At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 33 enrolled

Drug / intervention

Bendamustine + Rituximab + Pixantrone +1 moredrug

Likely dose

Bendamustine + Rituximab + Pixantrone 55mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01491841

NCT01491841Phase 1Completed

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Phase I/II Study of the Combination of Bendamustine, Rituximab and Pixantrone in Patients With Relapsed/Refractory B Cell Non-Hodgkin's Lymphoma

Anne Beaven, MD·interventional·Posted Dec 14, 2011·Updated Mar 4, 2020

In Brief

A Phase 1 clinical trial evaluating Bendamustine + Rituximab + Pixantrone and Pegfilgrastim for Non-Hodgkin's Lymphoma. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This is a phase I trial of the combination of bendamustine, rituximab and pixantrone in patients with relapsed/refractory B cell non-Hodgkin lymphoma. A standard 3+3 design will be used to determine the maximum tolerated dose (MTD) of the combination. A static dose of bendamustine and rituximab will be used and the dose of pixantrone will be escalated in each cohort. Pixantrone will be dosed on a 21 day cycle at 55mg/m2, 85mg/m2, and 115mg/m2 in sequential cohorts dependent on acceptable toxicity profile at each dose level. MTD will be determined based on DLTs that occur during the first 2 cycles of the drug combination. Phase II did not proceed as planned due to withdrawal of pixantrone from the US.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsNon-Hodgkin's Lymphoma

CountriesUnited States

CollaboratorsCTI BioPharma

Timeline

Phase 1CompletedFinished

201220132014201520162017201820192020202120222023202420252026

Enrollment StartNov 2011

First PostedDec 2011

Primary CompletionNov 2016

Study CompletionFeb 2017

TodayJul 2026

First PostedDec 14, 2011

Enrollment StartNov 1, 2011

Primary CompletionNov 22, 2016

Study CompletionFeb 17, 2017

TodayJul 2, 2026

Enrollment to primary: 5.1 yearsPosted 14.5 years ago

Interventions

Bendamustine + Rituximab + Pixantronedrug

Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).

Pegfilgrastimdrug

6mg administered on Day 2 of each 21 day cycle