Clinical trial · Interventional
CLAG Gleevec in Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase II Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Relapsed or Refractory Acute Myeloid Leukemia
NCT00955916CI-TRIAL-00014963completedPhase 2Results postedClinicalTrials.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 purpose of the study is to find out what effects (good and bad) Gleevec® (Imatinib mesylate) combined with chemotherapy has on participants and their acute myeloid leukemia.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CLAG Regimen | Drug | — | UNRESOLVED |
| Gleevec® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CLAG Regimen with Gleevec®
- description
- Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).
- interventionNames
- Drug: CLAG Regimen
- Drug: Gleevec®
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 8 weeks per participant
- description
- Overall Response Rate: Morphologic Complete Remission (CR) + Morphologic Complete Remission with incomplete blood count recovery (CRi) for evaluable participants. CR - Bone Marrow: \< 5% blasts without Auer rods with at least 20% cellularity with maturation of all cell lines, No presence of unique phenotype by flow cytometry identical to what was found in the pretreatment specimen, No persistent dysplasia; Peripheral: normal blood counts, absolute neutrophil count (ANC) \> 1.0 k/μl and platelets \> 100 k/μl ANC \> 1.0 k/μl and platelets \> 100 k/μl (Peripheral blood counts documenting recovery can be utilized within 4 weeks of the bone marrow); No evidence of extramedullary leukemia. CRi - All CR criteria are met except for residual Neutropenia \<1.0 x 10\^9/L platelets \< 100 k/μl.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men and Women of all ethnic groups whose age is ≥ 18 years old. * Diagnosis of AML or CML blast crisis, according to World Health Organization (WHO) criteria, except acute promyelocytic leukemia AML-M3 French-American-British (FAB) subgroup. A documentation of relapse is required by a bone marrow/aspirate within 4 weeks of registration. * Refractory or Relapsed AML. Refractory AML is defined as failure to achieve CR after 2 cycles of induction chemotherapy or persistent (\>40%) bone marrow blasts after one cycle of chemotherapy induction. * Relapsed AML is defined as any evidence of disease recurrence after achieving complete response (CR) (more than 5% myeloblasts). Early relapse is defined as that occurring within 12 months and late relapse is defines as that occurring after 12 months. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must sign a written informed consent. * Females of childbearing potential (FOCP) must not be pregnant or actively nursing a child. They must have a negative pregnancy test 7 days before initiation of study drug administration * Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. * Male and females of reproductive potential must agree to employ an effective barrier method of birth control throughout the duration of the trial and for 3 months following study medication discontinuation. * Prior allogeneic or autologous stem cell transplantation is allowed. Exclusion Criteria: * Abnormal Kidney Functions: creatinine ≥2.5 mg/dL. * Abnormal Liver Functions: Bilirubin more 3 mg/dL, transaminases (AST/ALT) more than 2.5 times the institutional upper limits of normal (IULN). * Systemic active infection, unless controlled on active therapy. * Patients with Grade III/IV cardiac problems as defined by the New York Heart Association (NYHA) Criteria ( i.e., congestive heart failure, myocardial infarction within 6 months of the study), or ejection fraction (EF)\< 30%. * Patient has known chronic liver disease (i.e., chronic active hepatitis, hepatitis B, hepatitis C, and cirrhosis). * Patient has known diagnosis of human immunodeficiency virus (HIV) infection. * History of other malignancy, except non-melanotic skin cancers or no disease recurrence/progression for more than 2 years. * Patients that have received investigational agents within 1 month of study entry. * History of allergic reaction attributed to compounds of similar chemical or biologic composition to Gleevec or any component of the CLAG regimen * Prior therapy with CLAG chemotherapy regimen * Any adverse event attributable to previous chemotherapy regimen must be resolved to grade 1 or less at time of registration.
References
Publications (0)
Data not yet available
No reference posted for this study.