Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
161265
- NCT ID:
NCT03113695
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Obinutuzumab | | obinutuzumab, lenalidomide, and HDMP |
| lenalidomide | | obinutuzumab, lenalidomide, and HDMP |
| HDMP | | obinutuzumab, lenalidomide, and HDMP |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| obinutuzumab, lenalidomide, and HDMP | Experimental | | - Obinutuzumab
- lenalidomide
- HDMP
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | 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 |
| Safety Issue: | |
| Description: | Measured Via Adverse Events |
Secondary Outcome Measures
| Measure: | Overall response rate of RS and CLL |
| Time Frame: | 12 months and 24 months |
| Safety Issue: | |
| Description: | Measure via the Cheson Criteria for response in lymphoma. |
| Measure: | Progression-free survival rate |
| Time Frame: | 12 months and 24 months |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Overall survival rate |
| Time Frame: | 12 months and 24 months |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Patients able to receive a subsequent stem cell transplant (percentage) |
| Time Frame: | 12 months and 24 months |
| Safety Issue: | |
| Description: | Measure by percentage of patients able to receive subsequent tell cell transplant |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | University of California, San Diego |
Trial Keywords
- Richter's Syndrome
- CLL
- Chronic Lumphocytic Leukemia
- obinutuzumab
- HDMP
- lenalidomide
- cancer
- methylprednisolone
Last Updated
April 9, 2021
