N/A
N=158
Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
Diffuse Large B-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01369784 ↗Enrolled (actual)
158
Serious AEs
12.3%
Results posted
Apr 2016
Primary outcome: Primary: R-IPI Index (Revised International Prognostic Index) — 3.4; 32.2; 64.4 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY R-IPI Index (Revised International Prognostic Index) |
9.6; 47.3; 43.2 | — |
| PRIMARY R-IPI Index (Revised International Prognostic Index) |
9.6; 47.3; 43.2 | — |
| PRIMARY Predictive Value of R-IPI at Diagnosis |
4; 1; 28; 19; 56; 37 | 0.812 |
| SECONDARY Bcl-2 Expression |
30; 5; 111 | — |
| SECONDARY Bcl-2 Expression |
30; 5; 111 | — |
| SECONDARY Bcl-6 Expression |
14.4; 7.5; 78.1 | — |
| SECONDARY Bcl-6 Expression |
14.4; 7.5; 78.1 | — |
| SECONDARY p-53 Expression |
12.3; 10.3; 77.4 | — |
| SECONDARY p53 Expression |
5.5; 4.8; 89.7 | — |
| SECONDARY Multiple Myeloma Oncogene 1 (MUM-1) Expression |
16.4; 10.3; 73.3 | — |
| SECONDARY MUM-1 Expression |
5.5; 5.5; 89.0 | — |
| SECONDARY Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status |
56; 54; 22; 12; 2 | — |
| SECONDARY Ann Arbor Staging |
12.3; 21.9; 19.9; 45.9 | — |
| SECONDARY Response to First Line of Treatment |
58; 5; 52; 10; 21 | — |
| SECONDARY Response to Second Line of Treatment |
46; 15; 27; 9; 38; 10 | — |
| SECONDARY Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis |
50; 8; 28; 5; 30; 24 | 0.612 |
| SECONDARY Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis |
34; 14; 40; 28; 6; 23 | 0.402 |
| SECONDARY Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis |
13; 8; 5; 6; 67; 46 | 0.557 |
| SECONDARY Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis |
17; 6; 7; 8; 65; 42 | 0.234 |
Summary
The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.
Eligibility Criteria
- Age 18 > years old
- Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab
- Ability to understand and willingness to sign a written informed consent
Data sourced from ClinicalTrials.gov (NCT01369784). 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.