Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175812
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2005-09-09
Brief Title:
Differentiation Induction in Acute Myelogenous Leukemia
Sponsor:
University of Bergen
Organization:
University of Bergen
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 administrationand 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 administrationand 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 agewith 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 225 mgm2 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 effectsuntil 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 agewith 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 225 mgm2 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 effectsuntil 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:
None
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?:
None