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Leukemia SPORE Phase II DAC Study for R/R and Elderly Acute AML and MDS

NCT02190695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-05-19

No results posted yet for this study

Summary

The purpose of this study is to find a new way to treat Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Chronic Myelomonocytic Leukemia (CMML). All the drugs are used to treat AML and MDS but are not usually combined together. The investigators are looking at both the safety and Efficacy of each combination.

Conditions

Interventions

DRUG

Decitabine

20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.

DRUG

Carboplatin

AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.

DRUG

Arsenic trioxide

0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Patricia Kropf, MD · Temple University Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2018-06-26
Completion
2020-04-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02190695 on ClinicalTrials.gov