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NCT04981912 · ClinicalTrials.gov registry record · Phase 1
Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients
A Phase 1 study of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, sponsored by University of California, San Diego.
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04981912: Active Phase 1 study of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, sponsored by University of California, San Diego.
NCT04981912 is a Phase 1 study of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma that is active but no longer recruiting, run by University of California, San Diego. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04981912, a Phase 1 study of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by University of California, San Diego.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to investigate whether the combination of rituximab and high dose methylprednisolone can be given together, can reduce the amount of cancer cells that are present prior to starting venetoclax, and therefore make it safer to take venetoclax. Patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) will be treated in this study. Subjects will be assessed for their risk of tumor lysis syndrome (TLS), a potentially serious side effect associated with venetoclax and rituxan. TLS is caused by the fast breakdown of cancer cells. TLS can lead to kidney failure or abnormal heart rhythm. Depending on their TLS risk, patients will be assigned to one of two treatment arms. Patients who are at high risk for TLS at baseline will receive HDMP/Rituximab for 1 cycle before beginning venetoclax. Patients who are at low risk for TLS at baseline will not receive HDMP/Rituximab and will instead start directly with venetoclax. Once the proper dose of venetoclax is reached, both arms will continue venetoclax for up to 2 years and receive rituximab for 5 cycles. The purpose is to determine if HDMP/Rituximab prior to venetoclax is efficient at reducing tumor burden and lowering the risk of developing TLS. Although all of these drugs are approved by the FDA for the treatment of patients with CLL or SLL, and although the combination of rituximab and venetoclax is approved by the FDA for the treatment of patients with CLL or SLL, the combination and dosing schedule in this trial are considered experimental.
Primary Outcome
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. Low Tumor Burden = All measurable lymph nodes with the largest diameter \< 5 cm by radiologic assessment AND ALC \< 25k/uL Medium Tumor Burden = Any measurable lymph node with the largest diameter \>/= 5 cm but \< 10 cm by radiographic assessment OR ALC \>/= 25k/uL Hi
Conditions Studied
Interventions
- DRUG HDMP + rituximab as a means of debulking prior to initiating venetoclax.
Study Locations (1)
California
- UCSD Moores Cancer Center - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2026-07-22 |
| Phase | Phase 1 |
What the registry record for NCT04981912 still lists
NCT04981912 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which HDMP + rituximab as a means of debulking prior to initiating venetoclax. is the first listed.
NCT04981912 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04981912 about?
NCT04981912 is a clinical study titled "Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients". The purpose of the study is to investigate whether the combination of rituximab and high dose methylprednisolone can be given together, can reduce the amount of cancer cells that are present prior to starting venetoclax, and therefore make it safer to take venetoclax. Patients with relapsed or refra...
What is the current status of trial NCT04981912?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-09-02. Estimated completion is 2026-07-22.
What conditions does trial NCT04981912 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04981912?
The interventions under investigation include: HDMP + rituximab as a means of debulking prior to initiating venetoclax. (DRUG).
Who is sponsoring clinical trial NCT04981912?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04981912 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04981912's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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