Differentiation Induction in Acute Myelogenous Leukemia

Sponsor

University of Bergen (Other)

Overall Status

Completed

CT.gov ID

NCT00175812

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myelogenous Leukemia	Drug: all-trans retinoic acid (ATRA) Drug: Valproic acid Drug: Theophyllin	Phase 1/Phase 2

Detailed Description

Patients to be included:

Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
Adult patients of any age (> 18 years of age)with relapsed or resistant AML who cannot receive conventional intensive chemotherapy or allogeneic stem cell transplantation.

We plan to include at least 20 patients, but if possible 30 patients during a 3 years period. The first patient was included November 2004.

Treatment:

All-trans retinoic acid (ATRA) administered orally 22.5 mg/m2 twice daily for 14 days, repeated every third month.

Valproic acid started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Theophyllamine started on day 3 of ATRA therapy, the first week as intravenous administration and later oral administration.

Duration of treatment at least 2 months unless side effects,until disease progression or an overall duration of treatment of 2 years.

Supportive therapy according to the hospitals general guidelines.

Followup:

The first week treatment in hospital. Later out-patient treatment with regular controls including clinical examination, peripheral blood parameters (including serum valproic acid and theophyllamin levels), bone marrow samples.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Differentiation Induction Therapy for Acute Myelogenous Leukemia

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATRA plus valproic acid plus theophyllin ATRA for 14 days, continuous treatment with valproic acid and theophyllin	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

Arm

Intervention/Treatment

Experimental: ATRA plus valproic acid plus theophyllin

ATRA for 14 days, continuous treatment with valproic acid and theophyllin

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