CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
cyclophosphamide +4 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/NCT01925131
NCT01925131Phase 1Completed

S1312, A Phase I Study of Inotuzumab Ozogamicin (NSC-772518) in Combination With CVP (Cyclophosphamide, Vincristine, Prednisone) for Patients With Relapsed/Refractory CD22-Positive Acute Leukemia (Including B-ALL, Mixed Phenotypic Leukemia, and Burkitt's Leukemia)

SWOG Cancer Research Network·interventional·Posted Aug 19, 2013·Updated May 3, 2023

In Brief

A Phase 1 clinical trial evaluating cyclophosphamide, vincristine sulfate, and 3 other interventions for Acute Leukemias of Ambiguous Lineage and 4 related conditions. Completed, enrolled 50 participants across 5 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of inotuzumab ozogamicin when given together with combination chemotherapy in treating patients with relapsed or refractory acute leukemia. Immunotoxins, such as inotuzumab ozogamicin, can find cancer cells that express cluster of differentiation (CD)22 and kill them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving inotuzumab ozogamicin together with combination chemotherapy may kill more cancer cells.

Study Details

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 19, 2013
Enrollment StartJun 13, 2014
Primary CompletionJan 1, 2022
Study CompletionJan 1, 2023
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 12.9 years ago

Interventions

cyclophosphamidedrug

Given IV

vincristine sulfatedrug

Given IV

prednisonedrug

Given PO

inotuzumab ozogamicinbiological

Given IV

laboratory biomarker analysisother

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