Clinical trial · Interventional
Cilengitide in Treating Patients With Acute Myeloid Leukemia
A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
NCT00089388CI-TRIAL-00009084terminatedPhase 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)
This randomized phase II trial is studying how well cilengitide works in treating patients with acute myeloid leukemia. Cilengitide may stop the growth of cancer cells by blocking the enzymes necessary for their growth
Conditions
Conditions (12)
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 Without Maturation (M1) | Adult Acute Myeloid Leukemia without Maturation | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia in Remission |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cilengitide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (low dose cilengitide)
- description
- Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
- interventionNames
- Drug: cilengitide
- type
- EXPERIMENTAL
- label
- Arm II (higher dose cilengitide)
- description
- Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
- interventionNames
- Drug: cilengitide
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria:
* Diagnosis of acute myeloid leukemia (AML)
* In first complete remission after at least 1 course of induction chemotherapy AND 1-2 courses of consolidation chemotherapy for newly diagnosed AML, as defined by the following:
* No evidence of disease in bone marrow
* Recovery of peripheral blood counts
* Platelet count \> 100,000/mm\^3
* Absolute neutrophil count \> 1,500/mm\^3
* Must be able to start study medication within 60 days from the start of the last consolidation therapy
* Must not have a suitable donor, refused, or ineligible for hematopoietic stem call transplantation
* None of the following AML subtypes or chromosomal translocations:
* Acute promyelocytic leukemia
* t(8;21)
* t(16;16)
* inv(16)
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* See Disease Characteristics
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Creatinine clearance \> 60mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No prior investigational agents specifically designated as an antiangiogenic agent
* No concurrent prophylactic hematopoietic colony-stimulating factors
* See Disease Characteristics
* Recovered from prior consolidation chemotherapy
* No other concurrent anticancer therapies
* No other concurrent investigational cytotoxic agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.