensitivity to any of the study drugs

          -  Patients with a malignancy that has been treated, but not with curative intent, will
             be excluded, unless the malignancy has been in remission without treatment for 2 years
             prior to enrollment.

          -  Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding
             fungal infections of nail beds) or any major episode of infection requiring treatment
             with IV antibiotics or hospitalization (related to the completion of the course of
             antibiotics) within 4 weeks before the start of treatment

          -  Major surgery within 4 weeks prior to the start of treatment

          -  Known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus
             1 (HTLV-1) seropositive status

          -  Positive hepatitis serology

          -  Women who are pregnant or lactating

          -  Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment

          -  Uncontrolled diabetes mellitus

          -  Myocardial infarction within 6 months of starting study drug

          -  Other clinically significant heart disease
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas Kipps, M.D., Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03113695

Organization ID

161265


Responsible Party

Principal Investigator

Study Sponsor

University of California, San Diego


Study Sponsor

Thomas Kipps, M.D., Ph.D., Principal Investigator, University of California


Verification Date

April 2021