NCT02480608

Brief Summary

The study will test the tolerability and efficacy of the combination therapy Imatinib/Hydroxyurea (HU) in patients with chronic myeloid leukemia (CML) in first chronic phase (CP1) newly diagnosted or failing interferon-based therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_1

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

7.3 years

First QC Date

June 10, 2015

Last Update Submit

June 23, 2015

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Outcome Measures

Primary Outcomes (1)

  • number of participants with complete molecular response as a measure of efficacy

    complete molecular response is achieved if BCR-ABL (breakpoint cluster region-Abelson murine leukemia) transcripts became undetectable

    18 months

Study Arms (2)

combination Imatinib + Hydroxyurea

EXPERIMENTAL

Patients who meet the inclusion criteria will be started on 400 mg Imatinib daily. In part 1 of the protocol, the dose of HU will be increased by 500 mg at 3-weekly intervals until the maximal tolerated dose has been reached. In part 2 of the study, patients will be randomized to receive either the combination or Imatinib monotherapy.

Drug: ImatinibDrug: Hydroxyurea

monotherapy Imatinib

ACTIVE COMPARATOR

Imatinib monotherapy

Drug: Imatinib

Interventions

ImatinibDRUG
combination Imatinib + Hydroxyureamonotherapy Imatinib
HydroxyureaDRUG
combination Imatinib + Hydroxyurea

Eligibility Criteria

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

You may qualify if:

  • Ph-positive CML in CP1, newly diagnosed or resistant (hematologic or cytogenetic) or intolerant to interferon-based therapy
  • Age ≥ 18 years
  • Negative pregnancy test
  • Low- and intermediate risk patients younger than 45 with an HLA (Human Leukocyte Antigen) -matched sibling donor and medically fit to undergo allografting should be included only after they have been adequately counselled about the potential risk (of disease progression) associated with delaying the allograft
  • Informed consent

You may not qualify if:

  • Objective signs of disease progression beyond CP1 defined as
  • bone marrow or peripheral blood blasts \> 15% and/or
  • blasts + promyelocytes ≥ 30% and/or
  • peripheral blood basophils ≥ 20% and/or
  • platelets \< 100/nl and/or
  • chromosomal abnormalities in addition to the Ph chromosome
  • Findings suggestive of extramedullary involvement
  • Any severe and uncontrolled medical condition
  • Previous treatment with Imatinib (only part 2 of the study)
  • History of non-compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lange T, Niederwieser C, Gil A, Krahl R, von Grunhagen U, Al-Ali HK, Jentsch-Ullrich K, Spohn C, Lakner V, Assmann M, Junghanss C, Cross M, Hehlmann R, Deininger M, Pfirrmann M, Niederwieser D. No advantage of Imatinib in combination with hydroxyurea over Imatinib monotherapy: a study of the East German Study Group (OSHO) and the German CML study group. Leuk Lymphoma. 2020 Dec;61(12):2821-2830. doi: 10.1080/10428194.2020.1786556. Epub 2020 Jul 16.

    PMID: 32672489DERIVED

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib MesylateHydroxyurea

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesUrea

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Thoralf Lange

Study Record Dates

First Submitted

June 10, 2015

First Posted

June 24, 2015

Study Start

April 1, 2004

Primary Completion

August 1, 2011

Study Completion

May 1, 2013

Last Updated

June 24, 2015

Record last verified: 2015-06