CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
arsenic trioxide +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/NCT00551460
NCT00551460Phase 2Completed

S0535, A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

SWOG Cancer Research Network·interventional·Posted Oct 31, 2007·Updated Jan 10, 2023

In Brief

A Phase 2 clinical trial evaluating arsenic trioxide, gemtuzumab ozogamicin, and 3 other interventions for Leukemia. Completed, enrolled 78 participants across 192 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination chemotherapy may be more effective in treating promyelocytic leukemia. PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination chemotherapy works in treating patients with previously untreated promyelocytic leukemia.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2007
Enrollment StartNov 15, 2007
Primary CompletionJun 1, 2017
Study CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 18.7 years ago

Interventions

arsenic trioxidedrug

gemtuzumab ozogamicindrug

mercaptopurinedrug

methotrexatedrug

tretinoindrug