Myeloid LeukemiaPhase 1NCT00126893
Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
A Phase 1 study testing CC-401 in people with Myeloid Leukemia, run by Celgene Corporation at 1 site in United States.
Trial summary
This is a single center Phase 1 study to evaluate the safety, pharmacokinetics and pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloid Leukemia
- What is being tested?
- CC-401
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Sep 2006
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must understand and voluntarily sign an informed consent form.
- Must be greater than or equal to 18 years of age at the time of signing the informed consent form.
- Must have a diagnosis of high-risk myeloid leukemia, defined as:
- Subjects > 70 years of age with newly diagnosed acute myelogenous leukemia (AML) (regardless of karyotype) who decline conventional induction chemotherapy;
- Subjects > 60 years of age with newly diagnosed AML and poor-risk cytogenetics or a history of secondary AML who decline conventional induction chemotherapy;
- Subjects with newly diagnosed AML who do not experience a CR after at least 2 cycles of induction chemotherapy;
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- Subjects with AML who do not experience a second or greater complete remission after 1 but no more than 2 cycles of re-induction chemotherapy;
- Subjects with recurrence of AML after a remission duration of less than three months in subjects < 60 years of age or remission duration of less than six months in subjects > 60 years of age; or
- Subjects with imatinib-refractory chronic myeloid leukemia (CML) in blast crisis defined as > 30% blasts and promyelocytes in the peripheral blood or bone marrow smear despite treatment with imatinib > 600 mg/daily
- ECOG performance status < 2 (see Appendix 2).
- Serum creatinine < 2 mg/d and ALT (SGPT), alkaline phosphatase, and conjugated bilirubin < 2 times the upper limit of normal.
- No conventional or investigational anti-leukemic treatment within two weeks of the administration of study drug with the exception of hydroxyurea to control the peripheral blood blast count.
- Subjects must have recovered from any prior treatment-related toxicities.
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
- Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study medication and 4 weeks after the last dose of study medication
Who cannot join
- Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging; individuals with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks prior to enrollment in the study.
- Subjects who are pregnant or lactating; women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days prior to the initial treatment with CC-401.
- Subjects with severe or life threatening active, unresolved systemic infections.
- Prior history of malignancy other than myeloid leukemia (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.
- Known HIV-1 positivity.
- Known hepatitis B surface antigen (HBsAg) positivity.
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- Prior treatment with CC-401
- Use of any other experimental drug or treatment within 28 days of baseline
- Inability to provide a bone marrow aspirate
- Subjects with severe or life-threatening active bleeding refractory to platelet transfusion
- Subjects with severe or life-threatening anemia refractory to red blood cell transfusion
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center
Indianapolis, Indiana, 46202-5149
About this study
Official title: Phase 1 Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
This is a single center Phase 1 study to evaluate the safety, pharmacokinetics and pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia.
- Conditions
- Myeloid Leukemia
- Being tested
- CC-401
- Keywords
- Leukemia, AML, CC401, CC-401, Celgene, High Risk Myeloid Leukemia, Myeloid Leukemia
- Medical subject headings
- Leukemia, Myeloid, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-401Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startOct 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloid LeukemiaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126893
- Sponsor's protocol ID
- CC-401-AML-001
- Status last verified
- Dec 2006
- First submitted
- 3 Aug 2005
- Last updated
- 15 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Determine the Optimal Biologic Dose of CC-401 in Subjects With High-Risk Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT00126893
- Acronym / sponsor ID
- CC-401-AML-001
- Conditions
- Myeloid Leukemia
- Keywords
- Leukemia, AML, CC401, CC-401, Celgene, High Risk Myeloid Leukemia, Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Sep 2006 (actual)
- First posted
- 5 Aug 2005 (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 is a single center Phase 1 study to evaluate the safety, pharmacokinetics and pharmacodynamics of CC-401 in subjects with refractory acute myelogenous leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must understand and voluntarily sign an informed consent form.
- Must be greater than or equal to 18 years of age at the time of signing the informed consent form.
- Must have a diagnosis of high-risk myeloid leukemia, defined as:
- ECOG performance status < 2 (see Appendix 2).
- Serum creatinine < 2 mg/d and ALT (SGPT), alkaline phosphatase, and conjugated bilirubin < 2 times the upper limit of normal.
Key exclusion criteria (12 listed)
- Subjects with central nervous system (CNS) involvement as documented by spinal fluid cytology or imaging; individuals with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks prior to enrollment in the study.
- Subjects who are pregnant or lactating; women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days prior to the initial treatment with CC-401.
- Subjects with severe or life threatening active, unresolved systemic infections.
- Prior history of malignancy other than myeloid leukemia (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.
- Known HIV-1 positivity.
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 |
|---|---|---|
| CC-401 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-401 in people with Myeloid Leukemia, run by Celgene Corporation 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 16 inclusion and 12 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 15 May 2007. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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. 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.
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 15 May 2007.