Clinical trial · Interventional
Idarubicin and Cytarabine With or Without Bevacizumab in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Randomized Phase II Trial of Idarubicin + Ara-C +/- Bevacizumab in Patients Age < 60 With Untreated Acute Myeloid Leukemia
NCT00096148CI-TRIAL-00009107terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively complete.
Summary
Brief summary (as posted)
Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Bevacizumab may stop the growth of cancer by stopping blood flow to the leukemic cells in the bone marrow. Giving idarubicin and cytarabine with bevacizumab may kill more cancer cells. It is not yet know whether giving idarubicin together with cytarabine is more effective with or without bevacizumab in treating acute myeloid leukemia. This randomized phase II trial is studying how well giving idarubicin and cytarabine together with bevacizumab works compared to idarubicin and cytarabine alone in treating patients with newly diagnosed acute myeloid leukemia
Conditions
Conditions (24)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Basophilic Leukemia | Adult Acute Basophilic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Acute Eosinophilic Leukemia | — | UNRESOLVED | — |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| idarubicin | Drug | Idarubicin | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (idarubicin, cytarabine)
- description
- Arm I: Patients receive idarubicin IV over 1 hour on days 1-3 and cytarabine IV continuously over 24 hours on days 1-4. Post-CR therapy: All patients receive 4 post-CR chemotherapy courses approximately every 28 days in the absence of disease progression or unacceptable toxicity. Course 1: Patients receive cytarabine IV continuously over 24 hours on days 1-5. Course 2 and 4: Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-4.
- interventionNames
- Drug: idarubicin
- Drug: cytarabine
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (idarubicin, cytarabine, bevacizumab)
- description
- Patients receive idarubicin and cytarabine as in arm I. Patients also receive bevacizumab\* IV over 30-90 minutes on day 1. Patients who do not achieve complete remission (CR) after the first induction course may receive a second induction course approximately 28 days\* later. Patients who do not achieve CR after 2 courses are removed from the study. NOTE: \*Patients in arm II receive bevacizumab, independently of chemotherapy administration schedule, once every 21 days for 1 year from CR date. Post-CR therapy: All patients receive 4 post-CR chemotherapy courses approximately every 28 days in the absence of disease progression or unacceptable toxicity. Course 1: Patients receive cytarabine IV continuously over 24 hours on days 1-5. Course 2 and 4: Patients receive idarubicin IV over 1 hour and cytarabine IV continuously over 24 hours on days 1-4.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 59 Years
Show eligibility criteria text
Inclusion Criteria:
* Newly diagnosed acute myeloid leukemia (AML)
* No acute promyelocytic leukemia
* None of the following cytogenetic abnormalities\*:
* t(8;21)
* t(16;16)
* inv(16)
* No history or clinical evidence of primary brain tumors or brain metastasis
* Performance status - ECOG 0-2
* No bleeding diathesis or coagulopathy (unless related to AML)
* Bilirubin ≤ 2.0 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* Creatinine ≤ 2.0 times ULN
* No proteinuria
* No more than 1 g of protein on 24-hour urine collection
* LVEF ≥ 50%
* No uncontrolled hypertension
* No New York Heart Association class II-IV congestive heart failure
* No serious cardiac arrhythmia requiring medication
* No peripheral vascular disease ≥ grade II
* No stroke within the past 6 months
* No arterial thromboembolic event within the past 6 months, including any of the following:
* Transient ischemic attack
* Cerebrovascular accident
* Myocardial infarction
* Unstable angina
* No other clinically significant cardiovascular disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3-4 months after study participation
* No serious or non-healing wound ulcer or bone fracture
* No uncontrolled infection
* No significant traumatic injury within the past 28 days
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No history or clinical evidence of CNS disease (e.g., seizures not controlled with standard medical therapy)
* Prior or concurrent transfusions or hematopoietic growth factors for AML allowed
* No concurrent prophylactic hematopoietic colony-stimulating factors
* Prior or concurrent hydroxyurea for AML allowed
* More than 28 days since prior major surgery or open biopsy
* No concurrent major surgery
* No other prior therapy for AML
* No concurrent full-dose anticoagulation therapy
* Concurrent prophylactic anticoagulation (e.g. low-dose warfarin to maintain patency of permanent indwelling IV catheters) allowed provided INR \< 1.5
* No other concurrent anticancer therapies
* No other concurrent investigational cytotoxic agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.