Clinical trial · Interventional
Treatment of CML Patients With Imatinib and Hydroxyurea (CML2004)
Treatment of CML Patients With Imatinib and Hydroxyurea
NCT02480608CI-TRIAL-00018358CML2004completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Myelogenous, Chronic, BCR-ABL Positive | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydroxyurea | Drug | Hydroxyurea | ALIAS |
| Imatinib | Drug | Imatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- combination Imatinib + Hydroxyurea
- description
- 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.
- interventionNames
- Drug: Imatinib
- Drug: Hydroxyurea
- type
- ACTIVE_COMPARATOR
- label
- monotherapy Imatinib
- description
- Imatinib monotherapy
- interventionNames
- Drug: Imatinib
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ph-positive CML in CP1, newly diagnosed or resistant (hematologic or cytogenetic) or intolerant to interferon-based therapy 2. Age ≥ 18 years 3. Negative pregnancy test 4. 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 5. Informed consent Exclusion Criteria: 1. 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 2. Findings suggestive of extramedullary involvement 3. Any severe and uncontrolled medical condition 4. Previous treatment with Imatinib (only part 2 of the study) 5. History of non-compliance 6. Simultaneous inclusion in other studies Important note: previous treatment with Imatinib only is not an exclusion criterion for part 1 of the study.
References
Publications (1)
- DERIVEDLange 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 32672489