Clinical trial · Interventional
Study of Lonafarnib and Gleevec in Chronic Myelogenous Leukemia
Phase I Study of Lonafarnib (SCH66336) and Gleevec (Imatinib Mesylate) in Chronic Myelogenous Leukemia (CML)
NCT00047502CI-TRIAL-00035674completedPhase 1ClinicalTrials.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 this study if to investigate the effect of lonafarnib (SCH66336) in combination with Gleevec in the treatment of CML.
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 Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imatinib Mesylate (Gleevec) | Drug | Imatinib | ALIAS |
| Lonafarnib (SCH66336) | Drug | Lonafarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gleevec + SCH 66336
- description
- Participants in CHRONIC PHASE receive Gleevec 400 mg by mouth every day, and SCH66336 100 mg by mouth twice a day. Participants in ACCELERATED OR BLASTIC PHASE receive Gleevec 600 mg by mouth every day, and SCH66336 100 mg by mouth twice a day.
- interventionNames
- Drug: Lonafarnib (SCH66336)
- Drug: Imatinib Mesylate (Gleevec)
Primary outcomes (1)
- measure
- Dose Limiting Toxicity (DLT)
- timeFrame
- 3 months
- description
- Dose-Limiting Toxicity (DLT) defined as grade 3 or 4 non-hematologic toxicity (NCI common criteria, version 2.0). Grade 3 or 4 nausea and vomiting considered DLT only if uncontrolled by antiemetics. Grade 3 or 4 diarrhea considered DLT only if uncontrolled for 48 hours despite adequate antidiarrheal therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
1. Patients with Philadelphia chromosome (ph) positive CML in any of the following categories:
1. Chronic phase patients must have failed therapy with Gleevec. Failure will be defined as: (i) Patients who have not achieved or have lost their hematologic response at 3 months from the start of therapy with Gleevec, or (ii) Patients who have not achieved or have lost their cytogenetic response after 6 months of therapy with Gleevec, or (iii) Patients who have not achieved or have lost their major cytogenetic response after 12 months of therapy with Gleevec.
2. Patients in accelerated phase, defined as the presence of any of the following features: (i) blasts in peripheral blood (PB) or bone marrow (BM) \>/= 15% (but \< 30%), (ii) blasts + promyelocytes in PB or BM \>/= 30%, (iii) basophils in PB or BM \>/= 20%, (iv) platelets \< 100 x 10e9/L unrelated to therapy, (v) clonal evolution.
3. Patients in blast phase, defined by the presence of \>/= 30% blasts in peripheral blood and/or bone marrow, or the presence of extramedullary disease.
2\) Patients in accelerated or blastic phase are eligible whether they have received and/or failed Gleevec or not.
3\) Age \>/= 16 years.
4\) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping eith the policies of the hospital. The only acceptable consent form is attached at the end of the protocol.
5\) Performance status \</= 2 by Zubrod scale.
6\) Patients must have adequate hepatic functions (bilirubin \</= 2.0 mg/dl) and renal functions (creatinine \</= 2 mg/dl).
7\) Exclusion criteria:
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1. Patients with QTc \> 500 msec.
2. Patients with severe heart disease (cardiac class III and IV) will be excluded.References
Publications (0)
Data not yet available
No reference posted for this study.