Clinical trial · Interventional
Study of Molecular and Genetic Abnormalities in Patients With Myeloid Neoplasms
Evaluation of the Incidence and Prognostic Impact of Molecular and Genetic Abnormalities in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome and Myeloproliferative Neoplasms
NCT02084563CI-TRIAL-00024741completedPhase 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 objective of this study is to describe the prevalence and prognostic impact of the most common genetic abnormalities in patients with Myeloid Neoplasms, including Acute Myeloid Leukemia (AML), Myeloproliferative Neoplasms (MPN), Myelodysplastic Syndromes (MDS) and Myeloproliferative/Myelodysplastic Neoplasms. Patients will have samples of blood and/or bone marrow collected and sent to Hospital Israelita Albert Einstein for analysis and storage. Patients with a diagnosis of Acute Myeloid Leukemia will be treated according to an uniform protocol.
Conditions
Conditions (4)
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 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative/Myelodysplastic Neoplasm | — | UNRESOLVED | — |
| Myeloproliferative Neoplasms | Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Stem Cell Transplantation | Drug | — | UNRESOLVED |
| Autologous Stem Cell Transplantation | Drug | — | UNRESOLVED |
| Consolidation Chemotherapy | Drug | — | UNRESOLVED |
| Decitabine | Drug | Decitabine | ALIAS |
| Induction Chemotherapy | Drug | — | UNRESOLVED |
| Low Dose Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- AML-Intensive Chemotherapy
- description
- Patients with Acute Myeloid Leukemia fit for intensive chemotherapy Patients will receive Induction Chemotherapy, and CR will be evaluated after 28 days. Patients who achieve CR post-induction chemotherapy will receive post-remission therapy according to risk: * Low risk patients: Consolidation chemotherapy or Autologous stem cell transplantation * Intermediate and high-risk patients: Allogeneic stem cell transplantation Patients who do not achieve CR may receive one second induction cycle, and if CR is achieved may proceed to post-remission therapy as per above. Patients who do not achieve CR after two cycles of induction will be deemed refractory and removed from the study.
- interventionNames
- Drug: Induction Chemotherapy
- Drug: Consolidation Chemotherapy
- Drug: Autologous Stem Cell Transplantation
- Drug: Allogeneic Stem Cell Transplantation
- type
- OTHER
- label
- AML-Non-intensive chemotherapy
- description
- Patients with acute myeloid leukemia not fit for intensive chemotherapy Patients will receive induction chemotherapy with either low dose cytarabine or decitabine. Assignment to each drug will depend on drug availability and physician discretion. No randomization will be done between the drugs. Cycles will be repeated every 28 days. Patients who achieve CR will continue to post-consolidation therapy with either cytarabine or decitabine, based on the induction therapy received. Patients will receive a maximum of 4 cycles until achieving CR, if no response is seen after 4 cycles patients will be deemed refractory.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Acute Myeloid Leukemia-Intensive Chemotherapy Inclusion Criteria: * Diagnosis of AML according to WHO criteria * Age greater than 18 years * Performance status (ECOG) between 0-2 * Adequate liver and kidney function * Signed Informed Consent form * No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts * Adequate contraception for fertile men and women * Eligible for intensive chemotherapy (as judged by the treating physician) Exclusion Criteria: * Acute myeloid leukemia with retinoic acid receptor alpha (RARA) translocations (APL, acute promyelocytic leukemia) * Pregnant women * HIV-positivity * New York Heart Association class III and IV congestive heart failure * Patient refuses to use adequate contraception * History of hypersensibility to any of the used chemotherapy drugs * Patient refuses to sign informed consent form Acute Myeloid Leukemia-Non-Intensive Chemotherapy Inclusion Criteria: * Diagnosis of AML according to WHO criteria * Age greater than 18 years * Signed Informed Consent form * No prior therapy for AML, except use of hydroxyurea for control of elevated white blood cell counts * Adequate contraception for fertile men and women * Non-eligible for intensive chemotherapy (as judged by the treating physician) Exclusion Criteria: * Acute myeloid leukemia with RARA translocations (APL, acute promyelocytic leukemia) * Pregnant women * HIV-positivity * Patient refuses to use adequate contraception * History of hypersensibility to any of the used chemotherapy drugs * Patient refuses to sign informed consent form Chronic Myeloid Disorders: Inclusion Criteria: * Diagnosis of Myeloproliferative Neoplasm or Myelodysplastic Syndrome or Myeloproliferative/Myelodysplastic Neoplasm according to WHO criteria * Age greater than 18 years * Signed Informed Consent form Exclusion Criteria: * Patient refuses to sign informed consent form
References
Publications (0)
Data not yet available
No reference posted for this study.