Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 3:39 AM
Study NCT ID:
NCT00175812
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Differentiation Induction in Acute Myelogenous Leukemia
Sponsor:
University of Bergen
Organization:
Study Overview
Official Title:
Differentiation Induction Therapy for Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Patients to be included:
1. Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
2. 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.
1. Elderly patients above 60 years of age with newly diagnosed acute myelogenous leukemia (AML) who cannot receive conventional intensive chemotherapy.
2. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: