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BCL-2 Inhibitor

Accelerated Venetoclax Escalation for Chronic Lymphocytic Leukemia (SAVE Trial)

Phase 1
Recruiting
Led By Inhye Ahn, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progressive lymphocytosis with an increase of more than 50% over a 2-month period or LDT of <6 months. Lymphocyte doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months
Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <11.0 g/L) and/or thrombocytopenia (platelets <100 x 109/L)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Awards & highlights

SAVE Trial Summary

This trial is investigating whether an accelerated dose ramp-up of venetoclax is safe for patients with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Who is the study for?
This trial is for adults with newly diagnosed or relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Participants must have symptoms like anemia, weight loss, fatigue, fevers without infection, night sweats, and adequate organ function. They should not have had a recent stem cell transplant or other cancers and must be willing to use contraception.Check my eligibility
What is being tested?
The study tests if patients can safely handle a faster dose increase of Venetoclax compared to the standard schedule. It's for those at different risks for tumor lysis syndrome. Some may also receive Rituximab or Obinutuzumab as part of their treatment regimen.See study design
What are the potential side effects?
Venetoclax might cause rapid breakdown of cancer cells leading to tumor lysis syndrome; it can also affect blood counts and immune system functions. Rituximab and Obinutuzumab could cause infusion reactions, infections due to low white blood cell counts, and potential heart issues.

SAVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My white blood cell count has rapidly increased recently.
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My blood tests show worsening anemia or low platelets.
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I have had significant weight loss, fatigue, fevers, or night sweats without infection.
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My white blood cell count is healthy or can be with treatment.
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I have not been treated or my treatment didn’t work, and I may get venetoclax alone or with another therapy.
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I agree to use effective birth control or abstain from sex during the study.
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My spleen is very large, growing, or causing symptoms.
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I am 18 years old or older.
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I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma and need treatment.
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My blood condition doesn't improve with standard treatments.
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I can take care of myself but might not be able to do heavy physical work.
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My liver is working well.
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My kidney function is within the required range.
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My kidney function is normal.
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My lymph nodes are very large, growing, or causing symptoms.

SAVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Highest risk TLS group that can safely tolerate the daily ramp up
Secondary outcome measures
Complete response (CR) rate
Objective response rate (ORR)
Overall survival (OS)
+2 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

SAVE Trial Design

1Treatment groups
Experimental Treatment
Group I: VenetoclaxExperimental Treatment3 Interventions
Participants will be separated into two cohorts: Cohort A: Patients at low risk for TLS. Cohort B: Patients with both median and high risk for TLS. Five (5) participants from cohort A will be initially enrolled, if these first 5 participants tolerate the accelerated ramp-up, cohorts A and B will enroll simultaneously. All participants will be hospitalized and receive venetoclax daily with accelerated dose increases over 5 days to reach full dose. After reaching full dose, participants will be discharged and continue daily venetoclax at home. Per doctor assessment, some participants may also receive rituximab or obinutuzumab as part of the treatment regimen with venetoclax. Rituximab: Given every 28 days starting on the second study cycle and continuing for up to 6 cycles as per standard of care. Obinutuzumab: Days 1, 2, 8, and 15 of cycle 1 and once every 28 days there after for up to 6 cycles as per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Obinutuzumab
2015
Completed Phase 3
~3250
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,693 Total Patients Enrolled
Inhye Ahn, MDPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
175 Total Patients Enrolled
Jennifer Crombie, CrombiePrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Venetoclax (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04843904 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Venetoclax
Chronic Lymphocytic Leukemia Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT04843904 — Phase 1
Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04843904 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Venetoclax a reliable treatment option for patients?

"Minimal safety and efficacy data is available for Venetoclax, so it was granted a score of 1."

Answered by AI

For what illnesses has Venetoclax been proven to be an effective remedy?

"Venetoclax is therapeutically efficacious at treating diffuse large b-cell lymphoma (dlbcl) and various other illnesses, like b-cell lymphomas, polyangium and pemphigus vulgaris."

Answered by AI

Are there still opportunities to join this investigation?

"Affirmative, according to clinicaltrials.gov the medical trial is still actively recruiting participants. This study was initially posted on April 14th 2021 with its most recent update appearing June 1st 2022. 40 individuals need be found from a single location to participate in this experiment."

Answered by AI

Could you provide a rough estimate of the number of participants in this trial?

"Affirmative. The data hosted on clinicaltrials.gov indicates that this medical trial began accepting applicants since April 14th 2021, and was recently updated June 1st 2022. It is currently recruiting 40 patients from a single location."

Answered by AI

Could you elaborate on the prior research conducted concerning Venetoclax?

"At present, 652 studies of Venetoclax are underway with 123 in the third phase. While many trials are based in Edmonton, Alberta, there is a total of 21995 medical sites worldwide conducting research on this drug."

Answered by AI
~11 spots leftby Jun 2025