Clinical trial · Interventional
Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia
Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.
- 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.
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 | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (15)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| asparaginase | Drug | Asparaginase | ALIAS |
| autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| mercaptopurine | Drug | Mercaptopurine |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of Participants Reaching Disease Free Survival
- timeFrame
- At 60 months
Secondary outcomes (2)
- measure
- Number of Patients Reaching Complete Hematological Response After Induction Therapy
- timeFrame
- At the end of induction, day +50
- measure
- Percentage of Participants Reaching Overall Survival
- timeFrame
- At 60 months
- description
- Overall survival from diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria: * Negative myeloperoxidase stain * Phenotype T (T-ALL) or B (B-ALL) * No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative) PATIENT CHARACTERISTICS: * Creatinine ≤ 2.5 mg/dL (after adequate hydration) * SGOT and SGPT ≤ 3 times upper limit of normal * LVEF ≥ 50% * No severe psychiatric disorders * No other concurrent malignant disease * No presence of documented infections not responding to antibiotic and/or antifungal therapy * Not pregnant PRIOR CONCURRENT THERAPY: * No prior steroids * No prior antiblastic chemotherapy * No other concurrent chemotherapy or radiotherapy
References
Publications (3)
- BACKGROUNDChiaretti S, Vitale A, Vignetti M, Piciocchi A, Fazi P, Elia L, Falini B, Ronco F, Ferrara F, De Fabritiis P, Luppi M, La Nasa G, Tedeschi A, Califano C, Fanin R, Dore F, Mandelli F, Meloni G, Foa R. A sequential approach with imatinib, chemotherapy and transplant for adult Ph+ acute lymphoblastic leukemia: final results of the GIMEMA LAL 0904 study. Haematologica. 2016 Dec;101(12):1544-1552. doi: 10.3324/haematol.2016.144535. Epub 2016 Aug 11. PMID 27515250
- RESULTMessina M, Chiaretti S, Iacobucci I, Tavolaro S, Lonetti A, Santangelo S, Elia L, Papayannidis C, Paoloni F, Vitale A, Guarini A, Martinelli G, Foa R. AICDA expression in BCR/ABL1-positive acute lymphoblastic leukaemia is associated with a peculiar gene expression profile. Br J Haematol. 2011 Mar;152(6):727-32. doi: 10.1111/j.1365-2141.2010.08449.x. Epub 2011 Jan 31. PMID 21623761
- DERIVEDPiciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996. Am J Hematol. 2021 Sep 1;96(9):E334-E338. doi: 10.1002/ajh.26253. Epub 2021 Jun 9. No abstract available. PMID 34048072