Clinical trial · Interventional
Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.
Conditions
Conditions (2)
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathological confirmation of one of the following: * Untreated refractory anemia with excess blasts (RAEB) in transformation * RAEB with greater than 10% blasts cells in the bone marrow * Other myelodysplastic syndromes * Profound cytopenias * Acute myelogenous leukemia (AML) supervening after overt myelodysplastic syndromes (MDS) of more than 6 months duration * No blast crisis of chronic myeloid leukemia * No leukemias supervening after other myeloproliferative disease * No leukemias supervening after overt MDS of less than 6 months duration * The following are allowed: * Secondary acute leukemias following Hodgkin's disease or other malignancies * Secondary leukemias following exposure to alkylating agents or radiation PATIENT CHARACTERISTICS: Age: * 16-60 Performance status: * WHO 0-2 Hematopoietic: * If RAEB, blasts cells of greater than 10% in bone marrow * Neutrophil count less than 5,000 or Platelet count less than 200,000 * Chronic myelomonocytic leukemia (CMML) with greater than 5% blasts cells in bone marrow, or CMML with neutrophil count greater than 160,000 or monocyte count greater than 2,600 Hepatic: * Bilirubin no greater than 1.5 times normal Renal: * Creatinine no greater than 1.5 times normal Cardiovascular: * No patients with severe heart failure requiring diuretics or an ejection fraction of less than 50% Neurological: * No severe concomitant neurological disease PRIOR CONCURRENT THERAPY: Biologic therapy: * No treatments within the past 4 weeks of: * Biological response modifiers AND/OR * Low dose Ara-C Chemotherapy: * No prior intensive treatment for MDS or AML Endocrine therapy: * Not specified Radiotherapy: * No prior treatment for MDS or AML Surgery: * Not specified
References
Publications (1)
- RESULTde Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellstrom-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21. PMID 20494931