Home/Loved One/NCT04269902
PHASE3RECRUITING
View on ClinicalTrials.gov

Comparing Biospecimen Collection with Bone Marrow Aspiration for chronic lymphocytic leukemia

Official title: Testing Early Treatment for Patients With High-Risk Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), EVOLVE CLL/SLL Study

Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study

Condition: Chronic Lymphocytic LeukemiaSponsor: National Cancer Institute (NCI)Target enrollment: 247

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Obinutuzumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Venetoclax

Given PO

Canadian Sites (8)

BCCA-Vancouver Cancer Centre

Vancouver, British Columbia, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

Atlantic Health Sciences Corporation-Saint John Regional Hospital

Saint John, New Brunswick, Canada

RECRUITING

QEII Health Sciences Centre/Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

ACTIVE_NOT_RECRUITING

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

ACTIVE_NOT_RECRUITING

Ottawa Hospital and Cancer Center-General Campus

Ottawa, Ontario, Canada

ACTIVE_NOT_RECRUITING

Jewish General Hospital

Montreal, Quebec, Canada

RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

ACTIVE_NOT_RECRUITING

Eligibility Criteria

See who this study is looking for50 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Participants must not require continued therapy with a strong inhibitor or inducer of CYP3A4/5, as venetoclax is extensively metabolized by CYP3A4/5
  • +Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • +Obinutuzumab has been associated with hepatitis reactivation. Participants must not have uncontrolled active infection with hepatitis B or C. Participants with latent hepatitis B infection must agree to take prophylaxis during and for 6 months following active protocolProtocolThe detailed plan a study must follow.Read more → therapy with V-O.
  • +Active infection with hepatitis B or C:
  • +Active infection is defined as detectable hepatitis B deoxyribonucleic acid (DNA) or hepatitis C ribonucleic acid (RNA) by quantitative polymerase chain reaction (PCR).
  • +Latent infection with hepatitis B:
  • +Hepatitis B surface antigen positive
  • +Anti-hepatitis B total core antibody positive
  • +Anti-hepatitis IgM core antibody undetectable
  • +Hepatitis B PCR undetectable
  • +Participants with latent hepatitis B infection must agree to take prophylaxis with anti-hepatitis agents during and for 6 months following active protocol therapy with V-O.
  • +Participants who have received intravenous immunoglobulin (IVIG) therapy within 6 months who are hepatitis B core total antibody positive but PCR undetectable are not mandated to take prophylaxis
  • +Participants must have a confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (collectively referred to as CLL throughout) according to the 2018 International Workshop on CLL. Participants must have been diagnosed within 18 months prior to registration
  • +Participants must have CLL-International Prognostic Index (CLL-IPI) score \>= 4 and/or complex cytogenetics (defined as 3+ chromosomal abnormalities)
  • +Cytogenetic AND/OR FISH analyses must be completed at a Clinical Laboratory Improvement Act (CLIA)-approved (or laboratories accredited under Accreditation Canada Diagnostics to conduct FISH analyses) laboratory within 18 months prior to registration. At minimum, FISH panel should use probes to detect for abnormalities in chromosomes 13q, 12, 11q, and 17p
  • +TP53 gene mutation analysis performed at any CLIA-approved (or laboratories accredited under Accreditation Canada Diagnostics) lab (if completed) must be obtained within 18 months prior to registration. This sequencing test is distinct from FISH studies for del(17p)
  • +Note: TP53 gene mutation analysis is recommended but not required if the participant meets disease-related study criteria via a combination of risk factors that totals a score of 4 on the CLL-IPI score and/or has complex cytogenetics completed
  • +Immunoglobulin heavy chain locus variable (IgVH) gene mutation analysis performed at any CLIA-approved lab (or laboratories accredited under Accreditation Canada Diagnostics) must be obtained prior to registration (at any time prior to registration)
  • +Serum beta-2 microglobulin level must be obtained within 28 days prior to registration
  • +Participants must not meet any of the IWCLL specified criteria for active CLL therapy
  • +Treatment with high dose corticosteroids and/or intravenous immunoglobulin for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
  • +Steroids used for treatment of conditions other than CLL/SLL must be at a dose of at most 20 mg/day of prednisone or equivalent corticosteroid at the time of registration
  • +Prior therapy with anti CD20 monoclonal antibodies is not allowed
  • +Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
  • +Participants must be \>= 18 years of age
  • +Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
  • +Platelet count \>= 100,000/mm\^3 within 28 days prior to registration
  • +Absolute neutrophil count (ANC) \>= 1,000/mm\^3 within 28 days prior to registration
  • +Creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
  • +Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
  • +Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease), within 28 days prior to registration
  • +Participants must be able to take oral medications
  • +Participants must not have current, clinically significant gastrointestinal malabsorption, in the opinion of treating doctor
  • +Participants must not have cirrhosis
  • +Latent infection is defined as meeting all of the following criteria:
  • +Participants must not have known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
  • +Participants must not have a history of stroke or intracranial hemorrhage within 6 months prior to enrollment
  • +Participants must not have uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
  • +Participants must not have any currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification
  • +Participants must not have a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
  • +Participants must agree to have specimens submitted for translational medicine (MRD) as outlined
  • +Participants must be offered the opportunity to participate in specimen banking for future research as outlined.
  • +NOTE: With participant's consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, the siteTrial siteA hospital or clinic where a study is actually run.Read more → must follow through with specimen submission as outlined
  • +Participants who are able to complete patient reported outcome (PRO) forms in English, Spanish, French, German, Russian or Mandarin must be offered the opportunity to participate in the quality of life assessments. (Those participants who are unable to read and write in English, Spanish, French, German, Russian or Mandarin may be registered to S1925 without contributing to the quality of life portion of the study.)
  • +Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • +NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review boardResearch Ethics Board (REB)The independent committee that must approve a study before it can run.Read more → approval for this study has been entered in the system
  • +Participants must not have received or be currently receiving any prior CLL-directed therapy, including non-protocol-related therapy, anti-cancer immunotherapy, experimental therapy (with exception of agents approved for emergency access use for the prevention or treatment of coronavirus disease 2019 \[COVID-19\]), or radiotherapy
  • +Participants with history of malignancy are allowed providing the cancer has not required active treatment within 2 years prior to registration (hormonal therapy is permissible). The following exceptions are permissible: basal cell, squamous cell skin, or non-melanomatous skin cancer, in situ cervical cancer, superficial bladder cancer not treated with intravesical chemotherapy or Bacillus Calmette-Guerin (BCG) within 6 months, localized prostate cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy, or prostate cancer with Gleason score ≤ 6, or localized breast cancer treated with surgical resection and/or radiation only or requiring no more than chronic hormonal therapy
  • +Participants must not have had major surgery within 30 days prior registration or minor surgery within 7 days prior to registration. Examples of major surgery include neurosurgical procedures, joint replacements, and surgeries that occur inside the thoracic or abdomino-pelvic cavities. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration of a joint. If a participant has had a bone marrow biopsy for diagnosis or evaluation of CLL, this will not exclude the participant from registration to the study. If there is a question about whether a surgery is major or minor, this should be discussed with the Study Chair
  • +Participants must not be pregnant or nursing, as there are no safety data available for these drug regimens during pregnancy. Women/men of reproductive potential must have agreed to use an effective contraceptive method. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

What is being given or done in this study: Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, and 3 more.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

There are 2 groups in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 247 people.

The study is currently expected to finish around October 2028.

The main measurement is taken over: From the day of registration on study until death from any cause with observations censored on the day of last contact for participants not known to have died, assessed up to 10 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Overall survival (OS) — measured over From the day of registration on study until death from any cause with observations censored on the day of last contact for participants not known to have died, assessed up to 10 years.

Functional Assessment of Cancer Therapy (FACT)-Leukemia total score — measured over At 2 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT04269902 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Biospecimen CollectionProcedure

Undergo collection of blood samples

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Bone Marrow AspirationProcedure

Undergo bone marrow aspiration

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Bone Marrow BiopsyProcedure

Undergo bone marrow biopsy

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Computed TomographyProcedure

Undergo CT

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About ObinutuzumabBiological

Given IV

From the trial registry — its own words, unedited.

What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.

Read the full explanation → · in clinical review

About Questionnaire AdministrationOther

Ancillary studies

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About VenetoclaxDrug

Given PO

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From the day of registration on study until death from any cause with observations censored on the day of last contact for participants not known to have died, assessed up to 10 years.

The study as a whole is currently expected to finish around 2028-10-01.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 247 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 121 locations, including: Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Saint John, New Brunswick, Canada; Halifax, Nova Scotia, Canada; Oshawa, Ontario, Canada; Ottawa, Ontario, Canada, and 115 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

Other Sites (162)

Hickman Cancer Center

Adrian, Michigan, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Henry Ford Cancer Institute-Downriver

Brownstown, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Caro Cancer Center

Caro, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township

Clinton Township, Michigan, United States

Henry Ford Medical Center-Fairlane

Dearborn, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Henry Ford Health Saint John Hospital

Detroit, Michigan, United States

Henry Ford River District Hospital

East China Township, Michigan, United States

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Genesee Hematology Oncology PC

Flint, Michigan, United States

And 142 more sites worldwide.

Worth passing on?

Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.

Review the Care Package

This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.