Observation for Chronic Lymphocytic Leukemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Lymphocytic Leukemia+1 MoreObservation - Other
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new anti-cancer drug (venetoclax) to see if it can help treat patients with chronic lymphocytic leukemia who have not received previous treatment. The drug is being added to the usual treatment of ibrutinib and obinutuzumab. The trial will also investigate whether patients who receive all three treatments and have no detectable chronic lymphocytic leukemia after one year of treatment, can stop taking ibrutinib.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 10 years

Year 10
Overall survival (OS)
Year 10
Progression-free survival (PFS)
Up to 10 years
Bone marrow (BM) minimal residual disease (MRD)- complete response (CR) rate
Incidence of adverse events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I (ibrutinib, obinutuzumab)
1 of 2
Arm II (ibrutinib, obinutuzumab, venetoclax)
1 of 2

Active Control

Experimental Treatment

454 Total Participants · 2 Treatment Groups

Primary Treatment: Observation · No Placebo Group · Phase 3

Arm II (ibrutinib, obinutuzumab, venetoclax)Experimental Group · 4 Interventions: Venetoclax, Observation, Obinutuzumab, Ibrutinib · Intervention Types: Drug, Other, Biological, Drug
Arm I (ibrutinib, obinutuzumab)ActiveComparator Group · 2 Interventions: Obinutuzumab, Ibrutinib · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
FDA approved
Obinutuzumab
FDA approved
Ibrutinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 10 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,071 Previous Clinical Trials
41,128,401 Total Patients Enrolled
Jennifer A WoyachPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
547 Total Patients Enrolled

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must be intermediate or high-risk Rai stage CLL or SLL.
You have neoplastic cells on immunophenotype (performed locally) that express the B cell surface markers of CD19 and CD20, as well as the T cell antigen CD5.
You have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with < 5000 B-cells per uL of blood but with disease-associated lymphadenopathy.
This blood submission is mandatory prior to registration/randomization to perform fluorescence in situ hybridization (FISH) centrally that will be used for stratification
You have ≥ 5 x10^9 B lymphocytes (5000/uL) in the peripheral blood measured by flow cytometry at any point in the course of the disease or less peripheral blood involvement but disease-associated lymphadenopathy.