Pentostatin, Cyclophosphamide, and Rituximab Followed By Campath-1H in Patients With Relapsed or Refractory B-Cell CLL
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Leukemia |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 120 |
Updated: | 3/1/2019 |
Start Date: | December 16, 2004 |
End Date: | May 6, 2018 |
Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as pentostatin, cyclophosphamide, and
lenalidomide work in different ways to stop cancer cells from dividing so they stop growing
or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them
or deliver cancer-killing substances to them without harming normal cells. Combining
chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab,
and lenalidomide work in treating patients with relapsed or refractory B-cell chronic
lymphocytic leukemia.
lenalidomide work in different ways to stop cancer cells from dividing so they stop growing
or die. Monoclonal antibodies, such as rituximab can locate cancer cells and either kill them
or deliver cancer-killing substances to them without harming normal cells. Combining
chemotherapy with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well pentostatin, cyclophosphamide, rituximab,
and lenalidomide work in treating patients with relapsed or refractory B-cell chronic
lymphocytic leukemia.
OBJECTIVES:
Primary
- Determine the objective response rate (complete remission, partial remission [PR], or
nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia
(CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by
lenalidomide.
- Determine the presence of minimal residual disease in patients treated with this
regimen.
Secondary
- Determine the toxicity of this regimen in these patients.
- Evaluate the toxicity of the combined therapy, PCR with lenalidomide, in patients with
previously treated B-CLL.
- Determine the overall and progression-free survival of patients treated with this
regimen.
- Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR,
SD, or PD and who subsequently convert to a higher response category after lenalidomide.
- Correlate V_H gene mutation status and CD38 expression of the CLL B-cell clones with
clinical outcome in patients treated with this regimen.
- Correlate the differential expression of genes in the leukemic cells with clinical
outcome in patients treated with this regimen.
- Correlate surface phenotype and genetic defects of the CLL B-cell clones with clinical
outcome and gene expression patterns in patients treated with this regimen.
Exploratory
- Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic
molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular
density by immunohistochemistry) at baseline, after PCR, after lenalidomide, every six
months (serum only), and at time of response assessment (marrow).
- Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study
entry and at the end of the therapy and assess the association between the VH gene
mutation status and CD38 expression and clinical outcome.
- Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel)
information on CLL-B cell clones and associate with clinical outcome.
- Monitor the T-cell status by repertoire and flow cytometry analysis to determine the
nature and extent of T-cell deficiency induced by the PCR and lenalidomide treatment and
assess any association with clinical outcome and toxicities.
OUTLINE: This is a multicenter study.
Pentostatin, cyclophosphamide, and rituximab (PCR)* therapy: Patients receive pentostatin IV
over 10-30 minutes, cyclophosphamide IV over 30-60 minutes, and rituximab** IV on day 1.
Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 or
pegfilgrastim SC on day 1 and continuing until blood counts recover. Treatment repeats every
28 days for a total of 6 courses in the absence of unacceptable toxicity.
NOTE: *Patients demonstrating progression while receiving PCR must have completed 2 courses
of PCR prior to proceeding to lenalidomide therapy.
NOTE: **Patients receive rituximab IV on days 1, 3, and 5 for course 1 only; for courses 2-6,
patients receive rituximab on day 1 only.
Lenalidomide*** therapy: Eight weeks after completion of PCR therapy or when diagnosed with
progressive disease, patients receive lenalidomide orally (PO) on days 1-28. In the absence
of disease progression or unacceptable toxicity, treatment repeats every 28 days for patients
with partial remission (PR), stable disease, or progressive disease after PCR. Patients who
achieve complete remission proceed to clinical observation.
NOTE: ***The alemtuzumab therapy was replaced by lenalidomide therapy in May, 2011.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-110 patients will be accrued for this study within 1.5
years.
Primary
- Determine the objective response rate (complete remission, partial remission [PR], or
nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia
(CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by
lenalidomide.
- Determine the presence of minimal residual disease in patients treated with this
regimen.
Secondary
- Determine the toxicity of this regimen in these patients.
- Evaluate the toxicity of the combined therapy, PCR with lenalidomide, in patients with
previously treated B-CLL.
- Determine the overall and progression-free survival of patients treated with this
regimen.
- Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR,
SD, or PD and who subsequently convert to a higher response category after lenalidomide.
- Correlate V_H gene mutation status and CD38 expression of the CLL B-cell clones with
clinical outcome in patients treated with this regimen.
- Correlate the differential expression of genes in the leukemic cells with clinical
outcome in patients treated with this regimen.
- Correlate surface phenotype and genetic defects of the CLL B-cell clones with clinical
outcome and gene expression patterns in patients treated with this regimen.
Exploratory
- Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic
molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular
density by immunohistochemistry) at baseline, after PCR, after lenalidomide, every six
months (serum only), and at time of response assessment (marrow).
- Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study
entry and at the end of the therapy and assess the association between the VH gene
mutation status and CD38 expression and clinical outcome.
- Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel)
information on CLL-B cell clones and associate with clinical outcome.
- Monitor the T-cell status by repertoire and flow cytometry analysis to determine the
nature and extent of T-cell deficiency induced by the PCR and lenalidomide treatment and
assess any association with clinical outcome and toxicities.
OUTLINE: This is a multicenter study.
Pentostatin, cyclophosphamide, and rituximab (PCR)* therapy: Patients receive pentostatin IV
over 10-30 minutes, cyclophosphamide IV over 30-60 minutes, and rituximab** IV on day 1.
Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 3 or
pegfilgrastim SC on day 1 and continuing until blood counts recover. Treatment repeats every
28 days for a total of 6 courses in the absence of unacceptable toxicity.
NOTE: *Patients demonstrating progression while receiving PCR must have completed 2 courses
of PCR prior to proceeding to lenalidomide therapy.
NOTE: **Patients receive rituximab IV on days 1, 3, and 5 for course 1 only; for courses 2-6,
patients receive rituximab on day 1 only.
Lenalidomide*** therapy: Eight weeks after completion of PCR therapy or when diagnosed with
progressive disease, patients receive lenalidomide orally (PO) on days 1-28. In the absence
of disease progression or unacceptable toxicity, treatment repeats every 28 days for patients
with partial remission (PR), stable disease, or progressive disease after PCR. Patients who
achieve complete remission proceed to clinical observation.
NOTE: ***The alemtuzumab therapy was replaced by lenalidomide therapy in May, 2011.
Patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-110 patients will be accrued for this study within 1.5
years.
Inclusion criteria:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria:
- Peripheral blood absolute lymphocyte count greater than 5,000/mm^3
- Lymphocytosis must comprise small to moderate size lymphocytes with no greater
than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically
- Phenotypically characterized CLL defined by the following:
- Predominant population of cells share B-cell antigens with CD5 in the
absence of other pan-T-cell markers (CD3 or CD2)
- B cell expresses either kappa or lambda light chains
- Surface immunoglobulin with low cell surface density expression
- Requires chemotherapy, as indicated by any of the following:
- Disease-related symptoms
- Weight loss of 10% or more within the past 6 months
- Extreme fatigue
- Fevers greater than 100.5°F for 2 weeks without evidence of infection
- Night sweats without evidence of infection
- Evidence of progressive marrow failure manifested by the development of or
worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia
(platelet count no greater than 100,000/mm^3)
- Massive (i.e., greater than 6 cm below left costal margin) or progressive
splenomegaly
- Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or
progressive adenopathy
- Progressive lymphocytosis with an increase of greater than 50% over a 2-month
period OR an anticipated doubling time of less than 6 months
- Demonstrated progression after at least 1 course of either an alkylating agent-based
or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a
meaningful response OR relapsed after prior therapy
- Patients who have relapsed after a pentostatin-based regimen are eligible
provided the response was greater than 12 months prior to study entry
- 18 and over
- ECOG 0-2
- Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert
syndrome)
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance ≥ 30 mL/min
- Negative pregnancy test
- Fertile patients must use 2 methods of effective contraception (including 1 barrier
method) for at least 28 days before starting lenalidomide, while participating in the
study, and for at least 28 days after discontinuation/stopping lenalidomide
- At least 8 weeks since prior rituximab
- At least 6 weeks since prior chemotherapy
- At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy
- PCR therapy at least 1 year prior to study entry allowed
Exclusion criteria:
- Bone marrow dysplasia related to prior therapy
- New York Heart Association class III or IV heart failure
- Prior lenalidomide
- Other malignancy within the past 2 years except squamous cell or basal cell skin
cancer or carcinoma in situ of the cervix
- Pregnant or nursing
- Concurrent oral or IV antibiotics for active infection
We found this trial at
143
sites
800 S Washington Ave
Saginaw, Michigan 48601
Saginaw, Michigan 48601
(989) 907-8115
Seton Cancer Institute at Saint Mary's - Saginaw At St. Mary's of Michigan, we continue...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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2500 Metrohealth Dr # C2100
Cleveland, Ohio 44109
Cleveland, Ohio 44109
(216) 778-5802
MetroHealth Cancer Care Center at MetroHealth Medical Center At the MetroHealth Cancer Care Center, we...
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100 North Academy Ave
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
Geisinger Cancer Institute at Geisinger Health Since 1915, Geisinger Medical Center has been known as...
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1719 East 19th Avenue
Denver, Colorado 80218
Denver, Colorado 80218
(303) 839-6000
Presbyterian - St. Luke's Medical Center Presbyterian/St. Luke's Medical Center and the Rocky Mountain Hospital...
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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1920 Libal Street
Green Bay, Wisconsin 54307
Green Bay, Wisconsin 54307
(920) 433-8889
St. Vincent Hospital Regional Cancer Center Our group of 19 oncologists, including the region's only...
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19229 Mack Ave
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
(866) 246-4673
Van Elslander Cancer Center at St. John Hospital and Medical Center We built the Van...
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500 University Drive
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Penn State Milton S....
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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902 Savannah Road
Lewes, Delaware 19958
Lewes, Delaware 19958
(302) 645-3770
Tunnell Cancer Center at Beebe Medical Center The Robert & Eolyne Tunnell Cancer Center at...
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42 E Laurel Rd # 2545
Voorhees, New Jersey 08043
Voorhees, New Jersey 08043
(800) 826-6737
Cancer Institute of New Jersey at Cooper - Voorhees Cooper University Health Care, the clinical...
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825 N Emporia Ave
Wichita, Kansas 67214
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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5301 East Huron River Drive
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
1.877.590.5995
CCOP - Michigan Cancer Research Consortium The Community Clinical Oncology Program (CCOP) is a comprehensive...
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Saint Joseph Mercy Cancer Center Saint Joseph Mercy Health System is one of Michigan's most...
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Aurora Presbyterian Hospital At The Medical Center of Aurora and Centennial Medical Plaza, we treat...
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MeritCare Bemidji Sanford Health is an integrated health system headquartered in the Dakotas and is...
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1055 N Curtis Rd
Boise, Idaho 83706
Boise, Idaho 83706
(208) 367-2121
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Saint Alphonsus Health System...
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Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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2222 N. Nevada Avenue
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
(719) 776-5000
Penrose Cancer Center at Penrose Hospital Through a full range of clinical trials, genetic counseling,...
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11850 Blackfoot St. NW
Suite 130
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
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18101 Oakwood Blvd
Dearborn, Michigan 48124
Dearborn, Michigan 48124
(313) 593-8620
Oakwood Cancer Center at Oakwood Hospital and Medical Center In today's health care environment, a...
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2300 N. Edward Street
Decatur, Illinois 62526
Decatur, Illinois 62526
217-876-8121
Decatur Memorial Hospital Cancer Care Institute An American flag bearing only 48 stars waved above...
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St. Anthony Central Hospital The St. Anthony Medical Campus in Lakewood combines our heritage of...
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Rose Medical Center Well known as a Denver institution and a 9th Avenue landmark for...
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Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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CCOP - MeritCare Hospital The Sanford Community Cancer Consortium is a "newly" formed CCOP, merging...
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Cancer Center of Kansas - Fort Scott Dr. H.E. Hynes founded Cancer Center of Kansas,...
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550 Osborne Road
Fridley, Minnesota 55432
Fridley, Minnesota 55432
763-236-5000
Mercy and Unity Cancer Center at Unity Hospital Patients and their families are the heart...
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North Colorado Medical Center NCMC is a fully accredited, private, non-profit facility licensed to operate...
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114 Woodland St, Hartford
Hartford, Connecticut 06105
Hartford, Connecticut 06105
(860) 714-4000
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center While better...
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Geisinger Hazleton Cancer Center At the Geisinger Cancer Institute, we strive to better understand cancer...
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Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
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Cancer Center of Kansas-Independence Dr. H.E. Hynes founded Cancer Center of Kansas, P. A. in...
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800 Prudential Drive
Jacksonville, Florida 32207
Jacksonville, Florida 32207
904.202.2000
Baptist Cancer Institute - Jacksonville For more than 20 years, health care consumers have named...
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Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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100 Provena Way
Kankakee, Illinois 60914
Kankakee, Illinois 60914
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
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Cancer Center of Kansas, PA - Kingman Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1007 LINCOLNWAY
La Porte, Indiana 46350
La Porte, Indiana 46350
219.326.1234
Center for Cancer Therapy at LaPorte Hospital and Health Services United in our mission, the...
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Sparrow Regional Cancer Center Sparrow has grown to become the region's largest health system, and...
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Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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Lewistown Hospital Geisinger-Lewistown Hospital, non-profit organization, is a 123-bed acute care community hospital serving the...
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Cancer Center of Kansas, PA - Liberal Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
Libertyville, Illinois 60048
847-367-6781
North Shore Oncology and Hematology Associates, Limited - Libertyville Welcome to North Shore Oncology and...
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St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
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Littleton Adventist Hospital On April 3, 1989 Littleton Adventist Hospital opened its doors to the...
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St. Mary Mercy Hospital St. Mary Mercy Hospital, located at 36475 Five Mile Road at...
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Sky Ridge Medical Center HealthONE is the largest healthcare system in the metro Denver area...
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1950 Mountain View Ave
Longmont, Colorado 80501
Longmont, Colorado 80501
303.651.5111
Hope Cancer Care Center at Longmont United Hospital Patients treated at the Hope Cancer Care...
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McKee Medical Center Through the years, McKee has led the way in health care innovation....
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2300 Western Ave
Manitowoc, Wisconsin 54221
Manitowoc, Wisconsin 54221
(920) 320-2011
Holy Family Memorial Medical Center Cancer Care Center At the end of the 19th century,...
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Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
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1575 Beam Avenue
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
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3100 Shore Dr.
Marinette, Wisconsin 54143
Marinette, Wisconsin 54143
715.735.6621
Bay Area Cancer Care Center at Bay Area Medical Center The Bay Area Cancer Care...
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Marshfield Clinic - Marshfield Center The Clinic was incorporated under Wisconsin law in 1916 and...
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Saint Joseph's Hospital Our Mission as a Catholic health care system is to further the...
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8800 W. Doyne Avenue
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 805-6840
Medical College of Wisconsin Cancer Center Cancer touches everyone in our community, and for many,...
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800 E 28th St
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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701 Park Ave
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
(612) 873-3000
Hennepin County Medical Center - Minneapolis Hennepin Healthcare System, Inc. operates Hennepin County Medical Center...
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Saint Joseph Regional Medical Center Saint Joseph Regional Medical Center is a not-for-profit, multi-hospital health...
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500 John Deere Road
Moline, Illinois 61265
Moline, Illinois 61265
(309) 779-5000
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Located at 500 John...
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1514 Jefferson Highway
New Orleans, Louisiana 70121
New Orleans, Louisiana 70121
888.624.7637
Ochsner Cancer Institute at Ochsner Clinic Foundation The Ochsner Cancer Institute at Ochsner Clinic Foundation...
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New Ulm Medical Center New Ulm Medical Center is a nonprofit hospital and clinic serving...
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4701 Ogletown-Stanton Road
Newark, Delaware 19713
Newark, Delaware 19713
302-623-4450
CCOP - Christiana Care Health Services Christiana Care's Cancer Research Program is part of a...
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Cancer Center of Kansas, PA - Newton Dr. H.E. Hynes founded Cancer Center of Kansas,...
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8915 W Golf Rd
Niles, Illinois 60714
Niles, Illinois 60714
(847) 827-9060
Cancer Care and Hematology Specialists of Chicagoland - Niles Illinois Cancer Specialists is dedicated to...
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Cancer Center of Kansas, PA - Parsons Dr. H.E. Hynes founded Cancer Center of Kansas,...
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St. Joseph Mercy Oakland St. Joseph Mercy Oakland (SJMO) is a 443-bed comprehensive, community and...
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2601 Electric Ave
Port Huron, Michigan 48060
Port Huron, Michigan 48060
(810) 985-1500
Mercy Regional Cancer Center at Mercy Hospital The Mercy Regional Cancer Center at St. Joseph...
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Cancer Center of Kansas, PA - Pratt Dr. H.E. Hynes founded Cancer Center of Kansas,...
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Spruce St
Reading, Pennsylvania 19611
Reading, Pennsylvania 19611
(484) 628-4357
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Cancer is an unknown...
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2251 North Shore Drive
Rhinelander, Wisconsin 54501
Rhinelander, Wisconsin 54501
715.361.2000
Ministry Medical Group at Saint Mary's Hospital Ministry Saint Mary
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