Clinical trial · Interventional
High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)
Randomized Trial of Therapy of Early Phase Chronic Myelogenous Leukemia With High-Dose Imatinib Mesylate (Gleevec) Alone or in Combination With Peg-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF)
NCT00050531CI-TRIAL-00022103completedPhase 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)
The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.
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, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec | Drug | — | UNRESOLVED |
| Peg-alpha interferon (Peg-Intron) | Drug | — | UNRESOLVED |
| Sargramostim (GM-CSF) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gleevec
- description
- Gleevec 400 mg orally twice daily.
- interventionNames
- Drug: Gleevec
- Drug: Peg-alpha interferon (Peg-Intron)
- type
- EXPERIMENTAL
- label
- Gleevec + Peg-Intron + GM-CSF
- description
- Gleevec 400 mg orally twice daily. Peg-Intron 0.5 mcg/kg each week subcutaneously. GM-CSF 125 mcg/m\^2 three times per week subcutaneously.
- interventionNames
- Drug: Gleevec
- Drug: Peg-alpha interferon (Peg-Intron)
- Drug: Sargramostim (GM-CSF)
Primary outcomes (2)
- measure
- Duration of Pathological Complete Response Negativity or Cytogenetic Response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Ph-positive CML in early chronic phase CML who have received no or minimal prior therapy, (\<1 month of prior IFN-alpha (with or without ara-C) and/or Gleevec). 2. Eastern Cooperative Oncology Group (ECOG) performance of 0-2. 3. Adequate end organ function, defined as the following: total bilirubin \< 1.5 x upper limit of normal (ULN), serum glutamate pyruvate transaminase (SGPT) \< 2.5 x ULN, creatinine \< 1.5 x ULN 4. Signed informed consent. Exclusion Criteria: 1. New York Heart Association (NYHA) cardiac class 3-4 heart disease. 2. Psychiatric disability (psychosis) 3. Pregnant or lactating females 4. Late chronic phase, accelerated or blastic phase
References
Publications (3)
- DERIVEDJain P, Kantarjian H, Boddu PC, Nogueras-Gonzalez GM, Verstovsek S, Garcia-Manero G, Borthakur G, Sasaki K, Kadia TM, Sam P, Ahaneku H, O'Brien S, Estrov Z, Ravandi F, Jabbour E, Cortes JE. Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs. Blood Adv. 2019 Mar 26;3(6):851-861. doi: 10.1182/bloodadvances.2018025874. PMID 30885996
- DERIVEDIssa GC, Kantarjian HM, Gonzalez GN, Borthakur G, Tang G, Wierda W, Sasaki K, Short NJ, Ravandi F, Kadia T, Patel K, Luthra R, Ferrajoli A, Garcia-Manero G, Rios MB, Dellasala S, Jabbour E, Cortes JE. Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment. Blood. 2017 Nov 9;130(19):2084-2091. doi: 10.1182/blood-2017-07-792143. Epub 2017 Aug 23. PMID 28835440
- DERIVEDJain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25. PMID 23620574