Adult Acute Basophilic LeukemiaPhase 2NCT00089388
Cilengitide in Treating Patients With Acute Myeloid Leukemia
A Phase 2 study testing cilengitide in people with Adult Acute Basophilic Leukemia and Adult Acute Eosinophilic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7)
- What is being tested?
- cilengitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 35Show fewer
- 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 agents
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
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
Read the detailed description
PRIMARY OBJECTIVES:
- Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.
SECONDARY OBJECTIVES:
- Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity.
- Conditions
- Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Being tested
- cilengitide
- Medical subject headings
- Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Megakaryoblastic, Acute, Leukemia, Monocytic, Acute, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Erythroblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilengitideDrug
Also called EMD 121974
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (low dose cilengitide) | Experimental | Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks. Receives: Drug: cilengitide |
| Arm II (higher dose cilengitide) | Experimental | Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks. Receives: Drug: cilengitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.
Measured: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Secondary outcomes (2)
Overall survival
Analyzed using Kaplan-Meier life table methods and Cox proportional hazard regression modeling.
Measured: Up to 2 years
Toxicity of cilengitide graded using the CTC version 3
Compared between the two treatment arms using Fisher's exact test
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionJun 2006
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Acute Basophilic LeukemiaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Srdan Verstovsek, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089388
- Sponsor's protocol ID
- NCI-2012-02621
- Other IDs
- MDA-2003-1007, CDR0000378310
- Status last verified
- Jan 2013
- First submitted
- 4 Aug 2004
- Last updated
- 24 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of EMD 121974 as Maintenance Therapy for Patinets With Acute Myeloid Leukemia in Complete Remission
- ClinicalTrials.gov ID
- NCT00089388
- Acronym / sponsor ID
- NCI-2012-02621
- Conditions
- Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 2004
- Primary completion
- Jun 2006 (actual)
- First posted
- 5 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- Determine 10-month relapse-free survival of patients with acute myeloid leukemia in first complete remission treated with cilengitide as maintenance therapy.
SECONDARY OBJECTIVES:
- Determine overall survival of patients treated with this drug. II. Determine the safety and toxicity of this drug in these patients. III. Determine the biological activity of this drug in cells from these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks.
Arm II: Patients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks.
In both arms, courses repeat every 4 weeks in the absence of disease relapse or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (low dose cilengitide) | Experimental | Drug: cilengitidePatients receive cilengitide IV at a lower dose over 1 hour twice weekly for 4 weeks. |
| Arm II (higher dose cilengitide) | Experimental | Drug: cilengitidePatients receive cilengitide IV at a higher dose over 1 hour twice weekly for 4 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- 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:
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cilengitideAlso: EMD 121974Given IV | Drug | Arm I (low dose cilengitide), Arm II (higher dose cilengitide) |
Primary outcome
Disease-free survival (DFS)
Time frame: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years
Kaplan-Meier curves will be constructed for each treatment group. Median DFS in each group and corresponding 95% confidence intervals will be estimated. The two treatment groups will be compared using log-rank test.
2 secondary outcomes
Overall survival
Time frame: Up to 2 years
Toxicity of cilengitide graded using the CTC version 3
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srdan Verstovsek principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cilengitide in people with Adult Acute Basophilic Leukemia and Adult Acute Eosinophilic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: From initiation of induction chemotherapy until the first incidence of disease or death due to any cause, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.