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Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

ConditionsChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The names of the study drugs involved in this study are:

* obinutuzumab * venetoclax * acalabrutinib

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of CLL or SLL according to WHO criteria

Participants must require therapy according to iwCLL 2018 guidelines

Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL

Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point

Disqualifiers

Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible.

Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients

Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator

Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)

Trial design

Design model

Single group

Treatments tested in this trial

  • Venetoclax

    Drug

    Tablet, taken by mouth

  • Obinutuzumab

    Drug

    Intravenous infusion

  • Acalabrutinib

    Drug

    Capsule, taken by mouth

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Venetoclax-Obinutuzumab +/- AcalabrutinibExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants alive at 1 year

Percent of participants with high and intermediate risk relapsed/refractory CLL who are alive at 1 year. The percent of patients who are alive at one-year (rOS) will be measured by monitoring you in clinic. An rOS of at least 90% will be considered promising whereas the rOS of 75% or less will be considered non-promising.

Time frame
1 year

Secondary outcomes

1

Overall Response Rate

The response will be classified per the 2018 iwCLL guidelines. The overall frequency of overall response will be tabulated and summarized descriptively

Time frame
1 year
2

Complete response rate

The response will be classified per the 2018 iwCLL guidelines. The overall frequency of complete response will be tabulated and summarized descriptively

Time frame
1 year
3

Frequency of undetectable minimum residual disease (uMRD) after 12 Months

Frequency of undetectable MRD response will be tabulated and summarized descriptively. The frequency of detectable MRD including the frequency of MRD "low positive" and MRD "high positive" will also be tabulated and summarized descriptively

Time frame
1 year
4

Undetectable MRD rate with addition of acalabrutinib to venetoclax-obinutuzumab among patients who fail to eradicate MRD with venetoclax-obinutuzumab

Among participants who fail to eradicate MRD with venetoclax-obinutuzumab (includes participants with detectable MRD at 12 months as well as those with progression prior to completion of 12 months of venetoclax-obinutuzumab), the frequency of uMRD following addition of acalabrutinib to VO will be tabulated and summarized descriptively.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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