Clinical trial · Interventional
STI571 ProspectIve RandomIzed Trial: SPIRIT
A Phase III Prospective Randomized Comparison of Imatinib at a Dose of 400mg in Combination With Peg-Interferon-alpha2a (Peg-IFNa2a) or Cytarabine (Ara-C)Versus Imatinib at a Dose of 600mg Versus Imatinib a Dose of 400mg for Previously Untreated Chronic Myelogenous Leukemia (CML) in Chronic Phase
- 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)
To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase. To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.
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 |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Imatinib mesylate 400 mg
- interventionNames
- Drug: Imatinib mesylate 400 mg
- Drug: Imatinib mesylate 600 mg
- Drug: Imatinib 400 mg + Peg-Interferon
- Drug: Imatinib mesylate 400 mg + Cytarabine
- type
- EXPERIMENTAL
- label
- Imatinib mesylate 600 mg
- interventionNames
- Drug: Imatinib mesylate 400 mg
- Drug: Imatinib mesylate 600 mg
- Drug: Imatinib 400 mg + Peg-Interferon
- Drug: Imatinib mesylate 400 mg + Cytarabine
- type
- EXPERIMENTAL
- label
- Imatinib mesylate 400 mg +Peg interferon
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age * Patients with Bcr-Abl positive CML in chronic phase. * Patients within 14 weeks of diagnosis and previously untreated for CML except for hydroxyurea and/or anagrelide. * No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly * ECOG performance score of 0-2 * acceptable hepatic, renal, and cardiac function * Informed consent signed up Exclusion Criteria: * Depressive syndrome not controlled * Uncontrolled medical illnesses. * Women with childbearing potential and male patients who are unwilling or unable to use an adequate method to avoid pregancy for the entire period of the study
References
Publications (4)
- DERIVEDBruzzoni-Giovanelli H, Gonzalez JR, Sigaux F, Villoutreix BO, Cayuela JM, Guilhot J, Preudhomme C, Guilhot F, Poyet JL, Rousselot P. Genetic polymorphisms associated with increased risk of developing chronic myelogenous leukemia. Oncotarget. 2015 Nov 3;6(34):36269-77. doi: 10.18632/oncotarget.5915. PMID 26474455
- DERIVEDDelord M, Rousselot P, Cayuela JM, Sigaux F, Guilhot J, Preudhomme C, Guilhot F, Loiseau P, Raffoux E, Geromin D, Genin E, Calvo F, Bruzzoni-Giovanelli H. High imatinib dose overcomes insufficient response associated with ABCG2 haplotype in chronic myelogenous leukemia patients. Oncotarget. 2013 Oct;4(10):1582-91. doi: 10.18632/oncotarget.1050. PMID 24123600
- DERIVEDJohnson-Ansah H, Guilhot J, Rousselot P, Rea D, Legros L, Rigal-Huguet F, Nicolini FE, Mahon FX, Preudhomme C, Guilhot F. Tolerability and efficacy of pegylated interferon-alpha-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer. 2013 Dec 15;119(24):4284-9. doi: 10.1002/cncr.28328. Epub 2013 Sep 16. PMID 24105694
- DERIVEDPreudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F, Coiteux V, Gardembas M, Berthou C, Vekhoff A, Rea D, Jourdan E, Allard C, Delmer A, Rousselot P, Legros L, Berger M, Corm S, Etienne G, Roche-Lestienne C, Eclache V, Mahon FX, Guilhot F; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med. 2010 Dec 23;363(26):2511-21. doi: 10.1056/NEJMoa1004095. PMID 21175313