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Trial record 13 of 91 for:    CLL [CONDITION] Lenalidomide [TREATMENT]

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

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ClinicalTrials.gov Identifier: NCT03113695
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Kipps, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Richter's Syndrome CLL Drug: Obinutuzumab Drug: lenalidomide Drug: HDMP Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: obinutuzumab, lenalidomide, and HDMP Drug: Obinutuzumab
obinutuzumab 1000 mg x 8 doses (first dose split on Cycle 1 days 1 100mg and 2 900mg; then day 8 and 15 of cycle 1; then day 1 of cycles 2-6, each cycle being 28 days long)

Drug: lenalidomide
lenalidomide PO daily. The starting dose of lenalidomide is 5 mg PO daily. Starting on C2D1, the dose increases every 2 weeks in 5 mg increments to a maximum of 25 mg PO daily. Patients will continue lenalidomide until disease progression, unacceptable toxicity, or subsequent therapy.

Drug: HDMP
methylprednisolone 1000 mg/m2 (ie HDMP) on days 1-5 of cycles 1-4




Primary Outcome Measures :
  1. Safety and tolerability of the combination of obinutuzumab, lenalidomide, and high dose methylprednisolone in treatments with Richter's Syndrome (RS) measured Via Adverse Events [ Time Frame: 2 years ]
    Measured Via Adverse Events


Secondary Outcome Measures :
  1. Overall response rate of RS and CLL [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma.

  2. Progression-free survival rate [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma. PFS is defined as the time from entry onto a study until lymphoma progression or death as a result of any cause.

  3. Overall survival rate [ Time Frame: 12 months and 24 months ]
    Measure via the Cheson Criteria for response in lymphoma. Defined as the time from entry onto the clinical trial until death as a result of any cause.

  4. Patients able to receive a subsequent stem cell transplant (percentage) [ Time Frame: 12 months and 24 months ]
    Measure by percentage of patients able to receive subsequent tell cell transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113695


Contacts
Contact: Thomas Kipps 858-534-5400 tkipps@ucsd.edu
Contact: Michael Choi (858) 534-1765 mychoi@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Thomas Kipps, MD, PhD       tkipps@ucsd.edu   
Principal Investigator: Thomas Kipps, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Thomas Kipps, M.D., Ph.D. University of California

Responsible Party: Thomas Kipps, Deputy Director, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03113695     History of Changes
Other Study ID Numbers: 161265
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Thomas Kipps, University of California, San Diego:
Richter's Syndrome
CLL
Chronic Lumphocytic Leukemia
obinutuzumab
HDMP
lenalidomide
cancer
methylprednisolone

Additional relevant MeSH terms:
Lenalidomide
Syndrome
Disease
Pathologic Processes
Thalidomide
Obinutuzumab
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids