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 (PIX-R)
This study is currently recruiting participants.
Verified April 2013 by Cell Therapeutics
Sponsor:
Cell Therapeutics
Information provided by (Responsible Party):
Cell Therapeutics
ClinicalTrials.gov Identifier:
NCT01321541
First received: March 21, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large B-cell Lymphoma de Novo DLBCL DLBCL Transformed From Indolent Lymphoma Follicular Grade 3 Lymphoma |
Drug: Pixantrone + Rituximab Drug: Gemcitabine + Rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Cell Therapeutics:
Primary Outcome Measures:
- Overall Survival Analysis [ Time Frame: Randomization through death ] [ Designated as safety issue: No ]OS is defined as the time from randomization until death due to any cause.
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: From randomization to death. ] [ Designated as safety issue: No ]PFS is defined as the time of randomization to the date of PD or death due to any cause (whichever is first reported)
- Complete Response Rate [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]CRR is defined as the proportion of patients who achieve a CR without additional therapy.
- Overall Response Rate [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
- Safety Evaluation [ Time Frame: From randomization to death ] [ Designated as safety issue: No ]The assessment of safety will be mainly on the frequency of adverse events and on the number of laboratory values that fall outside of predetermined ranges.
| Estimated Enrollment: | 350 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pixantrone + Rituximab |
Drug: Pixantrone + Rituximab
Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
|
| Active Comparator: Gemcitabine + Rituximab |
Drug: Gemcitabine + Rituximab
Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
- 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.
- Received rituximab containing a multi-agent therapy for the treatment of NHL.
- Not eligible for high-dose chemotherapy and stem cell transplant.
- Response to NHL treatment for patients with DLBCL transformed from indolent lymphoma.
Exclusion Criteria:
- Primary refractory de novo DLBCL and primary refractory follicular grade 3 lymphoma.
- Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
- Any experimental therapy ≤ 28 days prior to randomization
- 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
- Any contraindication or known allergy or hypersensitivity to any study drugs
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321541
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Contacts
| Contact: Jim Dean, MD PhD | 1-800-215-2355 |
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| United States, Arizona | |
| Arizona Clinical Research Center | Recruiting |
| Tucson, Arizona, United States, 85715 | |
| Contact: Patricia Plezia 520-290-2510 | |
| Principal Investigator: Manuel Modiano, MD | |
| Arizona Oncology Associates | Recruiting |
| Tucson, Arizona, United States, 85745 | |
| Contact: Patricia Plezia 520-290-2510 | |
| Principal Investigator: Manuel Modiano, MD | |
| United States, Arkansas | |
| Highlands Oncology Group | Recruiting |
| Bentonville, Arkansas, United States, 72712 | |
| Contact: Amanda Hall 479-872-8130 | |
| Principal Investigator: J. Thaddeus Beck, MD | |
| Highlands Oncology Group | Recruiting |
| Fayetteville, Arkansas, United States, 72703 | |
| Contact: Amanda Hall 479-872-8130 | |
| Principal Investigator: J. Thaddeus Beck, MD | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | Recruiting |
| Aurora, Colorado, United States, 80012 | |
| Contact: Bobbie Donnachaidh 303-285-5064 | |
| Contact: Susan Syhre 303-285-5064 | |
| Principal Investigator: David Andorsky, MD | |
| Rocky Mountain Cancer Centers | Recruiting |
| Boulder, Colorado, United States, 80303 | |
| Contact: Bobbie Donnachaidh 303-285-5064 | |
| Contact: Susan Syhre 303-285-5064 | |
| Principal Investigator: David Andorsky, MD | |
| Rocky Mountain Cancer Centers | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Bobbie Donnachaidh 303-285-5064 | |
| Contact: Susan Syhre 303-285-5064 | |
| Principal Investigator: David Andorsky, MD | |
| United States, District of Columbia | |
| George Washington University Department of Medicine | Recruiting |
| Washington, District of Columbia, United States, 20037 | |
| Contact: Hiwot Guebre-Xabiher 202-741-2981 hguebrexabiher@mfa.gwu.edu | |
| Principal Investigator: Imad Tabbara, MD | |
| United States, Florida | |
| Integrated Community Oncology Network-St. Vincent's | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Melissa Rammage` 904-519-2731 | |
| Principal Investigator: Mehdi Moezi, MD | |
| Integrated Community Oncology Network-Southside | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Melissa Rammage 904-519-2731 | |
| Principal Investigator: Mehdi Moezi, MD | |
| Integrated Community Oncology Network | Recruiting |
| Orange Park, Florida, United States, 32073 | |
| Contact: Melissa Rammage 904-519-2731 | |
| Principal Investigator: Mehdi Moezi, MD | |
| United States, Georgia | |
| Blood and Marrow Transplant Group of Georgia | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Stacey Brown 404-851-8238 | |
| Principal Investigator: Asad Bashey, MD | |
| United States, Illinois | |
| Carle Physician Group | Recruiting |
| Danville, Illinois, United States, 61832 | |
| Contact: Pauline Mbuvi, SC 217-383-4085 | |
| Principal Investigator: Ronnie E Luyun, MD | |
| Cancer Care Specialists of Central Illinois | Recruiting |
| Decatur, Illinois, United States, 62526 | |
| Contact: Dona Bement 217-876-4760 | |
| Principal Investigator: James Wade, MD | |
| Crossroads Cancer Center | Recruiting |
| Effingham, Illinois, United States, 62401 | |
| Contact: Dona Bement 217-876-4760 | |
| Principal Investigator: James Wade, MD | |
| Carle Foundation Physician Services | Recruiting |
| Mattoon, Illinois, United States, 61938 | |
| Contact: Pauline Mbuvi, SC 217-383-4085 | |
| Principal Investigator: Ronnie E Luyun, MD | |
| Carle Cancer Center | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| Contact: Pauline Mbuvi, SC 217-353-4085 | |
| Principal Investigator: Ronnie E Luyun, MD | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Mary Schall 319-356-3516 | |
| Principal Investigator: Brian Link, MD | |
| United States, Kansas | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67215 | |
| Contact: Renee Schott 316-613-4314 | |
| Principal Investigator: Shaker Dakhil, MD | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67208 | |
| Contact: Renee Schott 316-613-4314 | |
| Principal Investigator: Shaker Dakhil, MD | |
| United States, Kentucky | |
| Baptist Hospital East | Recruiting |
| Louisville, Kentucky, United States, 40207 | |
| Contact: Gina Bowling 502-897-1166 | |
| Principal Investigator: Leela Bhupalam, MD | |
| United States, Maryland | |
| Harry and Jeanette Weinberg Cancer Institute at Franklin Square | Recruiting |
| Baltimore, Maryland, United States, 21237 | |
| Contact: Jean Flack 443-777-7364 | |
| Principal Investigator: Sien Aung, MD | |
| Center for Cancer and Blood Disorders, PC | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Contact: Natalie Bongiorno 301-571-2016 | |
| Principal Investigator: Victor Priego, MD | |
| United States, Michigan | |
| Cancer & Hematology Center of Western Michigan | Recruiting |
| Grand Rapids, Michigan, United States, 49450 | |
| Contact: Kathy Estkowski, BS, CCRP 616-977-4878 | |
| Principal Investigator: Timothy O'Rourke, MD | |
| United States, Minnesota | |
| Metro Minnesota CCOP-Unity Hospital | Recruiting |
| Fridley, Minnesota, United States, 55432 | |
| Contact: Alanna Gibbs 952-993-1545 | |
| Principal Investigator: Daniel M Anderson, MD | |
| Metro Minnesota CCOP-St. Johns | Recruiting |
| Maplewood, Minnesota, United States, 55109 | |
| Contact: Stephanie Erickson, RN 952-993-3252 stephanie.erickson@parknicollet.com | |
| Principal Investigator: Daniel M Anderson, MD | |
| Metro Minnesota Community Clinical Oncology Program | Recruiting |
| St. Louis Park, Minnesota, United States, 55416 | |
| Contact: Stephanie Erickson, RN 952-993-3252 stephanie.erickson@parknicollet.com | |
| Principal Investigator: Daniel M Anderson, MD | |
| Metro Minnesota Community Clinical Oncology Program | Recruiting |
| St. Louis Park, Minnesota, United States, 55426 | |
| Contact: Stephanie Erickson, RN 952-993-3252 stephanie.erickson@parknicollet.com | |
| Principal Investigator: Daniel M Anderson, MD | |
| Metro Minnesota CCOP-Regions Hospital | Recruiting |
| St. Paul, Minnesota, United States, 55101 | |
| Contact: Stephanie Erickson, RN 952-993-3252 stephanie.erickson@parknicollet.com | |
| Principal Investigator: Daniel M Anderson, MD | |
| United States, Missouri | |
| Missouri Cancer Associates | Active, not recruiting |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| Nebraska Hematology-Oncology, PC | Recruiting |
| Lincoln, Nebraska, United States, 68506 | |
| Contact: Sue Ortiz 402-484-4907 | |
| Principal Investigator: Madhu Midathada, MD | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89148 | |
| Contact: Arva Hubbard 702-952-1251 ext 1277 | |
| Principal Investigator: Regan C Holdridge, MD | |
| Comprehensive Cancer Centers of Nevada | Recruiting |
| Las Vegas, Nevada, United States, 89169 | |
| Contact: Arva Hubbard 702-952-1251 ext 1277 | |
| Principal Investigator: Regan C Holdridge, MD | |
| United States, New Jersey | |
| Hematology-Oncology Associates of Northern New Jersey | Recruiting |
| Morristown, New Jersey, United States, 07962 | |
| Contact: Michelle MacKenzie 973-538-3593 ext 2338 | |
| Principal Investigator: Charles Farber, MD | |
| United States, New York | |
| North Shore Hematology/Oncology Associates | Recruiting |
| East Setauket, New York, United States, 11733 | |
| Contact: Loretta Pierzchanowski 631-751-3000 ext 170 | |
| Principal Investigator: Jeffrey Vacirca, MD | |
| United States, Ohio | |
| Gabrail Cancer Center | Recruiting |
| Canton, Ohio, United States, 44718 | |
| Contact: Carrie Smith 330-492-3345 ext 208 | |
| Principal Investigator: Nashat Gabrail, MD | |
| Dayton Clinical Oncology Program | Recruiting |
| Dayton, Ohio, United States, 45420 | |
| Contact: Cara Nolan 937-775-1354 | |
| Principal Investigator: Howard Gross, MD | |
| Dayton Physicians, LLC | Recruiting |
| Dayton, Ohio, United States, 45415 | |
| Contact: Cara Nolan 937-775-1354 | |
| Principal Investigator: Howard Gross, MD | |
| Gabrail Cancer Center | Recruiting |
| Dover, Ohio, United States, 44622 | |
| Contact: Carrie Smith 330-492-3345 ext 208 | |
| Principal Investigator: Nashat Gabrail, MD | |
| Dayton Physicians, LLC | Recruiting |
| Kettering, Ohio, United States, 45409 | |
| Contact: Cara Nolan 937-775-1354 | |
| Principal Investigator: Howard Gross, MD | |
| Toledo Clinical Cancer Center | Recruiting |
| Toledo, Ohio, United States, 43617 | |
| Contact: Joanne Lenkay 419-843-6147 ext 228 | |
| Principal Investigator: Rex Mowat, MD | |
| Toledo Clinic Cancer Center-Toledo | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Joanne Lenkay 419-843-6147 ext 228 | |
| Principal Investigator: Rex Mowat, MD | |
| Mercy Cancer Center at St. Anne's | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| Contact: Joanne Lenkay 419-843-6147 ext 228 | |
| Principal Investigator: Rex Mowat, MD | |
| United States, Oregon | |
| Northwest Cancer Specialists, PC | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Tamyr Batsch 360-597-1061 | |
| Principal Investigator: Kathryn Kolibaba, MD | |
| Northwest Cancer Specialists, PC | Recruiting |
| Portland, Oregon, United States, 97225 | |
| Contact: Tamyr Batsch 360-597-1061 | |
| Principal Investigator: Kathryn Kolibaba, MD | |
| Northwest Cancer Specialists, PC | Recruiting |
| Tualatin, Oregon, United States, 97062 | |
| Contact: Tamyr Batsch 360-597-1061 | |
| Principal Investigator: Kathryn Kolibaba, MD | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Linda Thibodeau 215-728-2207 | |
| Principal Investigator: Adam Cohen, MD | |
| United States, South Carolina | |
| Upstate Oncology Associates | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Contact: Kristina Stoeppler-Biege 864-255-1517 | |
| Principal Investigator: Gary Spitzer, MD | |
| South Carolina Cancer Specialists | Recruiting |
| Hardeeville, South Carolina, United States, 29927 | |
| Contact: Becky McCunn 843-689-9267 | |
| Principal Investigator: Gary Thomas, MD | |
| South Carolina Cancer Specialists | Recruiting |
| Hilton Head Island, South Carolina, United States, 29926 | |
| Contact: Becky McCunn 843-689-9267 | |
| Principal Investigator: Gary Thomas, MD | |
| United States, Texas | |
| Joe Arrington Cancer Research and Treatment Center | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Patti Ortiz 806-725-8065 | |
| Principal Investigator: Donald Quick, MD | |
| Cancer Care Centers of South Texas-HOAST | Recruiting |
| New Braunfels, Texas, United States, 78130 | |
| Contact: Joanne Hardy 210-595-5683 | |
| Principal Investigator: Roger M Lyons, MD | |
| Cancer Care Centers of South Texas-HOAST | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Joanne Hardy 210-595-5683 | |
| Principal Investigator: Roger M Lyons, MD | |
| United States, Virginia | |
| Blue Ridge Cancer Care | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
| Contact: Shary Lavoie 540-982-0237 ext 1806 | |
| Principal Investigator: Lowell F Inhorn, MD | |
| United States, Washington | |
| Northwest Cancer Specialists, PC | Recruiting |
| Vancouver, Washington, United States, 98684 | |
| Contact: Tamyr Batsch 360-597-1061 | |
| Principal Investigator: Kathryn Kolibaba, MD | |
| Northwest Cancer Specialists, PC | Recruiting |
| Vancouver, Washington, United States, 98686 | |
| Contact: Tamyr Batsch 360-597-1061 | |
| Principal Investigator: Kathryn Kolibaba, MD | |
| United States, Wisconsin | |
| Saint Vincent Hospital Green Bay Oncology | Recruiting |
| Green Bay, Wisconsin, United States, 54301 | |
| Contact: Jolene Cheslock 920-433-8889 | |
| Principal Investigator: Anthony Jaslowski, MD | |
| Green Bay Oncology-St. Mary's Hospital MC | Recruiting |
| Green Bay, Wisconsin, United States, 54303 | |
| Contact: Jolene Cheslock 920-433-8889 | |
| Principal Investigator: Anthony Jaslowski, MD | |
Sponsors and Collaborators
Cell Therapeutics
More Information
Additional Information:
No publications provided
| Responsible Party: | Cell Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01321541 History of Changes |
| Other Study ID Numbers: | PIX306 (PIX-R Trial) |
| Study First Received: | March 21, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cell Therapeutics:
|
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 |
Additional relevant MeSH terms:
|
Aggression Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Behavioral Symptoms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Pixantrone |
Rituximab Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Topoisomerase II Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013