CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Dinaciclib +3 moredrug
Likely dose
Not stated in 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/NCT01515176
NCT01515176Phase 2Completed

Phase 1b/2 Study of Dinaciclib (SCH 727965) and Ofatumumab in Relapsed and Refractory CLL/SLL/B-PLL

National Cancer Institute (NCI)·interventional·Posted Jan 23, 2012·Updated Mar 15, 2018

In Brief

A Phase 2 clinical trial evaluating Dinaciclib, Laboratory Biomarker Analysis, and 2 other interventions for Chronic Lymphocytic Leukemia and 3 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and the best dose of ofatumumab and dinaciclib and to see how well they work in treating patients with relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, or B-cell prolymphocytic leukemia. Monoclonal antibodies, such as ofatumumab, can find cancer cells and help kill them. Dinaciclib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with dinaciclib may kill more cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 23, 2012
Enrollment StartJan 1, 2012
Primary CompletionMar 4, 2015
Study CompletionJul 19, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.4 years ago

Interventions

Dinaciclibdrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Ofatumumabbiological

Given IV

Pharmacological Studyother

Correlative studies