Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant



Status:Completed
Conditions:Lymphoma, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/19/2018
Start Date:April 20, 2011
End Date:September 14, 2018

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A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to
Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL), or follicular grade 3 lymphoma.

Eligible patients will be randomized to treatment with pixantrone plus rituximab or
gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience
progressive disease during study treatment, early follow- up, or intermediate follow-up, they
enter the survival follow up period. Patients who complete study treatment or discontinue
study treatment for any other reason will participate in the follow-up periods.

Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week
follow-up period.

Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will
enter an additional 72-week follow-up period.

Survival Follow-Up: All patients will be monitored for survival.

Inclusion Criteria:

1. Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or
follicular grade 3 lymphoma on the basis of tissue biopsy.

2. Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL.
Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens
for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent
lymphoma must have received at least 1-4 treatment regimens for NHL.

3. Received rituximab containing a multi-agent therapy for the treatment of NHL.

4. Not eligible for high-dose chemotherapy and stem cell transplant.

5. Patients with DLBCL transformed from indolent lymphoma must have had a complete or
partial response to a therapy for NHL lasting at least 12 weeks.

Exclusion Criteria:

1. Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma,
defined as documented progression within 12 weeks of the last cycle of the first-line
multi-agent regimen.

2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2

3. Any experimental therapy ≤ 28 days prior to randomization

4. Other malignancy within last 5 years except for the following: curatively treated
basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial
transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after
complete resection

5. Any contraindication or known allergy or hypersensitivity to any study drugs

6. Concomitant therapy with any anticancer agents, immunosuppressive agents, other
investigational anticancer therapies. Low-dose corticosteroids for the treatment of
non cancer-related illnesses are permitted.
We found this trial at
51
sites
Aurora, Colorado 80012
Principal Investigator: David Andorsky, MD
Phone: 303-285-5064
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Bentonville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck, MD
Phone: 479-872-8130
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Principal Investigator: Victor Priego, MD
Phone: 301-571-2016
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Boulder, Colorado 80303
Principal Investigator: David Andorsky, MD
Phone: 303-285-5064
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4875 Higbee Ave NW
Canton, Ohio 44718
330-492-3345
Principal Investigator: Nashat Gabrail, MD
Gabrail Cancer Center Since 1990, Gabrail Cancer Center has built a national reputation for excellence...
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Columbia, Missouri 65201
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Danville, Illinois 61832
Principal Investigator: James Egner, MD
Phone: 217-383-4085
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Decatur, Illinois 62526
Principal Investigator: James Wade, MD
Phone: 217-876-4758
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Denver, Colorado 80218
Principal Investigator: David Andorsky, MD
Phone: 303-285-5064
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Dover, Ohio 44622
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
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East Setauket, New York 11733
Principal Investigator: Jeffrey Vacirca, MD
Phone: 631-751-3000
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Effingham, Illinois 62401
Principal Investigator: James Wade, MD
Phone: 217-876-4758
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Fayetteville, Arkansas 72703
Principal Investigator: J. Thaddeus Beck, MD
Phone: 479-872-8130
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Fridley, Minnesota 55432
Principal Investigator: Daniel M Anderson, MD
Phone: 952-993-3252
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Grand Rapids, Michigan 49450
Principal Investigator: Timothy O'Rourke, MD
Phone: 616-954-5550
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Green Bay, Wisconsin 54301
Principal Investigator: Anthony Jaslowski, MD
Phone: 920-433-8889
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Green Bay, Wisconsin 54303
Principal Investigator: Anthony Jaslowski, MD
Phone: 920-433-8889
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Greenville, South Carolina 29615
Principal Investigator: Fahd Quddus, MD
Phone: 864-255-1517
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Hardeeville, South Carolina 29927
Principal Investigator: Gary Thomas, MD
Phone: 843-689-9267
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Hilton Head Island, South Carolina 29926
Principal Investigator: Gary Thomas, MD
Phone: 843-689-9267
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Lincoln, Nebraska 68506
Principal Investigator: Madhu Midathada, MD
Phone: 402-484-4907
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Louisville, Kentucky 40207
Principal Investigator: Leela Bhupalam, MD
Phone: 502-897-1166
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Lubbock, Texas 79410
Principal Investigator: Donald Quick, MD
Phone: 806-725-8065
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Maplewood, Minnesota 55109
Principal Investigator: Daniel M Anderson, MD
Phone: 952-993-3252
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Mattoon, Illinois 61938
Principal Investigator: James Egner, MD
Phone: 217-383-4085
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Morristown, New Jersey 07962
Principal Investigator: Charles Farber, MD
Phone: 973-538-3593
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New Braunfels, Texas 78130
Principal Investigator: Roger M Lyons, MD
Phone: 210-595-5324
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Orange Park, Florida 32073
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Philadelphia, Pennsylvania 19111
Principal Investigator: Stefan Barta, MD
Phone: 215-728-2207
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Portland, Oregon 97213
Principal Investigator: Kathryn Kolibaba, MD
Phone: 360-597-1061
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Portland, Oregon 97213
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Roanoke, Virginia 24014
Principal Investigator: Jennifer Vaughn, MD
Phone: 540-982-0237
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Saint Louis Park, Minnesota 55416
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640 Jackson Street
Saint Paul, Minnesota 55101
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San Antonio, Texas 78229
Principal Investigator: Roger M Lyons, MD
Phone: 210-595-5324
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Toledo, Ohio 43617
Principal Investigator: Rex Mowat, MD
Phone: 419-843-6147
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Toledo, Ohio 43623
Principal Investigator: Rex Mowat, MD
Phone: 419-843-6147
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Toledo, Ohio 43623
Principal Investigator: Rex Mowat, MD
Phone: 419-843-6147
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Tualatin, Oregon 97062
Principal Investigator: Kathryn Kolibaba, MD
Phone: 360-597-1061
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Tucson, Arizona 85712
Principal Investigator: Manuel Modiano, MD
Phone: 520-290-2510
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Tucson, Arizona 85745
Principal Investigator: Manuel Modiano, MD
Phone: 520-290-2510
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602 W University Ave
Urbana, Illinois 61801
(217) 383-3010
Principal Investigator: James Egner, MD
Phone: 217-353-4085
Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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Vancouver, Washington 98684
Principal Investigator: Kathryn Kolibaba, MD
Phone: 360-597-1061
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Vancouver, Washington 98684
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Washington, District of Columbia 20037
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Principal Investigator: Shaker Dakhil, MD
Phone: 316-613-4314
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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