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 |
Show 58 Study LocationsSponsors 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 Diffuse large B-cell lymphoma non hodgkin's lymphoma DLBCL transformed from Indolent Lymphoma Follicular Grade 3 Lymphoma DLBCL relapsed |
aggressive NHL Rituximab Rituxan Pixantrone NHL de novo DLBCL |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Aggression 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 19, 2013