- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113695
Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome
July 1, 2022 updated by: Thomas Kipps, University of California, San Diego
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: obinutuzumab, lenalidomide, and HDMP
|
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)
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.
methylprednisolone 1000 mg/m2 (ie HDMP) on days 1-5 of cycles 1-4
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate of RS and CLL
Time Frame: 12 months and 24 months
|
Measure via the Cheson Criteria for response in lymphoma.
|
12 months and 24 months
|
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.
|
12 months and 24 months
|
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.
|
12 months and 24 months
|
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
|
12 months and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas J. Kipps, M.D., Ph.D., University of California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2017
Primary Completion (Actual)
May 2, 2022
Study Completion (Actual)
May 2, 2022
Study Registration Dates
First Submitted
April 10, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
July 1, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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