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

NCT03113695 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 161265
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Richter's Syndrome; CLL

Keywords

Richter's Syndrome; CLL; Chronic Lumphocytic Leukemia; obinutuzumab; HDMP; lenalidomide; cancer; methylprednisolone

Outcome Measures

Primary Outcomes (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

  Measured Via Adverse Events

  2 years

Secondary Outcomes (4)

• Overall response rate of RS and CLL

  12 months and 24 months

• Progression-free survival rate

  12 months and 24 months

• Overall survival rate

  12 months and 24 months

• Patients able to receive a subsequent stem cell transplant (percentage)

  12 months and 24 months

Study Arms (1)

obinutuzumab, lenalidomide, and HDMP

EXPERIMENTAL

Drug: Obinutuzumab; Drug: lenalidomide; Drug: HDMP

Interventions

Obinutuzumab DRUG

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)

obinutuzumab, lenalidomide, and HDMP

lenalidomide DRUG

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.

obinutuzumab, lenalidomide, and HDMP

HDMP DRUG

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

obinutuzumab, lenalidomide, and HDMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

obinutuzumab; Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Thomas J. Kipps, M.D., Ph.D.

  University of California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: December 20, 2017
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)