Venetoclax monotherapy for Small Lymphocytic Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Small Lymphocytic Lymphoma+1 MoreVenetoclax monotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether people with CLL/SLL who have responded to treatment with venetoclax can stop treatment and remain off-treatment for a year or more.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
Proportion of patients able to remain off CLL/SLL directed therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Venetoclax with anti-CD20 monoclonal antibody
1 of 2
Venetoclax monotherapy
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Venetoclax monotherapy · No Placebo Group · Phase 2

Venetoclax with anti-CD20 monoclonal antibody
Drug
Experimental Group · 1 Intervention: Venetoclax with anti CD20 monoclonal antibody · Intervention Types: Drug
Venetoclax monotherapy
Drug
Experimental Group · 1 Intervention: Venetoclax monotherapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Adaptive BiotechnologiesIndustry Sponsor
9 Previous Clinical Trials
3,072 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,395 Total Patients Enrolled
2 Trials studying Small Lymphocytic Lymphoma
55 Patients Enrolled for Small Lymphocytic Lymphoma
Anthony Mato, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
211 Total Patients Enrolled
3 Trials studying Small Lymphocytic Lymphoma
60 Patients Enrolled for Small Lymphocytic Lymphoma
Lindsey Roeker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by the enrolling institution.
Peripheral blood, marrow, or lymph node involvement for fresh sample collection.
You have received venetoclax-based therapy for at least 6 months.
You are receiving venetoclax in combination with anti-CD20 monoclonal antibody
Patients must have two MRD-negative assessments (defined by ≥ 10^-5 sensitivity) on the peripheral blood by the clonoSEQ® assay at least 28 days apart