Chronic Lymphocytic LeukemiaPhase 1NCT00081887
Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
A Phase 1 study testing Clofarabine in people with Chronic Lymphocytic Leukemia and Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL). 2. To determine the toxicity profile of clofarabine in CLL. 3. To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Leukemia
- What is being tested?
- Clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jun 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen.
- Absolute neutrophil count (ANC) >= 1 x 10(9)/L and platelet count >= 50 x 10(9)/L
- Adequate liver function (total bilirubin <= 1.5 x ULN, SGPT <= 2.5 x ULN) and renal function (serum creatine <= 1.5 x ULN).
- ECOG performance status <= 2.
Who cannot join
- Patients with NYHA >= grade 3 heart disease as assessed by history and/or physical examination
- Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception.
- Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
- Other malignancy within 3 years except in situ carcinoma
- Unwilling or unable to provide informed consent
- Hypersensitivity to nucleoside analogues
- Other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within 6 months, ventricular arrhythmia, diabetes, active infection, pulmonary fibrosis, and chronic hepatitis
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL).
- To determine the toxicity profile of clofarabine in CLL.
- To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
Read the detailed description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical examination. You will also be asked about what medications you are taking currently and about the level of your daily activities. Routine blood tests (about 2 tablespoons) will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects. You may have bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.
If you are found to be eligible, you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks. This cycle makes up one treatment course.
The drug is evaluated at different dose levels. The first three patients will start with a lower dose. Unless serious side effects occur, the next group of patients (usually groups are 3 patients, although they can be expanded to include more patients if needed) will receive a higher dose.
If you show a response and do not experience any severe side effects, you can receive up to a total of 6 courses of therapy. During each course, clofarabine is given the same way as during the first course. However, the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Before every treatment course, your doctor will perform a physical exam, including measurement of your weight and vital signs. You will be asked about the level of your daily activities and how you are feeling. At least once every two weeks (more often if your doctor feels it is necessary), you will have blood samples (about 1-2 teaspoons) collected for routine lab tests. Repeat bone marrows will be collected after the third and sixth course. However, if you complete the study before the third course, the bone marrow may be taken then. No bone marrow may be taken if the condition of your disease is obvious from the blood.
You will need to stay in Houston for the first 4 weeks of treatment. After that, you may return to your home but you will still have to return to Houston to receive the clofarabine treatment. You may choose to have check-up visits and blood tests with your local doctor.
After you finished your treatment, and as long you are participating on this study, you will be scheduled every 3-6 months to check on the status of the disease and your overall health.
This is an investigational study. Clofarabine is authorized by the FDA for use in research only. Up to 36 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia
- Being tested
- Clofarabine
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Leukemia, Clofarabine, Clofarex, Clolar
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
Also called Clofarex, Clolar
Starting dose is 10 mg/m^2 as a 1-hour infusion into a vein once every 2 weeks for 4 weeks (1 cycle).
| Study group | Role | What they receive |
|---|---|---|
| Weekly Clofarabine | Experimental | Not described Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: Following each 4 week treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2004 (estimated)
- Study startMay 2004
- Primary completionMay 2007
- Study completionJun 2007
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Stefan Faderl, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081887
- Sponsor's protocol ID
- 2004-0134
- Status last verified
- Jul 2012
- First submitted
- 23 Apr 2004
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00081887
- Acronym / sponsor ID
- 2004-0134
- Conditions
- Chronic Lymphocytic Leukemia, Leukemia
- Keywords
- Chronic Lymphocytic Leukemia, CLL, Leukemia, Clofarabine, Clofarex, Clolar
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- May 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 27 Apr 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.
Primary Objectives:
- To determine the maximum tolerated dose (MTD) of clofarabine in Chronic Lymphocytic Leukemia (CLL).
- To determine the toxicity profile of clofarabine in CLL.
- To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile of clofarabine in CLL.
Detailed description
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical examination. You will also be asked about what medications you are taking currently and about the level of your daily activities. Routine blood tests (about 2 tablespoons) will be done within 14 days before the start of the study to make sure that you are not at increased risk for developing side effects. You may have bone marrow samples collected. To collect a bone marrow sample, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow is withdrawn through a large needle.
If you are found to be eligible, you will receive clofarabine as a 1-hour infusion into a vein once once every 2 weeks for 4 weeks. This cycle makes up one treatment course.
The drug is evaluated at different dose levels. The first three patients will start with a lower dose. Unless serious side effects occur, the next group of patients (usually groups are 3 patients, although they can be expanded to include more patients if needed) will receive a higher dose.
If you show a response and do not experience any severe side effects, you can receive up to a total of 6 courses of therapy. During each course, clofarabine is given the same way as during the first course. However, the dose of clofarabine may be lowered during later courses to decrease the risk of side effects that may have occurred in previous courses. If the disease gets worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
Before every treatment course, your doctor will perform a physical exam, including measurement of your weight and vital signs. You will be asked about the level of your daily activities and how you are feeling. At least once every two weeks (more often if your doctor feels it is necessary), you will have blood samples (about 1-2 teaspoons) collected for routine lab tests. Repeat bone marrows will be collected after the third and sixth course. However, if you complete the study before the third course, the bone marrow may be taken then. No bone marrow may be taken if the condition of your disease is obvious from the blood.
You will need to stay in Houston for the first 4 weeks of treatment. After that, you may return to your home but you will still have to return to Houston to receive the clofarabine treatment. You may choose to have check-up visits and blood tests with your local doctor.
After you finished your treatment, and as long you are participating on this study, you will be scheduled every 3-6 months to check on the status of the disease and your overall health.
This is an investigational study. Clofarabine is authorized by the FDA for use in research only. Up to 36 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weekly Clofarabine | Experimental | Drug: Clofarabine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB), and PLL (B- and T-cell phenotypes) who have relapsed from or are refractory to at least one fludarabine-based regimen.
- Absolute neutrophil count (ANC) >= 1 x 10(9)/L and platelet count >= 50 x 10(9)/L
- Adequate liver function (total bilirubin <= 1.5 x ULN, SGPT <= 2.5 x ULN) and renal function (serum creatine <= 1.5 x ULN).
- ECOG performance status <= 2.
Key exclusion criteria (7 listed)
- Patients with NYHA >= grade 3 heart disease as assessed by history and/or physical examination
- Pregnant or breastfeeding women or patients who are unwilling or unable to practice adequate contraception.
- Chemotherapy within 4 weeks of starting therapy, or concurrent anticancer therapy (chemotherapy, radiotherapy, or biologic therapy)
- Other malignancy within 3 years except in situ carcinoma
- Unwilling or unable to provide informed consent
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 |
|---|---|---|
| ClofarabineAlso: Clofarex, ClolarStarting dose is 10 mg/m^2 as a 1-hour infusion into a vein once every 2 weeks for 4 weeks (1 cycle). | Drug | Weekly Clofarabine |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Following each 4 week treatment cycle
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Stefan Faderl, MD 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 1 study testing Clofarabine in people with Chronic Lymphocytic Leukemia and Leukemia, run by M.D. Anderson Cancer Center 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 4 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: stopped early, as of the sponsor's last update on 1 Aug 2012. 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 (reason given: low accrual). 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?
Maximum tolerated dose (MTD) (time frame: Following each 4 week treatment cycle). 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 1 Aug 2012.