Trial record 1 of 1 for:    S1106
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S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Southwest Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01412879
First received: August 6, 2011
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy also work in different ways to kill more cancer cells or stop them from growing. It is not yet known whether rituximab is more effective with combination chemotherapy or bendamustine hydrochloride in treating patients with mantle cell lymphoma undergoing peripheral blood stem cell transplantation.

PURPOSE: This randomized phase II trial studies how well giving rituximab together with combination chemotherapy or bendamustine hydrochloride followed by consolidation chemotherapy and peripheral blood stem cell transplantation works in treating older patients with previously untreated mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: bendamustine hydrochloride
Drug: cyclophosphamide
Drug: cytarabine
Drug: dexamethasone
Drug: doxorubicin hydrochloride
Drug: leucovorin calcium
Drug: methotrexate
Drug: vincristine sulfate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial of R-HCVAD/MTX/ARA-C Induction Followed by Consolidation With an Autologous Stem Cell Transplant Vs. R-Bendamustine Induction Followed by Consolidation With an Autologous Stem Cell Transplant for Patients ≤ 65 Years of Age With Previously Untreated Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • PFS at 2 years [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.


Secondary Outcome Measures:
  • Toxicity of R-HCVAD/MTX/Ara-C and autologous stem cell transplant (ASCT) or R-bendamustine and ASCT [ Time Frame: Up to 9 months ] [ Designated as safety issue: Yes ]
    Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.

  • Response rate (complete and partial response) [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Complete Response (CR) is a complete disappearance of all disease with the exception of the following. If no PET scan or when the PET scan was positive before therapy, a post-treatment residual mass of any size is permitted if it is PET negative. If the PET scan was negative before therapy, all nodal masses at baseline must have regressed. No new lesions. Previously enlarged organs must have regressed and not be palpable. Bone marrow (BM) must be negative if positive at baseline. Normalization of markers. Partial Response (PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. If PET scan or when the PET scan was positive before therapy, PET should be positive in at least one previously involved site.

  • Overall survival [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    Measured from date of registration to date of death due to any cause. Patients last known to be alive and are censored at date of last contact.


Estimated Enrollment: 180
Study Start Date: November 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Course 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Course 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients then undergo stem cell collection after completion of course 2. Patients undergo stem cell collection after completion of course 2.
Biological: rituximab
Given IV
Drug: cyclophosphamide
Given IV
Drug: cytarabine
Given IV
Drug: dexamethasone
Given PO or IV
Drug: doxorubicin hydrochloride
Given IV
Drug: leucovorin calcium
Given PO or IV
Drug: methotrexate
Given IV
Drug: vincristine sulfate
Given IV
Experimental: Arm II
Course 1-6: Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-4 weeks later, patients with responsive disease receive 2 additional courses of treatment. Beginning within 8 weeks, patients receive rituximab IV and cyclophosphamide IV over 1 hour on day 1. Patients then undergo stem cell collection about 26 days later.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: cyclophosphamide
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • All patients must have previously untreated stage III, IV, or bulky stage II mantle cell lymphoma (MCL)

    • A diagnosis of MCL must be confirmed by histopathological diagnosis including immunohistochemistry and flow cytometry documenting both of the following phenotypes:

      • CD19+ or CD20+
      • Cyclin D1+ or evidence of the t(11;14) translocation by cytogenetics or FISH
  • Adequate sections from the original diagnostic specimen must be available for submission for central review

    • An adequate biopsy requires sufficient tissue to establish the architecture and a WHO histologic subtype with certainty

      • Core biopsies, especially multiple core biopsies, MAY be adequate, but needle aspirations or cytologies are not adequate
    • Bone marrow core biopsy or clot sections (not aspirates) may be used as diagnostic material if it is significantly involved and are the only diagnostic material available
  • All patients must have bidimensional measurable disease documented on the Lymphoma Baseline Tumor Assessment Form (Form #48031)

    • Patients who also have non-measurable disease in addition to measurable disease must have all nonmeasurable disease assessed within 28 days prior to registration
  • Patients must not have clinical evidence of central nervous system (CNS) involvement by lymphoma

    • Any laboratory or radiographic tests performed prior to registration to assess CNS involvement must be negative
  • Patients must have a unilateral/bilateral bone marrow aspirate and biopsy for staging performed within 42 days prior to registration

    • If the biopsy cannot be performed but the aspirate is unequivocally consistent with mantle cell lymphoma, this will be considered adequate for staging purposes
  • Patients must be eligible for stem cell transplantation by institutional guidelines with the plan that transplant will be conducted at a cooperative group-approved transplant center

    • Patients must be planning to undergo stem cell transplantation within 84 days after day 1 of the last induction course
    • Patients must have had at least 1.5 X 10^6 CD34^+ cells/kg collected and stored prior to second registration for stem cell transplantation

PATIENT CHARACTERISTICS:

  • Zubrod performance status of 0-2
  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • Serum creatinine ≤ 2.0 times ULN
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Platelet count ≥ 100,000/mcL, unless due to bone marrow infiltration by lymphoma
  • All patients ≥ 45 years of age must have an echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA )scan within 42 days prior to registration (whichever method is used at baseline must be used at restaging)

    • Patients < 45 years of age should have ECHO/MUGA only if clinically indicated
    • Patients with an ejection fraction < institutional lower limit of normal (ILLN) are not eligible
  • Serum Lactate dehydrogenase (LDH) and a Complete Blood Count (CBC with differential must be measured within 28 days prior to registration
  • Patients known to be HIV positive, or who have a history of solid organ transplantation, are ineligible
  • No active hepatitis
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; adequately treated Stage I or II cancer from which the patient is currently in complete remission; or any other cancer from which the patient has been disease-free for 5 years
  • Pregnant or nursing women may not participate
  • Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412879

Contacts
Contact: Megan Hardin 2106148808 ext 1014 mhardin@swog.org
Contact: Dana B Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Hide Study Locations
Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen    800-826-4673    becomingapatient@coh.org   
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital    303-938-5253      
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen    303-839-6000      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center    303-403-3605      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Florida
Florida Hospital Cancer Institute at Florida Hospital Orlando Recruiting
Orlando, Florida, United States, 32803-1273
Contact: Clinical Trials Office - Florida Hospital Cancer Institute    407-303-5623      
United States, Idaho
St. Joseph Regional Medical Center Recruiting
Lewiston, Idaho, United States, 83501
Contact: Yoshio Inoue    208-743-2511      
United States, Illinois
Illinois CancerCare - Bloomington Recruiting
Bloomington%, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Illinois CancerCare - Canton Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Graham Hospital Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Memorial Hospital Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-3131      
Illinois CancerCare - Carthage Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-6877      
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates    312-695-1301      
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Illinois CancerCare - Eureka Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Illinois CancerCare - Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-9269      
Mason District Hospital Recruiting
Havana, Illinois, United States, 62644
Contact: Nguyet A. Le-Lindqwister    309-543-4431      
Illinois CancerCare - Havana Recruiting
Havana, Illinois, United States, 62644
Contact: Nguyet A. Le-Lindqwister    309-543-8557      
Kellogg Cancer Care Center Recruiting
Highland Park, Illinois, United States, 60035
Contact: Jane N. Winter, MD    312-695-4538      
Provena St. Mary's Regional Cancer Center - Kankakee Recruiting
Kankakee, Illinois, United States, 60901
Contact: Jane N. Winter, MD    312-695-4538      
Illinois CancerCare - Kewanee Clinic Recruiting
Kewanee, Illinois, United States, 61443
Contact: Nguyet A. Le-Lindqwister    309-852-0598      
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Jane N. Winter, MD    312-695-4538      
Illinois CancerCare - Macomb Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-3503      
McDonough District Hospital Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-4101      
Cardinal Bernardin Cancer Center at Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center    708-226-4357      
Illinois CancerCare - Monmouth Recruiting
Monmouth, Illinois, United States, 61462
Contact: Nguyet A. Le-Lindqwister    309-734-3141      
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Jane N. Winter, MD    312-695-4538      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-454-1400      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-451-8500      
Illinois CancerCare - Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-662-2102      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-433-3100      
Oncology Hematology Associates of Central Illinois, PC - Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-431-9270      
Illinois CancerCare - Pekin Recruiting
Pekin, Illinois, United States, 61603
Contact: Nguyet A. Le-Lindqwister    309-353-0214      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    309-353-0512      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3000      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    309-691-1000      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-223-3000      
Illinois CancerCare - Peru Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-780-3185      
Illinois CancerCare - Princeton Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    815-875-3010      
Perry Memorial Hospital Recruiting
Princeton, Illinois, United States, 61356
Contact: Nguyet A. Le-Lindqwister    815-875-2811      
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Jane N. Winter, MD    312-695-4538      
Illinois CancerCare - Spring Valley Recruiting
Spring Valley, Illinois, United States, 61362
Contact: Nguyet A. Le-Lindqwister    815-664-1487      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - McPherson Recruiting
McPherson, Kansas, United States, 67460
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Clinical Trials Office - Markey Cancer Center at University of    859-257-3379      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Frank Beardell, MD    302-737-7700      
United States, Michigan
Hickman Cancer Center at Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Clinical Trials Office - Hickman Cancer Center at Bixby Medica    517-265-0116      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
Mercy Memorial Hospital - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    734-240-8400      
United States, Minnesota
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Patrick J. Flynn, MD    612-884-6300      
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Patrick J. Flynn, MD    612-884-6300      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Patrick J. Flynn, MD    612-884-6300      
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Patrick J. Flynn, MD    612-884-6300      
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD    612-884-6300      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Patrick J. Flynn, MD    612-884-6300      
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn    612-873-5911      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Patrick J. Flynn, MD    612-884-6300      
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor    763-520-1893      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD    612-884-6300      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Patrick J. Flynn, MD    612-884-6300      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Patrick J. Flynn, MD    612-884-6300      
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Patrick J. Flynn, MD    612-884-6300      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Patrick J. Flynn, MD    612-884-6300      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Patrick J. Flynn, MD    612-884-6300      
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Patrick J. Flynn, MD    612-884-6300      
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Patrick J. Flynn, MD    612-884-6300      
United States, Missouri
Saint Louis University Cancer Center Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Clinical Trials Office - Saint Louis University Cancer Center    314-977-4440      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD    314-362-5654      
United States, New Jersey
Cancer Institute of New Jersey at Hamilton Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham    609-631-6946      
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey    732-235-8675      
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, Ohio
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross, MD    937-832-1093      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
Community Cancer Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Contact Person    440-324-0400      
Hematology Oncology Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Rex B. Mowat    440-324-0401      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext 57556      
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Rex B. Mowat    419-228-3335      
Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537-1839
Contact: Rex B. Mowat    419-891-5600      
St. Charles Mercy Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    419-696-7200      
North Coast Cancer Care, Incorporated Recruiting
Sandusky, Ohio, United States, 44870
Contact: Rex B. Mowat    419-626-9090      
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center    419-824-1842      
Mercy Hospital of Tiffin Recruiting
Tiffin, Ohio, United States, 44883
Contact: Rex B. Mowat    419-447-3130      
Medical University of Ohio Cancer Center Recruiting
Toledo, Ohio, United States, 43614
Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen    419-383-6583      
Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Clinical Trials Office - Toledo Hospital    419-824-1842      
St. Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    419-407-2663      
St. Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Rex B. Mowat    419-251-4515      
Toledo Clinic, Incorporated - Main Clinic Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    419-479-5605      
CCOP - Toledo Community Hospital Recruiting
Toledo, Ohio, United States, 43617
Contact: Contact Person    419-843-6147      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Clinical Trials Office - Fulton County Health Center    419-330-2708      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Contact: Stacy K. Lewis    503-513-3300      
Providence Milwaukie Hospital Recruiting
Milwaukie, Oregon, United States, 97222
Contact: Stacy K. Lewis    503-513-8300      
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Contact: Stacy K. Lewis    503-537-1555      
Willamette Falls Hospital Recruiting
Oregon City, Oregon, United States, 97045
Contact: Stacy K. Lewis    503-650-6758      
CCOP - Columbia River Oncology Program Recruiting
Portland, Oregon, United States, 97225
Contact: Stacy K. Lewis    503-216-6260      
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Clinical Trials Office - Providence St. Vincent Medical Center    503-215-6412      
Providence Cancer Center at Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213-2967
Contact: Clinical Trials Office - Providence Cancer Center at Providenc    503-215-6412      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Edward J. Gorak, II    570-459-2901      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Edward J. Gorak, II    814-231-4560      
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce    570-271-5251      
United States, South Carolina
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: Suzanne R. Fanning    864-679-3900      
Greenville Hospital Cancer Center Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Greenville Hospital Cancer Center    864-241-6251      
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Clinical Trials Office - Cancer Centers of the Carolinas    864-241-6251      
CCOP - Greenville Recruiting
Greenville, South Carolina, United States, 29615
Contact: Suzanne R. Fanning    864-241-6251      
Cancer Centers of the Carolinas - Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: Suzanne R. Fanning    864-662-4000      
Cancer Centers of the Carolinas - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Suzanne R. Fanning    864-888-3717      
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Suzanne R. Fanning    864-699-5700      
United States, Texas
Baylor University Medical Center - Dallas Recruiting
Dallas, Texas, United States, 75246
Contact: Clinical Trials Office - Baylor University Medical Center - Da    800-422-9567      
United States, Virginia
Fredericksburg Oncology, Incorporated Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Rex B. Mowat    540-368-0500      
United States, Washington
Island Hospital Cancer Care Center at Island Hospital Recruiting
Anacortes, Washington, United States, 98221
Contact: Saul E. Rivkin, MD    206-386-2441      
Overlake Cancer Center at Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Yoshio Inoue    425-454-2148      
St. Joseph Cancer Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Saul E. Rivkin, MD    206-386-2441      
Olympic Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Saul E. Rivkin, MD    206-386-2441      
Highline Medical Center Cancer Center Recruiting
Burien, Washington, United States, 98166
Contact: Saul E. Rivkin, MD    206-386-2441      
Providence Centralia Hospital Recruiting
Centralia, Washington, United States, 98531-9027
Contact: Clinical Trials Office - Providence Centralia H    360-493-4300      
Providence Regional Cancer Partnership Recruiting
Everett, Washington, United States, 98201
Contact: Yoshio Inoue    425-297-5500      
St. Francis Hospital Recruiting
Federal Way, Washington, United States, 98003
Contact: Yoshio Inoue    253-944-7997      
Swedish Medical Center - Issaquah Campus Recruiting
Issaquah, Washington, United States, 98029
Contact: Saul E. Rivkin, MD    206-386-2441      
Columbia Basin Hematology Recruiting
Kennewick, Washington, United States, 99336
Contact: Saul E. Rivkin, MD    206-386-2441      
Skagit Valley Hospital Cancer Care Center Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Saul E. Rivkin, MD    206-386-2441      
Providence St. Peter Hospital Regional Cancer Center Recruiting
Olympia, Washington, United States, 98506-5166
Contact: Yoshio Inoue    360-493-7514      
Harrison Poulsbo Hematology and Onocology Recruiting
Poulsbo, Washington, United States, 98370
Contact: Saul E. Rivkin, MD    206-386-2441      
Good Samaritan Cancer Center Recruiting
Puyallup, Washington, United States, 98372
Contact: Yoshio Inoue    253-697-4000      
Minor and James Medical, PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD    206-386-2441      
Group Health Central Hospital Recruiting
Seattle, Washington, United States, 98112
Contact: Clinical Trials Office - Group Health Central Hospital    206-287-2900      
University Cancer Center at University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Saul E. Rivkin, MD    206-386-2441      
Polyclinic First Hill Recruiting
Seattle, Washington, United States, 98122
Contact: Saul E. Rivkin, MD    206-386-2441      
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Saul E. Rivkin, MD    206-386-2441      
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Saul E. Rivkin, MD    206-386-2441      
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Saul E. Rivkin, MD    206-386-2441      
North Puget Oncology at United General Hospital Recruiting
Sedro-Woolley, Washington, United States, 98284
Contact: Saul E. Rivkin, MD    206-386-2441      
Evergreen Hematology and Oncology, PS Recruiting
Spokane, Washington, United States, 99218
Contact: Saul E. Rivkin, MD    206-386-2441      
Cancer Care Northwest - Spokane South Recruiting
Spokane, Washington, United States, 99202
Contact: Clinical Trials Office - Cancer Care Northwest - Spokane South    509-228-1083      
CCOP - Northwest Recruiting
Tacoma, Washington, United States, 98405
Contact: Yoshio Inoue    253-403-1461      
St. Clare Hospital Recruiting
Tacoma, Washington, United States, 98499
Contact: Yoshio Inoue    253-588-1711      
Franciscan Cancer Center at St. Joseph Medical Center Recruiting
Tacoma, Washington, United States, 98405-3004
Contact: Clinical Trials Office - Franciscan Cancer Center    253-426-6914      
MultiCare Regional Cancer Center at Tacoma General Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Clinical Trials Office - MultiCare Regional Cancer Center    253-403-3229      
Allenmore Hospital Recruiting
Tacoma, Washington, United States, 98405
Contact: Yoshio Inoue    253-459-6446      
Northwest Cancer Specialists at Vancouver Cancer Center Recruiting
Vancouver, Washington, United States, 98684
Contact: Stacy K. Lewis    360-944-9889      
Southwest Washington Medical Center Cancer Center Recruiting
Vancouver, Washington, United States, 98664
Contact: Stacy K. Lewis    360-514-2174      
Wenatchee Valley Medical Center Recruiting
Wenatchee, Washington, United States, 98801-2028
Contact: Clinical Trials Office - Wenatchee Valley Medical Center    509-665-5800      
United States, West Virginia
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mehdi Hamadani    304-293-4500      
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Steven H. Bernstein, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01412879     History of Changes
Other Study ID Numbers: CDR0000707601, S1106, U10CA032102
Study First Received: August 6, 2011
Last Updated: February 17, 2014
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Cytarabine
Methotrexate
Rituximab
Nitrogen Mustard Compounds
Bendamustine
Dexamethasone
Doxorubicin
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Leucovorin
Levoleucovorin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on July 20, 2014