Clinical trial · Interventional
Evaluation of "Dose-dense Therapy" by S-HAM in Comparison to Conventionally Timed Double Induction in Patients With Acute Myeloid Leukemia (AML)
A Randomized, Risk and Age Adapted Comparison of the Dose-Dense Regimen S-HAM (Sequential High Dose Cytosine Arabinoside and Mitoxantrone) Versus Standard Double Induction for Initial Chemotherapy of Adult Patients With Acute Myeloid Leukemia
NCT01382147CI-TRIAL-00030686AMLCG 2008completedPhase 3ClinicalTrials.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)
Evaluation weather early chemotherapy attempts for remission induction can improve the results of patients with Acute Myeloid Leukemia (AML), as compared to the standard group.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C, Mitoxantrone, Daunorubicin, Thioguanin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S-HAM
- description
- S-HAM (S-HAMescalated for younger patients and S-HAMbasis for elderly patients)
- interventionNames
- Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
- type
- ACTIVE_COMPARATOR
- label
- TAD-HAM (younger) or HAM-HAM (elderly)
- description
- is TAD-9 - HAM for younger patients (with 2 mandatory induction cycles) and HAM (- HAM) for the elderly patients with the second HAM cycle only applied in the case of inadequate blast clearance (\> 5%) in the day 16 bone marrow aspirate
- interventionNames
- Drug: Ara-C, Mitoxantrone, Daunorubicin, Thioguanin
Primary outcomes (1)
- measure
- Overall response rate, aiming at a 15% increase in the CR/PR rate by S-HAM induction versus conventional double induction [TAD - HAM for younger patients, HAM (- HAM) for elderly patients].
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly diagnosed AML (except acute promyelocytic leukemia) according to the WHO classification including patients with secondary AML and AML after preceding hematologic disorders * Age 18 years or older * Informed consent. Before any study specific procedure including randomisation is done or before study medication is administered, the subject, or legally acceptable representative, must have given written informed consent for participation in the study. Exclusion Criteria: * Acute promyelocytic leukemia (APL) * Previous or concurrent malignancies other than AML * Previous treatment with colony-stimulating factors, interleukins or interferons * Known hypersensitivity to Escherichia coli derived products (e.g. Filgrastim, HUMULIN® Insulin, L-Asparaginase, HUMATROPE® Growth Hormone, INTRON A®) * Antibody-based or cell-based immunotherapies * Respiratory insufficiency with pO2 \<60 mmHg * Heart failure NYHA III° or IV° * Elevated creatinine \>2.0 mg/dl * Elevated bilirubin \>2.0 mg/dl * Pregnancy or lactation * Females without adequate contraception * Known HIV and/or hepatitis C infection * Severe neurologic or psychiatric disease * Psychiatric, addictive, or any disorder, which compromises ability to give truly informed consent for participation in this study * Concerns for subject's compliance with the protocol procedures * Lack of willingness to record and circulate personal disease-related informations defined in the study protocol
References
Publications (7)
- DERIVEDCusan M, Larkin K, Nicolet D, Jurinovic V, Mrozek K, Batcha AMN, Rothenberg-Thurley M, Schneider S, Sauerland C, Gorlich D, Krug U, Berdel WE, Woermann BJ, Hiddemann W, Braess J, Spiekermann K, Greif PA, Blachly JS, Mims AS, Walker CJ, Walker MC, Oakes CC, Orwick S, Carroll AJ, Blum WG, Powell BL, Kolitz JE, Moore JO, Mayer RJ, Larson RA, Stone RM, Byrd JC, Metzeler KH, Herold T, Eisfeld AK. Multi-dimensional analysis of adult acute myeloid leukemia cross-continents reveals age-associated trends in mutational landscape and treatment outcomes (Acute Myeloid Leukemia Cooperative Group & Alliance for Clinical Trials in Oncology). Leukemia. 2025 Dec;39(12):2926-2934. doi: 10.1038/s41375-025-02644-0. Epub 2025 Sep 19. PMID 40973764
- DERIVEDArcher KJ, Fu H, Mrozek K, Nicolet D, Mims AS, Uy GL, Stock W, Byrd JC, Hiddemann W, Braess J, Spiekermann K, Metzeler KH, Herold T, Eisfeld AK. Identifying long-term survivors and those at higher or lower risk of relapse among patients with cytogenetically normal acute myeloid leukemia using a high-dimensional mixture cure model. J Hematol Oncol. 2024 May 3;17(1):28. doi: 10.1186/s13045-024-01553-6. PMID 38702786
- DERIVEDPastore F, Gittinger H, Raab S, Tschuri S, Ksienzyk B, Konstandin NP, Schneider S, Rothenberg-Thurley M, Horny HP, Werner M, Sauerland MC, Amler S, Gorlich D, Berdel WE, Wormann B, Braess J, Hiddemann W, Tischer J, Herold T, Metzeler KH, Spiekermann K. Acute megakaryoblastic leukaemia shows high frequency of chromosome 1q aberrations and dismal outcome. Br J Haematol. 2023 Sep;202(6):1165-1177. doi: 10.1111/bjh.18982. Epub 2023 Jul 16. PMID 37455345
- DERIVEDKunadt D, Stasik S, Metzeler KH, Rollig C, Schliemann C, Greif PA, Spiekermann K, Rothenberg-Thurley M, Krug U, Braess J, Kramer A, Hochhaus A, Scholl S, Hilgendorf I, Brummendorf TH, Jost E, Steffen B, Bug G, Einsele H, Gorlich D, Sauerland C, Schafer-Eckart K, Krause SW, Hanel M, Hanoun M, Kaufmann M, Wormann B, Kramer M, Sockel K, Egger-Heidrich K, Herold T, Ehninger G, Burchert A, Platzbecker U, Berdel WE, Muller-Tidow C, Hiddemann W, Serve H, Stelljes M, Baldus CD, Neubauer A, Schetelig J, Thiede C, Bornhauser M, Middeke JM, Stolzel F; A. M. L. Cooperative Group (AMLCG), Study Alliance Leukemia (SAL). Impact of IDH1 and IDH2 mutational subgroups in AML patients after allogeneic stem cell transplantation. J Hematol Oncol. 2022 Sep 5;15(1):126. doi: 10.1186/s13045-022-01339-8.