Trial · NCT00088530
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
NCT00088530, Phase 3, Completed, CTI BioPharma; results first posted 2017-06-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL). Trials, record NCT00088530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00088530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
- NCT number
- NCT00088530
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 140 participants, actual
- Lead sponsor
- CTI BioPharma
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- pixantrone, cyclophosphamide, vincristine, rituximab, prednisone, Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
- First posted
- 2004-07-29
- Last updated
- 2020-02-05
- Results first posted
- 2017-06-01
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) and Complete Response Unconfirmed (CRu) | EOT; approximately 6 months | Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) |
| Secondary | Progression-Free Survival (PFS) | 18 months after 6 cycles of treatment; approximately 24 months | The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. |
| Secondary | Overall Survival | 18 months after 6 cycles of treatment; approximately 24 months | The time between the date of randomization and the date of death due to any cause. |
| Secondary | Overall Response Rate (ORR) Lasting at Least 4 Months | approximately 24 months | The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) and Complete Response Unconfirmed (CRu) | EOT; approximately 6 months | Intent to Treat (all randomized patients) | percentage of randomized patients | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | 18 months after 6 cycles of treatment; approximately 24 months | Intent-to-treat patients | months | MEDIAN |
| SECONDARY | Overall Survival | 18 months after 6 cycles of treatment; approximately 24 months | Intent-To-Treat (ITT) Population. | Months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) Lasting at Least 4 Months | approximately 24 months | Intent-To-Treat (ITT) population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) and Complete Response Unconfirmed (CRu) | Experimental Group | END OF TREATMENT: CR/CRu, n (%) | 20.0 | 95% Confidence Interval 11.4 to 31.3 | percentage of randomized patients |
| Complete Response (CR) and Complete Response Unconfirmed (CRu) | Comparator Group | END OF TREATMENT: CR/CRu, n (%) | 5.7 | 95% Confidence Interval 1.6 to 14.0 | percentage of randomized patients |
| Complete Response (CR) and Complete Response Unconfirmed (CRu) | Experimental Group | END OF STUDY: CR/CRu, n (%) | 24.3 | 95% Confidence Interval 14.8 to 36.0 | percentage of randomized patients |
| Complete Response (CR) and Complete Response Unconfirmed (CRu) | Comparator Group | END OF STUDY: CR/CRu, n (%) | 7.1 | 95% Confidence Interval 2.4 to 15.9 | percentage of randomized patients |
| Progression-Free Survival (PFS) | Experimental Group | 5.3 | 95% Confidence Interval 2.3 to 6.2 | months | |
| Progression-Free Survival (PFS) | Comparator Group | 2.6 | 95% Confidence Interval 1.9 to 3.5 | months | |
| Overall Survival | Experimental Group | 10.2 | 95% Confidence Interval 6.4 to 15.7 | Months | |
| Overall Survival | Comparator Group | 7.6 | 95% Confidence Interval 5.4 to 9.3 | Months | |
| Overall Response Rate (ORR) Lasting at Least 4 Months | Experimental Group | 12 | participants | ||
| Overall Response Rate (ORR) Lasting at Least 4 Months | Comparator Group | 6 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Group | 70 | |
| Overall Study | STARTED | Comparator Group | 70 | |
| Overall Study | COMPLETED | Experimental Group | 20 | |
| Overall Study | COMPLETED | Comparator Group | 16 | |
| Overall Study | NOT COMPLETED | Experimental Group | 50 | |
| Overall Study | NOT COMPLETED | Comparator Group | 54 |
Source ClinicalTrials.gov
Adverse events262
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Experimental Group | 21 | 68 | |
| other | Anemia | Blood and lymphatic system disorders | Comparator Group | 22 | 67 | |
| other | Neutropenia | Blood and lymphatic system disorders | Experimental Group | 34 | 68 | |
| other | Neutropenia | Blood and lymphatic system disorders | Comparator Group | 16 | 67 | |
| other | Leukopenia | Blood and lymphatic system disorders | Experimental Group | 17 | 68 | |
| other | Leukopenia | Blood and lymphatic system disorders | Comparator Group | 7 | 67 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Experimental Group | 14 | 68 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Comparator Group | 13 | 67 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Experimental Group | 6 | 68 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Comparator Group | 2 | 67 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Group | 49 | 68 |
| Total, all-cause mortality | Comparator Group | 52 | 67 |
| Total, other adverse events | Experimental Group | 66 | 68 |
| Total, other adverse events | Comparator Group | 61 | 67 |
| Total, serious adverse events | Experimental Group | 35 | 68 |
| Total, serious adverse events | Comparator Group | 30 | 67 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22652183 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Group vs Comparator Group: Overall Response Rate (ORR) Lasting at Least 4 Months | Trial comparisons |
| Experimental Group vs Comparator Group: deaths from any cause | Trial comparisons |
| Experimental Group vs Comparator Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00088530
GET https://conductscience.org/api/trials/v1/NCT00088530/events?page=2