Treatment of Acute Leukemia Relapse After Allotransplantation

Treatment of Relapsed Acute Leukemia After Allogeneic Stem Cell Transplantation: Disease Stabilization Through Chemotherapy, Immunomodulatory Treatment and Immunotherapy

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01369368

Enrollment

Registered

2011-06-08

Start date

2013-08-31

Completion date

2020-10-31

Last updated

2015-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia, Allogeneic stem cell transplantation, Relapse, Disease stabilization, survival

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.

Interventions

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

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Disease stabilization	5 years	Strict criteria defined in the protocol.

Secondary

Measure	Time frame
Survival	5 years

Countries

Norway

Contacts

Primary ContactOystein Bruserud, MD

oystein.bruserud@haukeland.no0047 55975000

Backup ContactBjorn Tore Gjertsen, MD

bjorn.gjertsen@med.uib.no0047 55972997

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026