Clinical trial · Interventional
STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic Leukemia
A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia
- 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: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Chronic myelogenous leukemia in lymphoid blast crisis
* Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction
* No more than 1 prior course of induction chemotherapy
* Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization
* At least 30% blasts in bone marrow
* Ineligible for or refused allogeneic stem cell transplantation
* Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin less than 3 times upper limit of normal (ULN)
* ALT and AST less than 3 times ULN
Renal:
* Creatinine less than 2 times ULN
Cardiovascular:
* No New York Heart Association class III or IV cardiac disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior allogeneic bone marrow or peripheral blood stem cell transplantation
* At least 48 hours since prior interferon alfa
Chemotherapy:
* See Disease Characteristics
* At least 24 hours since prior hydroxyurea
* At least 6 weeks since prior busulfan
* Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No prior therapy for blast crisis except hydroxyurea
* No prior salvage or reinduction therapy for Ph+ ALL
* At least 4 weeks since other prior investigational agentsReferences
Publications (0)
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