Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaPhase 1NCT04981912
Rituximab + High-Dose Methylprednisolone Debulking Prior to Venetoclax for CLL & SLL Patients
A Phase 1 study testing HDMP + rituximab as a means of debulking prior to initiating venetoclax. in people with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- What is being tested?
- HDMP + rituximab as a means of debulking prior to initiating venetoclax.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2021to 31 Jul 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet the following criteria for study entry:
- Subjects must be age 18 or older.
- Both men and women of all races and ethnic groups are eligible for this trial.
- Ability to understand and willingness to sign a written informed consent.
- Diagnosis: CLL or SLL, as documented in the medical record
- Disease Status/ Prior Therapy:
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- Must have had treatment for CLL/SLL with at least 1 line of prior therapy. (There is not requirement nor restriction for specific type of previous therapy, with the following exceptions: prior treatment with venetoclax within 6 months, prior progressive disease on venetoclax, or prior grade 3 or 4 toxicity (not including TLS) that directly lead to discontinuation of venetoclax; Prior HDMP/Rituximab is allowed unless there was no response (Stable Disease or Progressive Disease) or was within 3 months.)
- Indication for CLL or SLL therapy based on international working group (iwCLL) guidelines, which include: constitutional symptoms, bulky or symptomatic lymphadenopathy, bulky or symptomatic splenomegaly, rapid doubling of the ALC (approximately 6 months or less), or Rai stage 3 or 4 disease.
- Disease burden meets criteria for Medium or High Tumor Burden, based on Absolute lymphocyte count >/= 25k/uL or any lymph node 5 cm or greater in diameter. The ALC criteria must be met during the screening period. The imaging criteria may be based on radiologic study within 30 days of Cycle 0, Day 1.
- Has recovered from the toxic effects of prior therapy to their clinical baseline.
- Women of child-bearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree to not become pregnant for the duration of the study. Both men and women must agree to use a barrier method of contraception for the duration of the study and until 5 half-lives after the final dose of venetoclax (approximately 1 week), and at least 5 half-lives of final dose of Rituximab.
- ECOG performance status of 0-2
- Adequate hematologic function: Platelet count >/= 30k/uL, hemoglobin > 7 g/dL, AND ANC > 500/uL. (Values may be lower if due to marrow infiltration by CLL).
- Adequate renal function: creatinine clearance based on 24 hr collection >/= 40 ml/min; OR Calculated Creatinine clearance (CrCl) ≥ 40 mL/min (based upon the Cockcroft-Gault Equation [CrCl = (140-age) * actual wt (in kg) * (0.85 if female) / (72 * Cr)].
- Adequate hepatic function:
- Aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0X ULN
- Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
Who cannot join
- Patients who meet any of the following criteria will be excluded from study entry:
- Subject is known to be positive for HIV. (HIV testing is not required.)
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.
- Treatment with any of the following within 7 days prior to the first dose of venetoclax:
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- Steroid therapy for anti-neoplastic intent
- moderate or strong cytochrome P450 3A (CYP3A) inhibitors (see Appendix C for examples)
- moderate or strong CYP3A inducers (see Appendix C for examples)
- Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:
- grapefruit or grapefruit products
- Seville oranges (including marmalade containing Seville oranges)
- star fruit
- Prior CLL therapy:
- Biologic agent (monoclonal antibody) within 30 days for anti-neoplastic intent.
- Chemotherapy (purine analog or alkylating agent) or target small molecule agent within 14 days or 5 half-lives (whichever is shorter), or has not recovered to less than CTC grade 2 clinically significant adverse effect(s)/toxicity(s) of previous therapy.
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to any of the study drugs
- History of other malignancy that could affect compliance with the protocol or interpretation of results (example: patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will also 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 Cycle 0
- Major surgery (within 4 weeks prior to the start of Cycle 0), other than for diagnosis
- Women who are pregnant or lactating
- Uncontrolled diabetes mellitus (related to high dose steroid risk)
- Myocardial infarction within 6 months of starting study drug or other clinically significant heart disease (NYHA class 3 heart failure, uncontrolled hypertension)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: Rituximab and High-Dose Methylprednisolone Debulking Prior to Venetoclax for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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.
Read the detailed description
Objectives:
Primary:
- To determine the percentage of patients who have a reduction of lymphadenopathy (from greater than to less than 5 cm in largest diameter) and/or absolute lymphocyte count (from greater than to less than 25k/uL) following 1 or 2 cycles of HDMP + rituximab.
Secondary:
- To determine the rate of laboratory or clinical TLS with this strategy.
- To determine the safety (CTCAE4) of this approach.
- To determine the overall efficacy (iwCLL) of this overall strategy.
- To determine the percentage of patients who have undetectable minimal residual disease in the bone marrow.
Endpoints:
Primary:
- 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:
- 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.
- 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 2 cycles of HDMP + Rituximab.
- Rate of laboratory TLS (from start of treatment until completion of venetoclax ramp-up)
- Rate of clinical TLS (from start of treatment until completion of venetoclax ramp-up)
- 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.
- Undetectable minimal residual disease (MRD) rate based on bone marrow biopsy after 9 months of venetoclax, and at completion of treatment.
Single center, open-label, pilot/feasibility study to determine the feasibility of HDMP/R as a debulking approach prior to venetoclax.
Patients with CLL/SLL who require therapy, and have disease burden meeting criteria for Medium or High Risk Tumor Burden (based on: lymph nodes >/= 5 cm in diameter and/or absolute lymphocyte count >/= 25k/uL) are enrolled.
- Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden,
- If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes < 5cm in diameter AND absolute lymphocyte count < 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert.
- Patients who still have a disease burden (lymphadenopathy > 5 cm or ALC > 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up.
Upon completion of ramp-up (venetoclax to 400 mg), all patients will continue Venetoclax 400 mg (or highest tolerated dose) for up to 2 years. Patients will also continue rituximab 500 mg/m2 q 28 days through Cycle 6.
Endpoint Assessment:
- Assessment of the disease burden after a maximum of 2 cycles of HDMP + Rituximab is the primary endpoint.
- Assessment of the disease burden after 1 cycle of HDMP + Rituximab.
- Assessment of the disease burden after 2 cycles of HDMP + Rituximab (for the subset of patients that do not meet criteria for low tumor burden after 1 cycle).
- Clinical and laboratory TLS events between start of treatment and the completion of venetoclax dose-ramp up (Cycle 2, Day 1)
- Presence or absence of detectable MRD in the marrow will be assessed after approximately 9 months of venetoclax and completion of treatment.
- Radiology assessment after approximately 9 months of venetoclax and completion of study (unless prior imaging studies are without measurable disease)
- Being tested
- HDMP + rituximab as a means of debulking prior to initiating venetoclax.
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDMP + rituximab as a means of debulking prior to initiating venetoclax.Drug
Also called Methylnaphthidate + Riabni/Rituxan/Ruxience/Truxima
- Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden,
- If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes < 5cm in diameter AND absolute lymphocyte count < 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert.
- Patients who still have a disease burden (lymphadenopathy > 5 cm or ALC > 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | HDMP + rituximab as a means of debulking prior to initiating venetoclax. Receives: Drug: HDMP + rituximab as a means of debulking prior to initiating venetoclax. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients That Have a Decrease in Tumor Burden From Medium or High to Low
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
High Tumor Burden = Any measurable lymph node with the largest diameter >/= 10 cm by radiologic assessment OR ALC >/= 25k/uL AND any measurable lymph node with the largest diameter >/= 5 cm
Measured: 28 or 56 days
Secondary outcomes (7)
Percentage of Patients That Have a Decrease in Tumor Burden From Medium to Low
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 cycle 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
Measured: 3 years
Percentage of Patients That Have a Decrease in Tumor Burden if 2 Cycles of HDMP + Rituximab
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 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
High Tumor Burden = Any measurable lymph node with the largest diameter >/= 10 cm by radiologic assessment OR ALC >/= 25k/uL AND any measurable lymph node with the largest diameter >/= 5 cm
Measured: 56 days
Rate of Laboratory TLS (Tumor Lysis Syndrome)
Rate of laboratory TLS (from start of treatment until completion of venetoclax ramp-up)
Measured: 2.15 years
Rate of Clinical TLS
Rate of clinical TLS (from start of treatment until completion of venetoclax ramp-up)
Measured: 2.15 years
Adverse Events by CTCAE4 Definitions
Number of patients with non-hematological treatment-related adverse events by CTCAE4 definitions of grade 3 or higher, regardless of attribution
Measured: 2.15 years
Response Rates
Overall Response rate, Partial Response rate, and Complete response rate per iwCLL criteria after 9 months of venetoclax and at completion of treatment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 9 months and at end of study up to 3 years
Undetectable Minimal Residual Disease (MRD) Rate
Undetectable minimal residual disease (MRD) rate based on bone marrow biopsy after 9 months of venetoclax, and at completion of treatment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start2 Sep 2021
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Choi, University of California, San Diego
- Investigators
- Michael Choi, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981912
- Sponsor's protocol ID
- 182029
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2021
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab and High-Dose Methylprednisolone Debulking Prior to Venetoclax for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT04981912
- Acronym / sponsor ID
- 182029
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Posted 15 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary:
- To determine the percentage of patients who have a reduction of lymphadenopathy (from greater than to less than 5 cm in largest diameter) and/or absolute lymphocyte count (from greater than to less than 25k/uL) following 1 or 2 cycles of HDMP + rituximab.
Secondary:
- To determine the rate of laboratory or clinical TLS with this strategy.
- To determine the safety (CTCAE4) of this approach.
- To determine the overall efficacy (iwCLL) of this overall strategy.
- To determine the percentage of patients who have undetectable minimal residual disease in the bone marrow.
Endpoints:
Primary:
- 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:
- 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.
- 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 2 cycles of HDMP + Rituximab.
- Rate of laboratory TLS (from start of treatment until completion of venetoclax ramp-up)
- Rate of clinical TLS (from start of treatment until completion of venetoclax ramp-up)
- 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.
- Undetectable minimal residual disease (MRD) rate based on bone marrow biopsy after 9 months of venetoclax, and at completion of treatment.
Single center, open-label, pilot/feasibility study to determine the feasibility of HDMP/R as a debulking approach prior to venetoclax.
Patients with CLL/SLL who require therapy, and have disease burden meeting criteria for Medium or High Risk Tumor Burden (based on: lymph nodes >/= 5 cm in diameter and/or absolute lymphocyte count >/= 25k/uL) are enrolled.
- Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden,
- If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes < 5cm in diameter AND absolute lymphocyte count < 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert.
- Patients who still have a disease burden (lymphadenopathy > 5 cm or ALC > 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up.
Upon completion of ramp-up (venetoclax to 400 mg), all patients will continue Venetoclax 400 mg (or highest tolerated dose) for up to 2 years. Patients will also continue rituximab 500 mg/m2 q 28 days through Cycle 6.
Endpoint Assessment:
- Assessment of the disease burden after a maximum of 2 cycles of HDMP + Rituximab is the primary endpoint.
- Assessment of the disease burden after 1 cycle of HDMP + Rituximab.
- Assessment of the disease burden after 2 cycles of HDMP + Rituximab (for the subset of patients that do not meet criteria for low tumor burden after 1 cycle).
- Clinical and laboratory TLS events between start of treatment and the completion of venetoclax dose-ramp up (Cycle 2, Day 1)
- Presence or absence of detectable MRD in the marrow will be assessed after approximately 9 months of venetoclax and completion of treatment.
- Radiology assessment after approximately 9 months of venetoclax and completion of study (unless prior imaging studies are without measurable disease)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HDMP + rituximab as a means of debulking prior to initiating venetoclax.HDMP + rituximab as a means of debulking prior to initiating venetoclax. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must be age 18 or older.
- Both men and women of all races and ethnic groups are eligible for this trial.
- Ability to understand and willingness to sign a written informed consent.
- Diagnosis: CLL or SLL, as documented in the medical record
- Disease Status/ Prior Therapy:
Key exclusion criteria (24 listed)
- Subject is known to be positive for HIV. (HIV testing is not required.)
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Treatment with any of the following within 7 days prior to the first dose of venetoclax:
- Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:
- Prior CLL therapy:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDMP + rituximab as a means of debulking prior to initiating venetoclax.Also: Methylnaphthidate + Riabni/Rituxan/Ruxience/Truxima* Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden, * If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes < 5cm in diameter AND absolute lymphocyte count < 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert. * Patients who still have a disease burden (lymphadenopathy > 5 cm or ALC > 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up. | Drug | Arm A |
Primary outcome
Percentage of Patients That Have a Decrease in Tumor Burden From Medium or High to Low
Time frame: 28 or 56 days
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 High Tumor Burden = Any measurable lymph node with the largest diameter >/= 10 cm by radiologic assessment OR ALC >/= 25k/uL AND any measurable lymph node with the largest diameter >/= 5 cm
7 secondary outcomes
Percentage of Patients That Have a Decrease in Tumor Burden From Medium to Low
Time frame: 3 years
Percentage of Patients That Have a Decrease in Tumor Burden if 2 Cycles of HDMP + Rituximab
Time frame: 56 days
Rate of Laboratory TLS (Tumor Lysis Syndrome)
Time frame: 2.15 years
Rate of Clinical TLS
Time frame: 2.15 years
Adverse Events by CTCAE4 Definitions
Time frame: 2.15 years
Response Rates
Time frame: 9 months and at end of study up to 3 years
Undetectable Minimal Residual Disease (MRD) Rate
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Choi principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HDMP + rituximab as a means of debulking prior to initiating venetoclax. in people with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients That Have a Decrease in Tumor Burden From Medium or High to Low (time frame: 28 or 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.