Clinical trial · Interventional
Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
Phase I Study Of Flavopiridol In Combination With Imatinib Mesylate (STI571, Gleevec) In Bcr/Abl+ Hematological Malignancies
- 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: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with flavopiridol may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol and imatinib mesylate in treating patients with hematologic cancer.
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 |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Chronic or accelerated phase chronic myelogenous leukemia (CML) with 1 of the following:
* Hematologic progression during prior imatinib mesylate treatment
* Less than a complete hematologic response after at least 3 months of prior imatinib mesylate treatment
* Less than a major cytogenetic response after at least 6 months of imatinib mesylate treatment (cytogenetic response documented by karyotype or fluorescence in situ hybridization \[FISH\])
* Blastic phase CML\*
* Acute lymphoblastic leukemia\*
* Acute myeloid leukemia\* NOTE: \*Patients may be enrolled at presentation, in remission, or upon relapse
* Bcr/Abl+ in bone marrow confirmed by karyotype or FISH
* No known CNS malignancy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN (5 times ULN if hepatic involvement suspected \[stratum 2 only\])
Renal
* Creatinine no greater than 2 times ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents
* No other concurrent uncontrolled medical illness
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-2 during the first course of study therapy unless clinically indicated for management of febrile neutropenia or thrombocytopenia
* Concurrent epoetin alfa allowed if started before study entry and it remains clinically appropriate
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* See Disease Characteristics
* Recovered from all prior therapy
* No other concurrent investigational or anticancer agents
* No concurrent combination antiretroviral therapy for HIV-positive patientsReferences
Publications (0)
Data not yet available