MedTrace Logo

Differentiation Induction in Acute Myelogenous Leukemia

NCT00175812 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-06-24

No results posted yet for this study

Summary

Hypothesis: Differentiation induction therapy in acute myelogenous leukemia (AML) can be used to achieve disease control and stabilize peripheral blood counts in patients with acute myelogenous leukemia.

Adult patients (\<18 years of age) who can be included: Elderly patients (\>60 years of age) with newly diagnosed AML who cannot achieve standard chemotherapy, patients with relapsed or resistant AML. Patients with relapsed or resistant AML who cannot receive intensive chemotherapy.

Treatment: Patients will be treated with all-trans retinoic acid (oral administration), valproic acid (7 days intravenous administration and later oral administration)and theophyllamine (7 days intravenous administration and later oral administration). Duration of treatment at least 2 months or until disease progression. Maximal duration of treatment 2 years.

Followup: Clinical evaluation, peripheral blood samples, bone marrow samples.

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

all-trans retinoic acid (ATRA)

All-trans retinoic acid 22.5 mg/square meter twice daily days 1-14

DRUG

Valproic acid

Valproic acid, highest dose without side effects from day 3 until progression

DRUG

Theophyllin

Theophyllin, targetted serum level 50-100 from day 3 until progression

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Oystein Bruserud, MD · University of Bergen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-05-31
Completion
2009-11-30

Countries

  • Norway

Study Locations

More Related Trials

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 NCT00175812 on ClinicalTrials.gov