Early or Delayed Fludarabine and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT ID: NCT00513747

Last Updated: 2020-04-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving fludarabine together with rituximab may kill more cancer cells. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving fludarabine together with rituximab early is more effective than giving fludarabine and rituximab after observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine and rituximab to compare how well they work when given early or after observation in treating patients with previously untreated chronic lymphocytic leukemia.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OBJECTIVES:

Primary

* To determine if early treatment with chemoimmunotherapy comprising fludarabine phosphate and rituximab extends the time to second treatment in patients with genetically high-risk (unmutated IgV\_H), asymptomatic, previously untreated chronic lymphocytic leukemia (CLL).
* To determine the time to disease progression that would warrant second treatment.
* To determine overall survival.

Secondary

* To measure the proportion of patients with asymptomatic, previously untreated CLL who have mutated and unmutated IgV\_H genes.
* To determine the differences in acute and chronic toxicity of administering chemoimmunotherapy early to patients with genetically high-risk CLL compared to waiting until symptoms develop.
* To determine the effect of select pretreatment clinical and biological characteristics (such as interphase cytogenetic abnormalities, ZAP-70 expression, and p53 dysfunction \[primary and secondary\]) on response, time to second treatment, and overall survival of patients with genetically high-risk CLL randomized to early treatment.
* To determine the effect of select pretreatment clinical and biological characteristics (such as interphase cytogenetic abnormalities, ZAP-70 expression, and p53 dysfunction) on response, time to first and second treatments, and overall survival of patients with genetically high-risk CLL randomized to standard treatment (observation until symptoms occur).
* To describe the natural history of patients with genetically low-risk (mutated IgV\_H genes), asymptomatic, previously untreated CLL, in terms of time to initial treatment, response, progression, and survival.
* To determine the effect of select pretreatment characteristics on time to first treatment, response, progression, and survival of patients with genetically low-risk CLL.
* To correlate patterns of resistance that emerge in patients with unmutated IgV\_H genes who have relapsing or refractory CLL following receipt of chemoimmunotherapy with clonal evolution, including acquisition of high-risk karyotype abnormalities, p53 mutations, p53 dysfunction (primary and secondary), altered mRNA and protein expression related to treatment resistance, DNA mutations, microRNA gene expression, and methylation changes.
* To determine whether highly sensitive flow cytometry negativity at completion of therapy in patients randomized to early treatment is an effective surrogate marker for prolonged time to second treatment, overall survival, and other clinical benefits.
* To collect demographic data on familial CLL in newly diagnosed patients participating on this study.

OUTLINE: This is a multicenter study.

* Genetically high-risk disease: Patients are stratified according to age (\< 50 years vs 50 to 70 years vs \> 70 years) and presence of the high-risk genetic feature \[del(11)(q22.3) or del(17)(p13.1)\] by FISH (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive rituximab IV over 4 hours on days 1, 3, and 5 of week 1 and then on day 1 of weeks 5, 9, 13, 17, and 21. Patients also receive fludarabine phosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.
* Arm II: Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in arm I. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.
* Genetically low-risk disease: Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in arm I. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.

Patients undergo blood sample collection periodically for correlative studies.

After finishing treatment, patients are followed periodically.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I

Patients receive rituximab IV over 4 hours on days 1, 3, and 5 of week 1 and then on day 1 of weeks 5, 9, 13, 17, and 21. Patients also receive fludarabine phosphate IV over 30 minutes on days 1-5 of weeks 1, 5, 9, 13, 17, and 21. After completion of chemoimmunotherapy, patients are followed every 3 months until disease progression. At the time of disease progression, patients receive retreatment with chemoimmunotherapy as above or another treatment regimen.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

Given IV over 4 hours

fludarabine phosphate

Intervention Type DRUG

Given IV over 30 minutes

Arm II

Patients are followed every 3 months until disease progression. At the time of disease progression, patients receive rituximab and fludarabine phosphate as in arm I. Patients are then followed every 3 months until second disease progression. Patients with a second disease progression receive retreatment with chemoimmunotherapy as above or another treatment regimen.

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

Given IV over 4 hours

fludarabine phosphate

Intervention Type DRUG

Given IV over 30 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rituximab

Given IV over 4 hours

Intervention Type BIOLOGICAL

fludarabine phosphate

Given IV over 30 minutes

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Eligibility Criteria for Pre-Registration:

1. Patients must be within 6 months of the initial flow cytometric confirmation of B-cell chronic lymphocytic leukemia (CLL). This interval begins with the initial flow cytometric confirmation of disease.
2. Clinical and immunophenotypic evidence of CLL including:

2.1 An absolute lymphocytosis of \> 5,000/μL
* Morphologically, the lymphocytes must appear mature with \< 55% prolymphocytes.
* Local institution lymphocyte phenotype must reveal a predominant B-cell monoclonal population sharing a B-cell marker (CD19, CD20, CD23) with the CD5 antigen, in the absence of other pan-T-cell markers.
* Additionally, the B-cells must be monoclonal with regard to expression of either κ or λ and have surface immunoglobulin expression of low density.
* Patients with bright surface immunoglobulin levels must have CD23 coexpression and absence of t(11;14) on interphase cytogenetics or have negative tumor protein staining for cyclin D1.

2.2 Staging - Patients must be in the low category (i.e., only stages 0 or I) of the modified three-stage Rai staging system as described in the protocol.
3. Patients should not have evidence of active disease as demonstrated by any of the following criteria:

* Splenomegaly and/or massive/progressive lymphadenopathy that would require therapy
* Presence of weight loss \> 10% over the preceding 6 month period
* Grade 2 or 3 fatigue
* Fevers \> 100.5°F or night sweats for greater than 2 weeks without evidence of infection
* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months.
4. Prior Treatment: No prior therapy for CLL including corticosteroids for autoimmune complications that have developed since the initial diagnosis of CLL.
5. Age ≥ 18 years
6. Performance Status 0 - 1.
7. No HIV disease. Due to alterations in host immunity, patients known to have HIV infection may not be enrolled.
8. Non-pregnant and non-nursing. Due to the unknown teratogenic potential of chemotherapy, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.
9. Required Initial Laboratory Values:

* Creatinine ≤ 1.5 x upper limit of normal

Eligibility Criteria for Registration (to Low-Risk Cohort or High-Risk Cohort Randomization between Early Intervention Versus Observation with Later Treatment)

1. Successful determination of IgVH mutational status by reference laboratory.
2. Absence of progression of CLL, i.e., absence of the following:

* Progressive splenomegaly and/or lymphadenopathy on two independent measures spaced two weeks apart. If one assessment notes progression, this should be repeated prior to re-registration.
* Development of anemia (hemoglobin \< 11 g/dL) or thrombocytopenia (platelets \< 100,000/μL).
* Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of less than 6 months.
* Symptoms referable to CLL, including weight loss \> 10% over the preceding 6 month period; grade 2 or 3 fatigue; or fevers \> 100.5°F and/or night sweats for greater than 2 weeks without evidence of infection.
3. Required Laboratory Value:

* Creatinine ≤ 1.5 x upper limit of normal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John C. Byrd, MD

Role: STUDY_CHAIR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regional Medical Center

Anniston, Alabama, United States

Site Status

Clearview Cancer Institute

Huntsville, Alabama, United States

Site Status

Sparks Regional Medical Center

Fort Smith, Arkansas, United States

Site Status

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

Site Status

Virginia K. Crosson Cancer Center at St. Jude Medical Center

Fullerton, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Camino Medical Group - Treatment Center

Mountain View, California, United States

Site Status

Palo Alto Medical Foundation

Palo Alto, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Manchester Memorial Hospital

Manchester, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Site Status

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

Site Status

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

Site Status

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Site Status

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, United States

Site Status

Phoebe Cancer Center at Phoebe Putney Memorial Hospital

Albany, Georgia, United States

Site Status

John B. Amos Cancer Center

Columbus, Georgia, United States

Site Status

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois - Berwyn

Berwyn, Illinois, United States

Site Status

Illinois CancerCare - Bloomington

Bloomington, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Illinois CancerCare - Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare - Carthage

Carthage, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Site Status

Hematology and Oncology Associates

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Illinois CancerCare - Eureka

Eureka, Illinois, United States

Site Status

Galesburg Clinic, PC

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Galesburg

Galesburg, Illinois, United States

Site Status

Illinois CancerCare - Havana

Havana, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Kellogg Cancer Care Center

Highland Park, Illinois, United States

Site Status

Midwest Center for Hematology/Oncology

Joliet, Illinois, United States

Site Status

Illinois CancerCare - Kewanee Clinic

Kewanee, Illinois, United States

Site Status

North Shore Oncology and Hematology Associates, Limited - Libertyville

Libertyville, Illinois, United States

Site Status

Illinois CancerCare - Macomb

Macomb, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

Illinois CancerCare - Monmouth

Monmouth, Illinois, United States

Site Status

OSF Holy Family Medical Center

Monmouth, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Edward Hospital Cancer Center

Naperville, Illinois, United States

Site Status

La Grange Oncology Associates - Geneva

Naperville, Illinois, United States

Site Status

Cancer Care and Hematology Specialists of Chicagoland - Niles

Niles, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Illinois CancerCare - Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Illinois CancerCare - Pekin

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare - Peru

Peru, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Illinois CancerCare - Princeton

Princeton, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

Swedish-American Regional Cancer Center

Rockford, Illinois, United States

Site Status

Hematology Oncology Associates - Skokie

Skokie, Illinois, United States

Site Status

Illinois CancerCare - Spring Valley

Spring Valley, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Central Dupage Cancer Center

Winfield, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Community Hospital

Munster, Indiana, United States

Site Status

Reid Hospital & Health Care Services

Richmond, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Hematology Oncology Associates of the Quad Cities

Bettendorf, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status

Medical Oncology and Hematology Associates - West Des Moines

Clive, Iowa, United States

Site Status

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, United States

Site Status

Genesis Medical Center - West Campus

Davenport, Iowa, United States

Site Status

Mercy Capitol Hospital

Des Moines, Iowa, United States

Site Status

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Des Moines, Iowa, United States

Site Status

Medical Oncology and Hematology Associates at Mercy Cancer Center

Des Moines, Iowa, United States

Site Status

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

John Stoddard Cancer Center at Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Veterans Affairs Medical Center - Iowa City

Iowa City, Iowa, United States

Site Status

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Site Status

Mercy Medical Center - Sioux City

Sioux City, Iowa, United States

Site Status

St. Luke's Regional Medical Center

Sioux City, Iowa, United States

Site Status

Cedar Valley Medical Specialists, PC - West Ridgeway Avenue

Waterloo, Iowa, United States

Site Status

Covenant Cancer Treatment Center

Waterloo, Iowa, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Shawnee Mission Medical Center

Shawnee Mission, Kansas, United States

Site Status

Cotton-O'Neil Cancer Center

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Site Status

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

Site Status

CCOP - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Site Status

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

MaineGeneral Medical Center - Waterville

Waterville, Maine, United States

Site Status

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Site Status

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, United States

Site Status

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Site Status

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, United States

Site Status

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Green Bay Oncology, Limited - Escanaba

Escanaba, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

Site Status

Dickinson County Healthcare System

Iron Mountain, Michigan, United States

Site Status

Foote Memorial Hospital

Jackson, Michigan, United States

Site Status

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

Haematology-Oncology Associates of Ohio and Michigan, PC

Lambertville, Michigan, United States

Site Status

Sparrow Regional Cancer Center

Lansing, Michigan, United States

Site Status

St. Mary Mercy Hospital

Livonia, Michigan, United States

Site Status

Community Cancer Center of Monroe

Monroe, Michigan, United States

Site Status

Mercy Memorial Hospital - Monroe

Monroe, Michigan, United States

Site Status

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Site Status

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, United States

Site Status

Oncology Care Associates, PLLC

Saint Joseph, Michigan, United States

Site Status

Providence Cancer Institute at Providence Hospital - Southfield Campus

Southfield, Michigan, United States

Site Status

St. John Macomb Hospital

Warren, Michigan, United States

Site Status

Alexandria, Minnesota, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status

Mercy and Unity Cancer Center at Unity Hospital

Fridley, Minnesota, United States

Site Status

Hutchinson Area Health Care

Hutchinson, Minnesota, United States

Site Status

HealthEast Cancer Care at St. John's Hospital

Maplewood, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, United States

Site Status

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center - Minneapolis

Minneapolis, Minnesota, United States

Site Status

Veterans Affairs Medical Center - Minneapolis

Minneapolis, Minnesota, United States

Site Status

Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Site Status

Coborn Cancer Center

Saint Cloud, Minnesota, United States

Site Status

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, United States

Site Status

Park Nicollet Cancer Center

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

St. Francis Cancer Center at St. Francis Medical Center

Shakopee, Minnesota, United States

Site Status

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA - Woodbury

Woodbury, Minnesota, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States

Site Status

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

St. Joseph Medical Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Parvin Radiation Oncology

Kansas City, Missouri, United States

Site Status

CCOP - Kansas City

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Hospital

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, United States

Site Status

St. John's Regional Health Center

Springfield, Missouri, United States

Site Status

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, United States

Site Status

Midwest Hematology Oncology Group, Incorporated

St Louis, Missouri, United States

Site Status

Saint Louis University Cancer Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Site Status

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, United States

Site Status

David C. Pratt Cancer Center at St. John's Mercy

St Louis, Missouri, United States

Site Status

CCOP - Montana Cancer Consortium

Billings, Montana, United States

Site Status

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, United States

Site Status

Northern Rockies Radiation Oncology Center

Billings, Montana, United States

Site Status

St. Vincent Healthcare Cancer Care Services

Billings, Montana, United States

Site Status

Billings Clinic - Downtown

Billings, Montana, United States

Site Status

Bozeman Deaconess Cancer Center

Bozeman, Montana, United States

Site Status

St. James Healthcare Cancer Care

Butte, Montana, United States

Site Status

Big Sky Oncology

Great Falls, Montana, United States

Site Status

Great Falls Clinic - Main Facility

Great Falls, Montana, United States

Site Status

Sletten Cancer Institute at Benefis Healthcare

Great Falls, Montana, United States

Site Status

Great Falls, Montana, United States

Site Status

Northern Montana Hospital

Havre, Montana, United States

Site Status

St. Peter's Hospital

Helena, Montana, United States

Site Status

Glacier Oncology, PLLC

Kalispell, Montana, United States

Site Status

Kalispell Medical Oncology at KRMC

Kalispell, Montana, United States

Site Status

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status

Community Medical Center

Missoula, Montana, United States

Site Status

Guardian Oncology and Center for Wellness

Missoula, Montana, United States

Site Status

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, United States

Site Status

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, United States

Site Status

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, United States

Site Status

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

Site Status

Immanuel Medical Center

Omaha, Nebraska, United States

Site Status

Alegant Health Cancer Center at Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Veterans Affairs Medical Center - East Orange

East Orange, New Jersey, United States

Site Status

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, United States

Site Status

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

Fox Chase Virtua Health Cancer Program at Virtua West Jersey

Voorhees Township, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

Site Status

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

Adirondack Cancer Care - Glens Falls

Glens Falls, New York, United States

Site Status

Monter Cancer Center of the North Shore-LIJ Health System

Lake Success, New York, United States

Site Status

CCOP - North Shore University Hospital

Manhasset, New York, United States

Site Status

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Site Status

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Site Status

Stony Brook University Cancer Center

Stony Brook, New York, United States

Site Status

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Site Status

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, United States

Site Status

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Site Status

Batte Cancer Center at Northeast Medical Center

Concord, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Kinston Medical Specialists

Kinston, North Carolina, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Bismarck Cancer Center

Bismarck, North Dakota, United States

Site Status

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, United States

Site Status

Mid Dakota Clinic, PC

Bismarck, North Dakota, United States

Site Status

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, United States

Site Status

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States

Site Status

Mary Rutan Hospital

Bellefontaine, Ohio, United States

Site Status

Wood County Oncology Center

Bowling Green, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

North Coast Cancer Care - Clyde

Clyde, Ohio, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Site Status

CCOP - Columbus

Columbus, Ohio, United States

Site Status

Grant Medical Center Cancer Care

Columbus, Ohio, United States

Site Status

Mount Carmel Health - West Hospital

Columbus, Ohio, United States

Site Status

Doctors Hospital at Ohio Health

Columbus, Ohio, United States

Site Status

Grandview Hospital

Dayton, Ohio, United States

Site Status

Good Samaritan Hospital

Dayton, Ohio, United States

Site Status

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, United States

Site Status

Samaritan North Cancer Care Center

Dayton, Ohio, United States

Site Status

CCOP - Dayton

Dayton, Ohio, United States

Site Status

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status

Hematology Oncology Center

Elyria, Ohio, United States

Site Status

Blanchard Valley Medical Associates

Findlay, Ohio, United States

Site Status

Middletown Regional Hospital

Franklin, Ohio, United States

Site Status

Wayne Hospital

Greenville, Ohio, United States

Site Status

Charles F. Kettering Memorial Hospital

Kettering, Ohio, United States

Site Status

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status

St. Rita's Medical Center

Lima, Ohio, United States

Site Status

Lima Memorial Hospital

Lima, Ohio, United States

Site Status

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status

Northwest Ohio Oncology Center

Maumee, Ohio, United States

Site Status

St. Luke's Hospital

Maumee, Ohio, United States

Site Status

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, United States

Site Status

St. Charles Mercy Hospital

Oregon, Ohio, United States

Site Status

Toledo Clinic - Oregon

Oregon, Ohio, United States

Site Status

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Site Status

Mercy Medical Center

Springfield, Ohio, United States

Site Status

Community Hospital of Springfield and Clark County

Springfield, Ohio, United States

Site Status

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Site Status

Mercy Hospital of Tiffin

Tiffin, Ohio, United States

Site Status

Toledo Hospital

Toledo, Ohio, United States

Site Status

St. Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status

Medical University of Ohio Cancer Center

Toledo, Ohio, United States

Site Status

CCOP - Toledo Community Hospital

Toledo, Ohio, United States

Site Status

St. Anne Mercy Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, United States

Site Status

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, United States

Site Status

Fulton County Health Center

Wauseon, Ohio, United States

Site Status

Mount Carmel St. Ann's Cancer Center

Westerville, Ohio, United States

Site Status

Clinton Memorial Hospital

Wilmington, Ohio, United States

Site Status

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, United States

Site Status

Genesis - Good Samaritan Hospital

Zanesville, Ohio, United States

Site Status

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Site Status

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Site Status

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Site Status

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status

Kaiser Permanente Health Care - Portland

Portland, Oregon, United States

Site Status

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Site Status

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Site Status

Geisinger Hazleton Cancer Center

Hazleton, Pennsylvania, United States

Site Status

Riddle Memorial Hospital Cancer Center

Media, Pennsylvania, United States

Site Status

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Joan Karnell Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status

Cancer Center at Phoenixville Hospital

Phoenixville, Pennsylvania, United States

Site Status

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, United States

Site Status

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Site Status

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Site Status

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

McLeod Regional Medical Center

Florence, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

Mountainview Medical

Berlin Corners, Vermont, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

Fredericksburg Oncology, Incorporated

Fredericksburg, Virginia, United States

Site Status

St. Joseph Cancer Center

Bellingham, Washington, United States

Site Status

Olympic Hematology and Oncology

Bremerton, Washington, United States

Site Status

Columbia Basin Hematology

Kennewick, Washington, United States

Site Status

Harrison Poulsbo Hematology and Onocology

Poulsbo, Washington, United States

Site Status

Minor and James Medical, PLLC

Seattle, Washington, United States

Site Status

Group Health Central Hospital

Seattle, Washington, United States

Site Status

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Site Status

Polyclinic First Hill

Seattle, Washington, United States

Site Status

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Site Status

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Site Status

Evergreen Hematology and Oncology, PS

Spokane, Washington, United States

Site Status

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Site Status

Marshfield Clinic - Chippewa Center

Chippewa Falls, Wisconsin, United States

Site Status

Marshfield Clinic Cancer Care at Regional Cancer Center

Eau Claire, Wisconsin, United States

Site Status

Central Wisconsin Cancer Program at Agnesian HealthCare

Fond du Lac, Wisconsin, United States

Site Status

Oncology Alliance, SC - Milwaukee - East

Glendale, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

Site Status

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Site Status

Holy Family Memorial Medical Center Cancer Care Center

Manitowoc, Wisconsin, United States

Site Status

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Site Status

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States

Site Status

Saint Joseph's Hospital

Marshfield, Wisconsin, United States

Site Status

Marshfield Clinic - Lakeland Center

Minocqua, Wisconsin, United States

Site Status

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Ministry Medical Group at Saint Mary's Hospital

Rhinelander, Wisconsin, United States

Site Status

Marshfield Clinic - Indianhead Center

Rice Lake, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Sheboygan

Sheboygan, Wisconsin, United States

Site Status

Saint Michael's Hospital Cancer Center

Stevens Point, Wisconsin, United States

Site Status

Green Bay Oncology, Limited - Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin, United States

Site Status

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Site Status

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Moncton Hospital

Moncton, New Brunswick, Canada

Site Status

Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

Site Status

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, Canada

Site Status

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, Canada

Site Status

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

Deshields TL, Dueck AC, Rogers K, Brown JR, Shanafelt T, Mintzer D, Byrd JC. Perceived risk for cancer progression and psychological status in chronic lymphocytic leukemia patients: CALGB 70603 (Alliance). Leuk Lymphoma. 2019 Oct;60(10):2580-2583. doi: 10.1080/10428194.2019.1594218. Epub 2019 Mar 27.

Reference Type DERIVED
PMID: 30916608 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000537685

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-10501

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Aflibercept for Relapsed Multiple Myeloma
NCT00437034 TERMINATED PHASE2