LeukemiaPhase 1NCT00800566
Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)
A Phase 1 study testing Oral Clofarabine in people with Leukemia and Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Chronic Lymphocytic Leukemia
- What is being tested?
- Oral Clofarabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Apr 2009
- 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
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB [French-American-British Classification]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
- Absolute neutrophil count (ANC) >= 1 x 109/L and platelet count >= 50 x 109/L.
- Adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dL; if serum creatinine > 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin </= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) </= 2.5 x ULN; alkaline phosphatase </= 2.5 x ULN.
- ECOG performance status <= 2.
- Age >/= 18 years.
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. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
- 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.
- Known hypersensitivity to nucleoside analogues.
- Any other significant medical condition that compromises safety, compliance or study conduct, including but not limited to uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, ventricular arrhythmia, active infection, and known 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 Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
The goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Screening Tests:
Before you can begin taking the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will also be asked about what drugs you are currently taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will also have a bone marrow aspirate and/or biopsy. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.
- Women who are able to have children must have a negative blood or urine pregnancy test. The blood would be drawn as part of the routine sample described above.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of clofarabine based on when you joined this study. Up to 7 dose levels of clofarabine will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of clofarabine is found.
The dose of clofarabine may be lowered or delayed to help reduce side effects.
Study Drug Administration:
On Days 1-21 of each 28-day study "cycle", you will take clofarabine by mouth once a day (in the morning) at about the same time everyday.
- You should take clofarabine on an empty stomach.
- You should try to fast (not eat anything or drink anything other than water) from midnight the night before each dose to 1 hour after taking clofarabine.
- Clofarabine should be taken with 4 ounces (1/2 a cup) of water.
- You should not drink coffee and other caffeinated liquids before and for 1 hour after taking the study drug.
- If you vomit more than 15 minutes after you take the drug, you should not replace or make up the drug. If you vomit less then 15 minutes after taking the drug, you should retake the dose. If you vomit again within 15 minutes after retaking the dose, you should not take the drug again that day and make a note of it in the diary.
Study Visits:
- On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a performance status evaluation.
- You will be asked if you have experienced any intolerable side effects and how you are feeling.
Once a week of Cycle 1, you will have a physical exam.
Once a week of every cycle, blood (about 1-2 teaspoons) will be drawn for routine tests (blood counts with platelets). Your blood will be drawn more often if the doctor feels it is necessary.
After Cycles 3 and 6, you will have a bone marrow aspiration and/or biopsy to check the status of the disease.
If you go off study before Cycle 3 and the doctor thinks it is necessary, the bone marrow aspiration and/or biopsy may be taken when you go off study.
If you have completed all 6 cycles of the study drug, every 6 months (+/- 2 months), you will have a physical exam and blood (about 1-2 teaspoons) will be drawn to check on the status of the disease and your overall health. The study doctor will tell you any other tests that may be needed.
Length of Study You will be on the study drug for up to 6 cycles (about 6 months). You will be taken off study early if the disease gets worse or you experience any intolerable side effects.
Additional Information:
You will need to stay in Houston for Cycle 1 (28 days). After that, you may return to your home but you will still have to return to Houston before each cycle unless you choose to have check-up visits and blood tests with your local doctor.
This is an investigational study. Clofarabine is FDA approved and commercially available when given by vein to pediatric patients for the treatment of acute lymphoblastic leukemia (ALL) that has come back or not responded to other treatments. The use of clofarabine by mouth is not FDA approved. At this time, oral clofarabine is only being used in research.
Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia
- Being tested
- Oral Clofarabine
- Keywords
- Clofarabine, Leukemia, Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral ClofarabineDrug
Also called Clolar®
The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Oral Clofarabine | Experimental | Not described Receives: Drug: Oral Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)
Measured: October 2009
Secondary outcomes (1)
To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL.
Measured: October 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Sponsor terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 0 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 F. Faderl, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800566
- Sponsor's protocol ID
- 2007-0905
- Status last verified
- Jul 2012
- First submitted
- 1 Dec 2008
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 Oral Clofarabine for the Treatment of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00800566
- Acronym / sponsor ID
- 2007-0905
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia
- Keywords
- Clofarabine, Leukemia, Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Dec 2008 (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 goal of this clinical research study is to find the highest tolerable dose of clofarabine when given to patients with CLL. The safety of this drug will also be studied.
Detailed description
The Study Drug:
Clofarabine is designed to interfere with the growth and development of cancer cells.
Screening Tests:
Before you can begin taking the study drug, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- You will also be asked about what drugs you are currently taking.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will also have a bone marrow aspirate and/or biopsy. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle.
- Women who are able to have children must have a negative blood or urine pregnancy test. The blood would be drawn as part of the routine sample described above.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of clofarabine based on when you joined this study. Up to 7 dose levels of clofarabine will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of clofarabine is found.
The dose of clofarabine may be lowered or delayed to help reduce side effects.
Study Drug Administration:
On Days 1-21 of each 28-day study "cycle", you will take clofarabine by mouth once a day (in the morning) at about the same time everyday.
- You should take clofarabine on an empty stomach.
- You should try to fast (not eat anything or drink anything other than water) from midnight the night before each dose to 1 hour after taking clofarabine.
- Clofarabine should be taken with 4 ounces (1/2 a cup) of water.
- You should not drink coffee and other caffeinated liquids before and for 1 hour after taking the study drug.
- If you vomit more than 15 minutes after you take the drug, you should not replace or make up the drug. If you vomit less then 15 minutes after taking the drug, you should retake the dose. If you vomit again within 15 minutes after retaking the dose, you should not take the drug again that day and make a note of it in the diary.
Study Visits:
- On Day 1 of every cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will have a performance status evaluation.
- You will be asked if you have experienced any intolerable side effects and how you are feeling.
Once a week of Cycle 1, you will have a physical exam.
Once a week of every cycle, blood (about 1-2 teaspoons) will be drawn for routine tests (blood counts with platelets). Your blood will be drawn more often if the doctor feels it is necessary.
After Cycles 3 and 6, you will have a bone marrow aspiration and/or biopsy to check the status of the disease.
If you go off study before Cycle 3 and the doctor thinks it is necessary, the bone marrow aspiration and/or biopsy may be taken when you go off study.
If you have completed all 6 cycles of the study drug, every 6 months (+/- 2 months), you will have a physical exam and blood (about 1-2 teaspoons) will be drawn to check on the status of the disease and your overall health. The study doctor will tell you any other tests that may be needed.
Length of Study You will be on the study drug for up to 6 cycles (about 6 months). You will be taken off study early if the disease gets worse or you experience any intolerable side effects.
Additional Information:
You will need to stay in Houston for Cycle 1 (28 days). After that, you may return to your home but you will still have to return to Houston before each cycle unless you choose to have check-up visits and blood tests with your local doctor.
This is an investigational study. Clofarabine is FDA approved and commercially available when given by vein to pediatric patients for the treatment of acute lymphoblastic leukemia (ALL) that has come back or not responded to other treatments. The use of clofarabine by mouth is not FDA approved. At this time, oral clofarabine is only being used in research.
Up to 36 patients 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 |
|---|---|---|
| Oral Clofarabine | Experimental | Drug: Oral Clofarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic lymphocytic leukemia (CLL), CLL/PLL (as defined by FAB [French-American-British Classification]), small lymphocytic lymphoma (SLL) and prolymphocytic leukemia (PLL) who have relapsed from or are refractory to at least one fludarabine-based regimen and no greater than 2 regimens.
- Absolute neutrophil count (ANC) >= 1 x 109/L and platelet count >= 50 x 109/L.
- Adequate organ function as indicated by the following laboratory values: serum creatinine </= 1 mg/dL; if serum creatinine > 1 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease equation; serum bilirubin </= 1.5 mg/dL x ULN; aspartate transaminase (AST)or alanine transaminase (ALT) </= 2.5 x ULN; alkaline phosphatase </= 2.5 x ULN.
- ECOG performance status <= 2.
- Age >/= 18 years.
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. Positive pregnancy test for women of child bearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization).
- 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 |
|---|---|---|
| Oral ClofarabineAlso: Clolar®The starting dose will be 1 mg orally daily x 21 days every 4 weeks +/- 4 days. | Drug | Oral Clofarabine |
Primary outcome
Maximum tolerated dose (MTD) and Dose limiting toxicities (DLT)
Time frame: October 2009
1 secondary outcome
To investigate the plasma clofarabine and cellular clofarabine triphosphate pharmacology profile in CLL.
Time frame: October 2010
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- M.D. Anderson's 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 F. Faderl, M.D. 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 Oral Clofarabine in people with Leukemia and Chronic Lymphocytic 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 5 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: withdrawn, 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 withdrawn before enrolling participants, so there are no results.
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) and Dose limiting toxicities (DLT) (time frame: October 2009). 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.