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Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

NCT01794702 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2019-05-30

Study results available
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Summary

The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia.

The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied.

Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die.

Clofarabine is designed to interfere with the growth and development of cancer cells.

Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.

Conditions

Interventions

DRUG

Decitabine

Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)

DRUG

Idarubicin

Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)

DRUG

Cytarabine

Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)

DRUG

Clofarabine

Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9) Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nitin Jain, MBBS · M.D. Anderson Cancer Center

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-20
Primary Completion
2018-01-11
Completion
2018-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01794702 on ClinicalTrials.gov