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)
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ClinicalTrials.gov Identifier: NCT01321541 |
Recruitment Status :
Completed
First Posted : March 23, 2011
Results First Posted : November 19, 2021
Last Update Posted : November 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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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 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 312 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (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 Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant |
Actual Study Start Date : | April 20, 2011 |
Actual Primary Completion Date : | June 28, 2018 |
Actual Study Completion Date : | September 14, 2018 |

Arm | Intervention/treatment |
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Experimental: Pixantrone + Rituximab
Pixantrone and Rituximab
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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
Gemcitabine and Rituximab
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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. |
- Progression Free Survival (PFS) [ Time Frame: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks) ]PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)
- Overall Survival [ Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks) ]Overall survival is from randomization to death due to any cause
- Complete Response Rate [ Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks) ]CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy. CR is defined as the disappearance of all target lesions.
- Overall Response Rate [ Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks) ]ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
- Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug [ Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks) ]The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)
- Individual Concentration-time Profiles of Patients Will be Compared to Existing Data Using Simulations (Visual Predictive Checks) [ Time Frame: within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion ]To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov
- To Generate Individual Secondary PK Parameters (eg, Exposure, Half-life Etc.) Using Descriptive Statistics [ Time Frame: within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion ]To characterize the PK profile of pixantrone when co-administered with rituximab. Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient. The goal is to enroll approx. 20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni. Hospital Kralovske Vinohrady, Uni. Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV. IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni. Hospital Martin, National Onclogy Inst., Uni. Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni. Hospital J.A. Reiman Presov

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321541

Study Director: | Simran B Singh, MS, GWCP | Sr. Director, Clinical Operations |
Documents provided by CTI BioPharma:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | CTI BioPharma |
ClinicalTrials.gov Identifier: | NCT01321541 |
Other Study ID Numbers: |
PIX306 (PIX-R Trial) |
First Posted: | March 23, 2011 Key Record Dates |
Results First Posted: | November 19, 2021 |
Last Update Posted: | November 19, 2021 |
Last Verified: | September 2021 |
non-hodgkin lymphoma Diffuse large B-cell lymphoma Pixantrone non hodgkin's lymphoma DLBCL transformed from Indolent Lymphoma Follicular Grade 3 Lymphoma DLBCL |
relapsed aggressive NHL Rituximab Rituxan NHL de novo DLBCL |
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Pixantrone Aggression Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Behavioral Symptoms Gemcitabine |
Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors |