Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03113695|
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : April 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Richter's Syndrome CLL||Drug: Obinutuzumab Drug: lenalidomide Drug: HDMP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2022|
|Estimated Study Completion Date :||August 2022|
|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
- 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
- Overall response rate of RS and CLL [ Time Frame: 12 months and 24 months ]Measure via the Cheson Criteria for response in lymphoma.
- 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.
- 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.
- 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
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
|United States, California|
|University of California, San Diego|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Thomas Kipps, M.D., Ph.D.||University of California|