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A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-cell Lymphoma, de Novo DLBCL, DLBCL Transformed From Indolent Lymphoma, Follicular Grade 3 Lymphoma

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Trial Information

A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant


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. Response to NHL treatment for patients with DLBCL transformed from indolent lymphoma.

Exclusion Criteria:

1. Primary refractory de novo DLBCL and primary refractory follicular grade 3 lymphoma.

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival Analysis

Outcome Description:

OS is defined as the time from randomization until death due to any cause.

Outcome Time Frame:

Randomization through death

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PIX306 (PIX-R Trial)

NCT ID:

NCT01321541

Start Date:

April 2011

Completion Date:

June 2017

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • de Novo DLBCL
  • DLBCL Transformed From Indolent Lymphoma
  • Follicular Grade 3 Lymphoma
  • non-hodgkin lymphoma
  • DLBCL
  • relapsed
  • aggressive NHL
  • Diffuse large B-cell lymphoma
  • Rituximab
  • Rituxan
  • Pixantrone
  • NHL
  • non hodgkin's lymphoma
  • de novo DLBCL
  • DLBCL transformed from Indolent Lymphoma
  • Follicular Grade 3 Lymphoma
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular

Name

Location

University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Joe Arrington Cancer Research and Treatment Center Lubbock, Texas  79410-1894
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Carle Cancer Center Urbana, Illinois  61801
Missouri Cancer Associates Columbia, Missouri  65201
Crossroads Cancer Center Effingham, Illinois  62401
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Arizona Clinical Research Center Tucson, Arizona  85712
Highlands Oncology Group Springdale, Arkansas  72764
Integrated Community Oncology Network Jacksonville Beach, Florida  32250
Blood and Marrow Transplant Group of Georgia Atlanta, Georgia  30342-1601
Arizona Oncology Associates Tucson, Arizona  85712-2254
Gabrail Cancer Center Canton, Ohio  44718
Dayton Clinical Oncology Program Dayton, Ohio  45420
Cancer Center of Kansas Wichita, Kansas  67214
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Hematology-Oncology Associates of Northern New Jersey Morristown, New Jersey  07962
South Carolina Cancer Specialists Hilton Head Island, South Carolina  29925
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Nebraska Hematology-Oncology, PC Lincoln, Nebraska  68506
Baptist Hospital East Louisville, Kentucky  40207
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Baltimore, Maryland  21237
Center for Cancer and Blood Disorders, PC Bethesda, Maryland  20817
Northwest Cancer Specialists, PC Portland, Oregon  97225
Cancer Care Centers of South Texas-HOAST San Antonio, Texas  78229
North Shore Hematology/Oncology Associates East Setauket, New York  
Blue Ridge Cancer Care Roanoke, Virginia  24019
Metro Minnesota Community Clinical Oncology Program St. Louis Park, Minnesota  
George Washington University Department of Medicine Washington, District of Columbia  20037
Integrated Community Oncology Network-St. Vincent's Jacksonville, Florida  32204
Integrated Community Oncology Network-Southside Jacksonville, Florida  32207
Carle Physician Group Danville, Illinois  61832
Carle Foundation Physician Services Mattoon, Illinois  61938
Cancer & Hematology Center of Western Michigan Grand Rapids, Michigan  49450
Metro Minnesota CCOP-Unity Hospital Fridley, Minnesota  55432
Metro Minnesota CCOP-St. Johns Maplewood, Minnesota  55109
Metro Minnesota CCOP-Regions Hospital St. Paul, Minnesota  55101
Dayton Physicians, LLC Dayton, Ohio  45415
Toledo Clinical Cancer Center Toledo, Ohio  43617
Toledo Clinic Cancer Center-Toledo Toledo, Ohio  43623
Mercy Cancer Center at St. Anne's Toledo, Ohio  43623
Upstate Oncology Associates Greenville, South Carolina  29615
Saint Vincent Hospital Green Bay Oncology Green Bay, Wisconsin  54301
Green Bay Oncology-St. Mary's Hospital MC Green Bay, Wisconsin  54303