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Corticosteroid

Rituximab + HDMP Debulking Before Venetoclax for Chronic B-Cell Leukemia

Phase 1
Waitlist Available
Led By Choi Michael, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child-bearing potential must agree to not become pregnant for the duration of the study
Patients must be age 18 or older
Must not have
Known active bacterial, viral, fungal, mycobacterial, or other infection
Women who are pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if using rituximab and high dose methylprednisolone together can reduce cancer cells in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to make venetoclax safer by lowering the risk of a serious side effect. Patients will be divided into groups based on their risk and treated accordingly. Rituximab is effective in treating various lymphomas and leukemias.

Who is the study for?
Adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have had at least one prior treatment but not venetoclax in the last 6 months, can join. They must be generally healthy, understand the study, and agree to use contraception. Excluded are those with severe allergies to monoclonal antibodies, recent heart attacks, uncontrolled infections or other cancers that could interfere.
What is being tested?
The trial tests if rituximab combined with high-dose methylprednisolone (HDMP) can reduce cancer cells before starting venetoclax for CLL/SLL patients. Depending on their risk of tumor lysis syndrome (TLS), participants will either receive HDMP/rituximab first or start directly on venetoclax. The goal is to see if this reduces TLS risk when beginning venetoclax therapy.
What are the potential side effects?
Possible side effects include kidney problems or abnormal heart rhythms due to rapid cancer cell breakdown (TLS). Other risks may involve reactions related to infusion treatments and the individual drugs' typical side effects like immune system impacts and organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to become pregnant during the study.
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I am 18 years old or older.
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My cancer is classified as medium or high in terms of how much it has spread.
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I have been diagnosed with CLL or SLL.
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I agree to use barrier methods for birth control.
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I can take care of myself and perform daily activities.
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My condition requires treatment for CLL or SLL as per international guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an active infection.
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I am not pregnant or breastfeeding.
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I am HIV positive.
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My diabetes is not well-controlled.
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I haven't had a heart attack or significant heart disease in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients that have a decrease in tumor burden from levels of disease that meet "Medium/High-tumor burden" criteria to meet "Low tumor burden" criteria for disease burden following 1 or 2 cycles of HDMP + Rituximab.
Secondary study objectives
Adverse events by CTCAE4 definitions
Overall Response rate, Partial Response rate, and Complete response rate per iwCLL criteria after 9 months of venetoclax and at completion of treatment
Percentage of patients that have a decrease in tumor burden from levels of disease that meet "Medium/High-tumor burden" c criteria to meet "Low tumor burden" criteria for disease burden following 1 cycle of HDMP + Rituximab.
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment1 Intervention
HDMP + rituximab as a means of debulking prior to initiating venetoclax.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Rituximab, a monoclonal antibody, targets the CD20 antigen on B-cells, leading to their destruction through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). High Dose Methylprednisolone (HDMP) is a corticosteroid that reduces inflammation and modulates the immune response, helping to decrease tumor burden and alleviate symptoms. These mechanisms are vital for Lymphocytic Leukemia/Lymphoma patients as they directly target malignant B-cells and manage disease symptoms, improving overall outcomes and quality of life.
Rituximab in combination with high-dose methylprednisolone for the treatment of chronic lymphocytic leukemia.Inhibition of interleukin 10 by rituximab results in down-regulation of bcl-2 and sensitization of B-cell non-Hodgkin's lymphoma to apoptosis.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,177 Previous Clinical Trials
1,573,620 Total Patients Enrolled
Choi Michael, MDPrincipal InvestigatorUniversity of California, San Diego

Media Library

High-Dose Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04981912 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Arm A
Chronic Lymphocytic Leukemia Clinical Trial 2023: High-Dose Methylprednisolone Highlights & Side Effects. Trial Name: NCT04981912 — Phase 1
High-Dose Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04981912 — Phase 1
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