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A Phase III Intergroup CLL Study of Asymptomatic Patients With Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation With Later Treatment in the High Risk Genetic Subset With IGVH Unmutated Disease

Phase 3
18 Years
Open (Enrolling)

Thank you

Trial Information

A Phase III Intergroup CLL Study of Asymptomatic Patients With Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation With Later Treatment in the High Risk Genetic Subset With IGVH Unmutated Disease



- 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.


- 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

- 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

- 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 for up to 25 years.

Inclusion Criteria


- Clinical and immunophenotypic evidence of B-cell chronic lymphocytic leukemia (CLL)
diagnosed within the past 6 months AND meets the following criteria:

- 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

- 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

- Low-risk category (i.e., only stages 0 or I) of the modified three-stage Rai staging

- No evidence of active or progressive disease as demonstrated by any of the following:

- Massive or progressive splenomegaly and/or lymphadenopathy that requires therapy

- Progressive lymphocytosis with an increase of > 50% over a 2-month period or an
anticipated doubling time of less than 6 months

- Presence of weight loss > 10% over the preceding 6-month period

- Grade 2 or 3 fatigue

- Fevers > 100.5°F and/or night sweats for greater than 2 weeks without evidence
of infection

- Development of anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelets <

- Must have undergone IgV_H mutation testing and be classified according to the

- Genetically low-risk disease

- IgV_H mutated

- Less than 98% IgV_H homology

- Genetically high-risk disease

- IgV_H unmutated

- At least 98% IgV_H homology


- Performance status 0-1

- Creatinine ≤ 1.5 times upper limit of normal

- No HIV disease

- Not pregnant or nursing

- Fertile patients must use effective contraception


- No prior therapy for CLL, including corticosteroids for autoimmune complications that
have developed since the initial diagnosis of CLL

- No concurrent hormones or other chemotherapy except for steroids for hypersensitivity
reactions or new adrenal failure (chronic requirement for steroids is an exclusion
criterion for this study) or hormones for non-disease-related conditions (e.g.,
insulin for diabetes)

- No concurrent palliative radiotherapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

John C. Byrd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2008

Completion Date:

December 2033

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • stage 0 chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



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Saint Luke's Hospital - South Overland Park, Kansas  66213
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Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Truman Medical Center - Hospital Hill Kansas City, Missouri  64108
St. Joseph Medical Center Kansas City, Missouri  64114
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
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Liberty Hospital Liberty, Missouri  64068
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
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Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
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Monter Cancer Center of the North Shore-LIJ Health System Lake Success, New York  11042
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Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
St. Joseph Cancer Center Bellingham, Washington  98225
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Marshfield Clinic - Chippewa Center Chippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Oncology Alliance, SC - Milwaukee - East Glendale, Wisconsin  53212-1038
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - Sheboygan Sheboygan, Wisconsin  53081
Saint Michael's Hospital Cancer Center Stevens Point, Wisconsin  54481
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Mid Dakota Clinic, PC Bismarck, North Dakota  58501
Saint Louis University Cancer Center Saint Louis, Missouri  63110
Community Hospital Munster, Indiana  46321
Memorial Hospital of Rhode Island Pawtucket, Rhode Island  02860
Phoebe Cancer Center at Phoebe Putney Memorial Hospital Albany, Georgia  31702
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Regional Cancer Center at Oconomowoc Memorial Hospital Oconomowoc, Wisconsin  53066
Dana-Farber/Brigham and Women's Cancer Center Boston, Massachusetts  02115
Kinston Medical Specialists Kinston, North Carolina  28501
Manchester Memorial Hospital Manchester, Connecticut  06040-4188
New Mexico Cancer Care Associates Santa Fe, New Mexico  87505-7670
McLeod Regional Medical Center Florence, South Carolina  29501
Cedar Valley Medical Specialists, PC - West Ridgeway Avenue Waterloo, Iowa  50702
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Veterans Affairs Medical Center - Iowa City Iowa City, Iowa  52246-2208
Cancer Center at Phoenixville Hospital Phoenixville, Pennsylvania  19460
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Oncology Care Associates, PLLC Saint Joseph, Michigan  49085
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Memorial Medical Center Modesto, California  95355
Illinois CancerCare - Bloomington Bloomington%, Illinois  61701
Illinois CancerCare - Canton Canton, Illinois  61520
Illinois CancerCare - Carthage Carthage, Illinois  62321
Elmhurst Memorial Hospital Elmhurst, Illinois  60126
Illinois CancerCare - Eureka Eureka, Illinois  61530
Illinois CancerCare - Galesburg Galesburg, Illinois  61401
Illinois CancerCare - Havana Havana, Illinois  62644
Illinois CancerCare - Kewanee Clinic Kewanee, Illinois  61443
Illinois CancerCare - Macomb Macomb, Illinois  61455
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
OSF Holy Family Medical Center Monmouth, Illinois  61462
Illinois CancerCare - Monmouth Monmouth, Illinois  61462
Illinois CancerCare - Community Cancer Center Normal, Illinois  61761
Illinois CancerCare - Pekin Pekin, Illinois  61603
Illinois CancerCare - Peru Peru, Illinois  61354
Illinois CancerCare - Princeton Princeton, Illinois  61356
Illinois CancerCare - Spring Valley Spring Valley, Illinois  61362
Riddle Memorial Hospital Cancer Center Media, Pennsylvania  19063
Medcenter One Hospital Cancer Care Center Bismarck, North Dakota  58501
St. Alexius Medical Center Cancer Center Bismarck, North Dakota  58502
Regional Medical Center Anniston, Alabama  36202
Camino Medical Group - Treatment Center Mountain View, California  94040
Virginia K. Crosson Cancer Center at St. Jude Medical Center Fullerton, California  92835
Central Wisconsin Cancer Program at Agnesian HealthCare Fond du Lac, Wisconsin  54935
Clearview Cancer Institute Huntsville, Alabama  35805
Central Dupage Cancer Center Warrenville, Illinois  60555
MaineGeneral Medical Center - Waterville Waterville, Maine  04901
Sparks Regional Medical Center Fort Smith, Arkansas  72901