All > New Mexico > Chronic Lymphocytic Leukemia

Venetoclax for Lymphoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
HSHS Sacred Heart Hospital, Eau Claire, WILymphoma+1 MoreVenetoclax - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing the outcomes of starting treatment with venetoclax and obinutuzumab early versus starting treatment after symptoms appear, in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma.

Eligible Conditions
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
HDMP + rituximab as a means of debulking prior to initiating venetoclax.
1
CUDC-907
1
Treatment (pirtobrutinib and venetoclax)

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Up to 10 years

At 2 years
Functional Assessment of Cancer Therapy (FACT)-Leukemia total score
Month 3
FACT-Leukemia total score
The individual components of the FACT-Leukemia
Year 10
Relapse free survival
Year 10
Overall survival
Year 10
Event free survival
Year 10
Progression free survival
Up to 10 years
Incidence of adverse events
Overall Response rate
Patient compliance
Time to second treatment
Up to 36 months
Patient-reported health-related quality of life (HRQoL)

Trial Safety

Safety Progress

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

Similar Trials

1
HDMP + rituximab as a means of debulking prior to initiating venetoclax.
1
CUDC-907
2
Treatment (pirtobrutinib and venetoclax)

Side Effects for

Venetoclax + Rituximab
61%Neutropenia
39%Diarrhoea
21%Upper respiratory tract infection
21%Nausea
18%Fatigue
18%Cough
14%Constipation
14%Anaemia
14%Pyrexia
12%Thrombocytopenia
11%Headache
11%Nasopharyngitis
11%Insomnia
10%Bronchitis
9%Sinusitis
8%Infusion related reaction
8%Back pain
8%Vomiting
8%Pneumonia
7%Rash
7%Pharyngitis
7%Abdominal pain
6%Oedema peripheral
6%Hypokalaemia
6%Dyspnoea
6%Dizziness
6%Lower respiratory tract infection
6%Urinary tract infection
6%Neutrophil count decreased
6%Hyperkalaemia
6%Productive cough
6%Hypertension
6%Arthralgia
5%Alanine aminotransferase increased
5%Pruritus
5%Conjunctivitis
5%Oropharyngeal pain
4%Chills
4%Febrile neutropenia
4%Oral herpes
4%Decreased appetite
2%Influenza
2%Tumour lysis syndrome
2%Muscle spasms
2%Autoimmune haemolytic anaemia
2%Lung infection
2%Squamous cell carcinoma
1%Pancytopenia
1%Myocardial infarction
1%Deafness
1%Hyperpyrexia
1%Peritoneal tuberculosis
1%Urinary tract infection pseudomonal
1%Colorectal cancer
1%Lacunar infarction
1%Erysipelas
1%Disseminated intravascular coagulation
1%Vertigo
1%Oesophageal obstruction
1%Meningitis
1%Moraxella infection
1%Pneumonia influenzal
1%Pneumonia streptococcal
1%Sepsis
1%Viral upper respiratory tract infection
1%Humerus fracture
1%Dehydration
1%Diabetes mellitus
1%Skin cancer
1%Status epilepticus
1%Nephrolithiasis
1%Cervical dysplasia
1%Deep vein thrombosis
1%Eye haemorrhage
1%Sudden cardiac death
1%Uterine haemorrhage
1%Angina pectoris
1%Cardiac failure
1%Ventricular tachycardia
1%Ascites
1%Dyspepsia
1%Gastrointestinal haemorrhage
1%Haemophilus infection
1%Respiratory tract infection
1%Tooth abscess
1%Myelodysplastic syndrome
1%Immune thrombocytopenic purpura
1%Small intestinal obstruction
1%Diverticulitis
1%Herpes zoster
1%Herpes simplex otitis externa
1%Rhinovirus infection
1%Adenocarcinoma gastric
1%Campylobacter gastroenteritis
1%Cystitis
1%Gastroenteritis rotavirus
1%Viral infection
1%Respiratory tract infection fungal
1%Colon cancer
1%Hyperphosphataemia
1%Malignant melanoma
1%Metastatic malignant melanoma
1%Pancreatic carcinoma
1%Prostatic adenoma
1%Acute kidney injury
1%Bronchiectasis
1%Lung disorder
1%Pulmonary embolism
1%Appendicitis
1%Crohn's disease
1%Bile duct obstruction
1%Respiratory tract infection viral
1%Acute respiratory failure
1%Fluid overload
1%Basal cell carcinoma
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02005471) in the Venetoclax + Rituximab ARM group. Side effects include: Neutropenia with 61%, Diarrhoea with 39%, Upper respiratory tract infection with 21%, Nausea with 21%, Fatigue with 18%.

Trial Design

2 Treatment Groups

Arm I (delayed V-O)
1 of 2
Arm II (early V-O)
1 of 2

Active Control

Experimental Treatment

247 Total Participants · 2 Treatment Groups

Primary Treatment: Venetoclax · No Placebo Group · Phase 3

Arm II (early V-O)Experimental Group · 7 Interventions: Computed Tomography, Bone Marrow Aspiration, Biospecimen Collection, Obinutuzumab, Venetoclax, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug, Other, Other
Arm I (delayed V-O)ActiveComparator Group · 7 Interventions: Computed Tomography, Bone Marrow Aspiration, Biospecimen Collection, Obinutuzumab, Venetoclax, Quality-of-Life Assessment, Questionnaire Administration · Intervention Types: Procedure, Procedure, Procedure, Biological, Drug, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~3410
Bone Marrow Aspiration
2011
Completed Phase 2
~1730
Biospecimen Collection
2004
Completed Phase 1
~670
Obinutuzumab
FDA approved
Venetoclax
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
13,162 Previous Clinical Trials
41,167,046 Total Patients Enrolled
1,348 Trials studying Lymphoma
381,290 Patients Enrolled for Lymphoma
Deborah M StephensPrincipal InvestigatorSouthwest Oncology Group
1 Previous Clinical Trials
60 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 22 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Regional Cancer Center at Indian Path Community Hospital100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

For what purpose do doctors usually prescribe Venetoclax?

"Venetoclax is an effective treatment option for small lymphocytic lymphoma, [chronic lymphocytic leukemia](https://www.withpower.com/clinical-trials/chronic-lymphocytic-leukemia) (cll), and lymphoid leukemia." - Anonymous Online Contributor

Unverified Answer

Are there other examples of Venetoclax's efficacy?

"In 2012, CHU de Dijon was the first to study venetoclax. Since then, there have been a total of 367 completed studies with 290 ongoing trials. The majority of these live studies are based in Seattle, Washington." - Anonymous Online Contributor

Unverified Answer

Where are these clinical trials taking place?

"In total, this clinical trial is being conducted in 103 locations, with the three main sites being Swedish Medical Center-First Hill in Seattle, Washington, Crossroads Cancer Center in Effingham, Ohio, and Columbus Oncology and Hematology Associates Inc in Columbus, Texas." - Anonymous Online Contributor

Unverified Answer

Are we still enrolling individuals in this test?

"Correct, the clinical trial is recruiting patients as of right now. The original posting was on December 14th, 2020, and the most recent update was on November 4th, 2022. They are looking for 247 patients total, which will be recruited from 100 different locations." - Anonymous Online Contributor

Unverified Answer

What is the latest on Venetoclax's FDA approval process?

"While Phase 3 trials have less data supporting efficacy than later stage trials, there is still some evidence, and multiple rounds of data support Venetoclax's safety, so it receives a score of 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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