CI

At a glance

ClinicalIndex Comparison Record
Phase 2Terminated· 6 enrolled
Drug / intervention
Blinatumomab +11 morebiological
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/NCT03518112
NCT03518112Phase 2Terminated
Terminated

Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL)

M.D. Anderson Cancer Center·interventional·Posted May 8, 2018·Updated Nov 4, 2022

In Brief

A Phase 2 clinical trial evaluating Blinatumomab, Cyclophosphamide, and 10 other interventions for Philadelphia Chromosome Negative and 2 related conditions. Terminated early, enrolled 6 participants across 1 site.

Signals

Trial was terminated early

Detailed Summary

This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.

Study Details

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

Timeline

Phase 2TerminatedFinished
20192020202120222023202420252026
First PostedMay 8, 2018
Enrollment StartApr 18, 2018
Primary CompletionMay 27, 2021
TodayJul 1, 2026
Enrollment to primary: 3.1 yearsPosted 8.1 years ago

Interventions

Blinatumomabbiological

Given IV

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT or IV

Dexamethasonedrug

PO or IV

Filgrastimbiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV

Mercaptopurinedrug

Given PO

Methotrexatedrug

Given IT or IV

Pegfilgrastimbiological

Given SC

Rituximabbiological

Given IV

Vincristine Sulfatedrug

Given IV