Non-Hodgkin's LymphomaPhase 1/2NCT00109356
Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
A Phase 1/2 study testing AQ4N (Chemotherapy) in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Novacea at 1 site in United States.
Trial summary
The purpose of this study is to find answers to the following questions: What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks? What are the side effects of AQ4N when given according to this schedule? How much AQ4N is in the blood at certain times after administration and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- What is being tested?
- AQ4N (Chemotherapy)
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 2007
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
- Tumor specimen available for evaluation (please provide 10 unstained slides)
- Relapse after receiving primary treatment and at least one salvage therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Laboratory test measurements
- Females of childbearing potential must have a negative pregnancy test result within 3 days prior to the first dose and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
- Older than 18 years of age
- Available for periodic blood sampling
Who cannot join
- Certain cardiac problems
- Previous donor stem cell transplant
- Known HIV, Hepatitis B, Hepatitis C infection
- Previous chemotherapy, radiation or other investigational drug treatments within 4 weeks of first planned dose of study drug
- Major surgery within four weeks of first planned dose of study drug
- Any active viral, bacterial, or fungal infection within four weeks of first planned dose of study drug
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Medical College of Cornell University/ New York Presbyterian Hospital
New York, New York, 10021
About this study
Official title: A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms
The purpose of this study is to find answers to the following questions:
- What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
- What are the side effects of AQ4N when given according to this schedule?
- How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
- Will AQ4N help treat lymphoid cancer?
Read the detailed description
All patients in this study will receive AQ4N one time every three weeks for a maximum of 24 weeks. Each patient will receive the same dose for the entire time he/she is on the study. However, some patients may receive a different dose than other patients depending upon when they enter the study.
When the study begins, the first three patients will receive a dose of 400 mg/m2. After they have all been observed for 2 weeks, and if side effects do not occur or are tolerable, another three patients will enter the study at a higher dose. The increase in dose may continue with new patient groups until side effects reach a point where they are not tolerated. At that point no higher doses will be tried and more patients will be allowed to enter at one or two lower doses where the side effects were tolerated.
Up to 55 patients will be entered in this study at up to 8 research centers in the United States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)
The following procedures will be completed at the time of screening and throughout the study: review of medical and cancer history, previous cancer treatments, and current medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a computed tomography scan (CT scan) and a bone marrow biopsy.
- Being tested
- AQ4N (Chemotherapy)
- Keywords
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ4N (Chemotherapy)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (3)
Response duration and time to tumor progression
Time to treatment failure
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2005 (estimated)
- Study startMar 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants
Sponsor and investigators
- Lead sponsor
- Novacea
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109356
- Sponsor's protocol ID
- 021-002
- Status last verified
- May 2007
- First submitted
- 27 Apr 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open Label, Dose Escalation Study of AQ4N for Safety, Tolerability, Pharmacokinetics and Activity in Patients With Lymphoid Neoplasms
- ClinicalTrials.gov ID
- NCT00109356
- Acronym / sponsor ID
- 021-002
- Keywords
- Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants
- Lead sponsor
- NovaceaIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Mar 2007
- First posted
- 27 Apr 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.
The purpose of this study is to find answers to the following questions:
- What is the largest dose of AQ4N that can be given safely one time every three weeks for 24 weeks?
- What are the side effects of AQ4N when given according to this schedule?
- How much AQ4N is in the blood at certain times after administration and how does the body get rid of the drug?
- Will AQ4N help treat lymphoid cancer?
Detailed description
All patients in this study will receive AQ4N one time every three weeks for a maximum of 24 weeks. Each patient will receive the same dose for the entire time he/she is on the study. However, some patients may receive a different dose than other patients depending upon when they enter the study.
When the study begins, the first three patients will receive a dose of 400 mg/m2. After they have all been observed for 2 weeks, and if side effects do not occur or are tolerable, another three patients will enter the study at a higher dose. The increase in dose may continue with new patient groups until side effects reach a point where they are not tolerated. At that point no higher doses will be tried and more patients will be allowed to enter at one or two lower doses where the side effects were tolerated.
Up to 55 patients will be entered in this study at up to 8 research centers in the United States. Study duration will be approximately 27 weeks or 8 treatment cycles (One treatment cycle lasts 3 weeks and begins on Day 1 with an infusion of AQ4N.)
The following procedures will be completed at the time of screening and throughout the study: review of medical and cancer history, previous cancer treatments, and current medications, a complete physical exam, and blood (4 to 6 teaspoons) and urine tests. Two additional tests to evaluate the heart, an electrocardiogram (ECG) and a multiple gated acquisition assessment (MUGA) will be performed. Cancer progression will be monitored by a computed tomography scan (CT scan) and a bone marrow biopsy.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 (8 listed)
- Diagnosis of Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia
- Tumor specimen available for evaluation (please provide 10 unstained slides)
- Relapse after receiving primary treatment and at least one salvage therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Laboratory test measurements
Key exclusion criteria (7 listed)
- Certain cardiac problems
- Previous donor stem cell transplant
- Known HIV, Hepatitis B, Hepatitis C infection
- Previous chemotherapy, radiation or other investigational drug treatments within 4 weeks of first planned dose of study drug
- Major surgery within four weeks of first planned dose of study drug
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 |
|---|---|---|
| AQ4N (Chemotherapy) | Drug | – |
Primary outcome
Overall response rate
3 secondary outcomes
Response duration and time to tumor progression
Time to treatment failure
Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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 1/2 study testing AQ4N (Chemotherapy) in people with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia, run by Novacea 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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 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 combined 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.
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?
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?
Overall response rate. 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 7 May 2007.