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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryComplete 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)
SecondaryProgression-Free Survival (PFS)18 months after 6 cycles of treatment; approximately 24 monthsThe time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause.
SecondaryOverall Survival18 months after 6 cycles of treatment; approximately 24 monthsThe time between the date of randomization and the date of death due to any cause.
SecondaryOverall Response Rate (ORR) Lasting at Least 4 Monthsapproximately 24 monthsThe 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.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYComplete Response (CR) and Complete Response Unconfirmed (CRu)EOT; approximately 6 monthsIntent to Treat (all randomized patients)percentage of randomized patientsNUMBER
SECONDARYProgression-Free Survival (PFS)18 months after 6 cycles of treatment; approximately 24 monthsIntent-to-treat patientsmonthsMEDIAN
SECONDARYOverall Survival18 months after 6 cycles of treatment; approximately 24 monthsIntent-To-Treat (ITT) Population.MonthsMEDIAN
SECONDARYOverall Response Rate (ORR) Lasting at Least 4 Monthsapproximately 24 monthsIntent-To-Treat (ITT) populationparticipantsNUMBER

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Complete Response (CR) and Complete Response Unconfirmed (CRu)Experimental GroupEND OF TREATMENT: CR/CRu, n (%)20.095% Confidence Interval 11.4 to 31.3percentage of randomized patients
Complete Response (CR) and Complete Response Unconfirmed (CRu)Comparator GroupEND OF TREATMENT: CR/CRu, n (%)5.795% Confidence Interval 1.6 to 14.0percentage of randomized patients
Complete Response (CR) and Complete Response Unconfirmed (CRu)Experimental GroupEND OF STUDY: CR/CRu, n (%)24.395% Confidence Interval 14.8 to 36.0percentage of randomized patients
Complete Response (CR) and Complete Response Unconfirmed (CRu)Comparator GroupEND OF STUDY: CR/CRu, n (%)7.195% Confidence Interval 2.4 to 15.9percentage of randomized patients
Progression-Free Survival (PFS)Experimental Group5.395% Confidence Interval 2.3 to 6.2months
Progression-Free Survival (PFS)Comparator Group2.695% Confidence Interval 1.9 to 3.5months
Overall SurvivalExperimental Group10.295% Confidence Interval 6.4 to 15.7Months
Overall SurvivalComparator Group7.695% Confidence Interval 5.4 to 9.3Months
Overall Response Rate (ORR) Lasting at Least 4 MonthsExperimental Group12participants
Overall Response Rate (ORR) Lasting at Least 4 MonthsComparator Group6participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDExperimental Group70
Overall StudySTARTEDComparator Group70
Overall StudyCOMPLETEDExperimental Group20
Overall StudyCOMPLETEDComparator Group16
Overall StudyNOT COMPLETEDExperimental Group50
Overall StudyNOT COMPLETEDComparator Group54

Adverse events262

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnemiaBlood and lymphatic system disordersExperimental Group2168
otherAnemiaBlood and lymphatic system disordersComparator Group2267
otherNeutropeniaBlood and lymphatic system disordersExperimental Group3468
otherNeutropeniaBlood and lymphatic system disordersComparator Group1667
otherLeukopeniaBlood and lymphatic system disordersExperimental Group1768
otherLeukopeniaBlood and lymphatic system disordersComparator Group767
otherThrombocytopeniaBlood and lymphatic system disordersExperimental Group1468
otherThrombocytopeniaBlood and lymphatic system disordersComparator Group1367
otherFebrile NeutropeniaBlood and lymphatic system disordersExperimental Group668
otherFebrile NeutropeniaBlood and lymphatic system disordersComparator Group267

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityExperimental Group4968
Total, all-cause mortalityComparator Group5267
Total, other adverse eventsExperimental Group6668
Total, other adverse eventsComparator Group6167
Total, serious adverse eventsExperimental Group3568
Total, serious adverse eventsComparator Group3067

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
22652183DERIVED

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.

ComparisonSource
Experimental Group vs Comparator Group: Overall Response Rate (ORR) Lasting at Least 4 MonthsTrial comparisons
Experimental Group vs Comparator Group: deaths from any causeTrial comparisons
Experimental Group vs Comparator Group: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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