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Treatment of Acute Leukemia Relapse After Allotransplantation

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AML relapse within one year after transplantation
  • Blood and marrow sampling being possible
  • Expected survival at least 4 weeks
  • No expected drug interactions
  • Informed consent possible

Exclusion Criteria:

  • Intolerance to any study drug
  • Serious kidney or liver disease
  • Informed consent not possible
  • Previous pancreatitis

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions

Outcomes

Primary Outcome Measures

Disease stabilization
Strict criteria defined in the protocol.

Secondary Outcome Measures

Survival

Full Information

First Posted
June 7, 2011
Last Updated
June 23, 2015
Sponsor
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT01369368
Brief Title
Treatment of Acute Leukemia Relapse After Allotransplantation
Official Title
Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with relapse of acute leukemia often only receive supportive therapy. Our hypothesis is that a combination therapy can stabilize the disease for patients with early relapse after allogeneic stem cell transplantation. The investigators will combine 5-azacitidine 100 mg daily subcutaneously (days 1-3), valproic acid (continuous therapy from day 1), All-trans retinoic acid (days 1-14) and hydroxurea (continuous treatment from day 15 of first cycle. Azacitidine and ATRA can be repeated with 5 weeks intervals, donor leukocyte infusions on day 10 is allowed from the second cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Azacitidine, valproic acid, all-trans retinoic acid, hydroxyurea, eventually donor leukocyte infusions
Intervention Type
Drug
Intervention Name(s)
Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.
Other Intervention Name(s)
Give as repeated cycles with 5 weeks intervals. Donor leukocyte infusions are allowed from cycle 2.
Intervention Description
Azacitidine 100 mg day 1-3 in each cycle Valproic acid, continuous therapy from day 1 All-trans retinoic acid 22.5 mg/m2 twice daily day 1-14 in each cycle Hydroxurea 500 mg initially eventually increased to 1 g daily. Eventually donor leukocyte infusions on day 10 from the second cycle.
Primary Outcome Measure Information:
Title
Disease stabilization
Description
Strict criteria defined in the protocol.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AML relapse within one year after transplantation Blood and marrow sampling being possible Expected survival at least 4 weeks No expected drug interactions Informed consent possible Exclusion Criteria: Intolerance to any study drug Serious kidney or liver disease Informed consent not possible Previous pancreatitis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oystein Bruserud, MD
Phone
0047 55975000
Email
oystein.bruserud@haukeland.no
First Name & Middle Initial & Last Name or Official Title & Degree
Bjorn Tore Gjertsen, MD
Phone
0047 55972997
Email
bjorn.gjertsen@med.uib.no
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
N-5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oystein Bruserud, MD

12. IPD Sharing Statement

Learn more about this trial

Treatment of Acute Leukemia Relapse After Allotransplantation

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