Phase 3
N=312
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
Diffuse Large B-cell Lymphoma · de Novo DLBCL · DLBCL Transformed From Indolent Lymphoma · Follicular Grade 3 Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01321541 ↗Enrolled (actual)
312
Serious AEs
38.4%
Results posted
Nov 2021
Primary outcome: Primary: Progression Free Survival (PFS) — 7.3; 6.3 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pixantrone + Rituximab (Drug); Gemcitabine + Rituximab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CTI BioPharma
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) |
7.3; 6.3 | — |
| SECONDARY Overall Survival |
13.3; 19.6 | — |
| SECONDARY Complete Response Rate |
55; 34 | — |
| SECONDARY Overall Response Rate |
61.9; 43.9 | — |
| SECONDARY Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug |
140; 140 | — |
Summary
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.
Eligibility 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT01321541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.