NCT01369368

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

4.2 years

First QC Date

June 7, 2011

Last Update Submit

June 23, 2015

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemiaAllogeneic stem cell transplantationRelapseDisease stabilization, survival

Outcome Measures

Primary Outcomes (1)

  • Disease stabilization

    Strict criteria defined in the protocol.

    5 years

Secondary Outcomes (1)

  • Survival

    5 years

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.

Interventions

Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.DRUG

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.

Also known as: Give as repeated cycles with 5 weeks intervals. Donor leukocyte infusions are allowed from cycle 2.
1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, N-5021, Norway

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrence

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Central Study Contacts

Oystein Bruserud, MD

CONTACT

0047 55975000oystein.bruserud@haukeland.no

Bjorn Tore Gjertsen, MD

CONTACT

0047 55972997bjorn.gjertsen@med.uib.no

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2011

First Posted

June 8, 2011

Study Start

August 1, 2013

Primary Completion

October 1, 2017

Study Completion

October 1, 2020

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

NO(1)