LeukemiaPhase 1NCT00714103
8-Chloro-Adenosine in Chronic Lymphocytic Leukemia
A Phase 1 study testing 8-Chloro-Adenosine 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 safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia. 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?
- 8-Chloro-Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Oct 2016
- 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 must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
- Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
- All patients must have a Zubrod performance status of </= 2.
- All patients must be age >/= 18 years.
- Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
- All patients must have adequate renal function indicated by serum creatinine </=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST </= 2.5x ULN AND total bilirubin </= 2.5x ULN.
- All patients must have a pre-treatment platelet count of >/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
- All patients or appropriate surrogate must provide informed consent.
Who cannot join
- Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
- Patients with active uncontrolled fungal, bacterial, or viral infection.
- Patients who are pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Study of 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia.
Read the detailed description
8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of chemotherapy drugs called purine analogues that work to treat cancer by their ability to interfere with cancer cell metabolism, causing cell death.
If you are eligible, you will receive 8-chloro-adenosine as an infusion into a vein once a day for five days in a row. Each infusion will take about 1 hour. This 5-day treatment will be repeated every 4 weeks (± 3 days) (1 course).
This is a dose escalation study. Patients treated on this study will be treated in groups of 3. The first group will receive the lowest dose of the drug. If the type, number, and severity of any side effects experienced are acceptable, the next group of 3 patients will receive the next higher dose of drug. The dose of drug will be increased for each new group until the highest safe dose is found.
For your first course only, you will have blood tests (about 1 tablespoon) on Day 3 and Day 5 of treatment to monitor for safety. After that, you will have weekly (± 3 days) evaluations and routine blood tests (about 1 tablespoon) in the clinic at University of Texas MD Anderson Cancer Center (UTMDACC). During these evaluations, you will also have a physical exam and be asked about any side effects you may have experienced. You will be evaluated for improvement in your CLL. If your disease is stable or responding to treatment, you may continue with treatment. If your disease improves to the point that your doctor feels that you are in complete remission, he or she will request you to have a bone marrow biopsy to confirm complete remission.
If your disease is worsening and it appears that the treatment is not helping you, then you will stop treatment with 8-chloro-adenosine and may begin other treatment at the direction of your treating doctor. If you have unacceptable side effects, you may be taken off treatment.
If you stop treatment, you will be evaluated in the clinic and have routine blood tests (about 1 tablespoon) once a week for the first month, twice a month for the next 2 months, then once a month from then on. During these evaluations, you will have a physical exam and be asked about any side effects you may have experienced. If you begin other treatment, your scheduled follow-up will end.
This is an investigational study. 8-Chloro-adenosine is not approved by the FDA and is not commercially available. A total of up to 28 patients will take part in this study. All will be enrolled and treated at MD Anderson.
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia
- Being tested
- 8-Chloro-Adenosine
- Keywords
- Leukemia, Chronic Lymphocytic Leukemia, CLL, 8-Chloro-Adenosine, purine analogues, Cancer
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-Chloro-AdenosineDrug
45 mg/m^2 intravenous over 1 hour daily for 5 days every 4 weeks (± 3 days).
| Study group | Role | What they receive |
|---|---|---|
| 8-Chloro-Adenosine | Experimental | Starting dose for first cohort of patients 45 mg/m2 intravenous over 1 hr daily for 5 days every 4 weeks (± 3 days). Receives: Drug: 8-Chloro-Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity and Maximum Tolerated Dose
During first course of treatment blood tests on Days 3 and 5; then weekly (± 3 days) evaluations and routine blood tests. Toxicity evaluation completed four weeks following initial 8-Chloro-adenosine administration.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2016
- Study completionOct 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), FDA Office of Orphan Products Development
- Responsible party
- Sponsor
- Investigators
- William G. Wierda, M.D., Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714103
- Sponsor's protocol ID
- 2004-0144
- Other IDs
- NCI-2012-01679
- Status last verified
- Oct 2016
- First submitted
- 10 Jul 2008
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of 8-Chloro-Adenosine in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
- ClinicalTrials.gov ID
- NCT00714103
- Acronym / sponsor ID
- 2004-0144
- Conditions
- Leukemia, Chronic Lymphocytic Leukemia
- Keywords
- Leukemia, Chronic Lymphocytic Leukemia, CLL, 8-Chloro-Adenosine, purine analogues, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), FDA Office of Orphan Products Development
- Study start
- Jun 2008
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 14 Jul 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 safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to learn how effective the drug is at treating leukemia.
Detailed description
8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of chemotherapy drugs called purine analogues that work to treat cancer by their ability to interfere with cancer cell metabolism, causing cell death.
If you are eligible, you will receive 8-chloro-adenosine as an infusion into a vein once a day for five days in a row. Each infusion will take about 1 hour. This 5-day treatment will be repeated every 4 weeks (± 3 days) (1 course).
This is a dose escalation study. Patients treated on this study will be treated in groups of 3. The first group will receive the lowest dose of the drug. If the type, number, and severity of any side effects experienced are acceptable, the next group of 3 patients will receive the next higher dose of drug. The dose of drug will be increased for each new group until the highest safe dose is found.
For your first course only, you will have blood tests (about 1 tablespoon) on Day 3 and Day 5 of treatment to monitor for safety. After that, you will have weekly (± 3 days) evaluations and routine blood tests (about 1 tablespoon) in the clinic at University of Texas MD Anderson Cancer Center (UTMDACC). During these evaluations, you will also have a physical exam and be asked about any side effects you may have experienced. You will be evaluated for improvement in your CLL. If your disease is stable or responding to treatment, you may continue with treatment. If your disease improves to the point that your doctor feels that you are in complete remission, he or she will request you to have a bone marrow biopsy to confirm complete remission.
If your disease is worsening and it appears that the treatment is not helping you, then you will stop treatment with 8-chloro-adenosine and may begin other treatment at the direction of your treating doctor. If you have unacceptable side effects, you may be taken off treatment.
If you stop treatment, you will be evaluated in the clinic and have routine blood tests (about 1 tablespoon) once a week for the first month, twice a month for the next 2 months, then once a month from then on. During these evaluations, you will have a physical exam and be asked about any side effects you may have experienced. If you begin other treatment, your scheduled follow-up will end.
This is an investigational study. 8-Chloro-adenosine is not approved by the FDA and is not commercially available. A total of up to 28 patients will take part in this study. All will be enrolled and treated at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8-Chloro-Adenosine | Experimental | Drug: 8-Chloro-AdenosineStarting dose for first cohort of patients 45 mg/m2 intravenous over 1 hr daily for 5 days every 4 weeks (± 3 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
- Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time </= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
- All patients must have a Zubrod performance status of </= 2.
- All patients must be age >/= 18 years.
- Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
Key exclusion criteria (3 listed)
- Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
- Patients with active uncontrolled fungal, bacterial, or viral infection.
- Patients who are pregnant or breast-feeding.
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 |
|---|---|---|
| 8-Chloro-Adenosine45 mg/m^2 intravenous over 1 hour daily for 5 days every 4 weeks (± 3 days). | Drug | 8-Chloro-Adenosine |
Primary outcome
Dose-limiting Toxicity and Maximum Tolerated Dose
Time frame: 4 weeks
During first course of treatment blood tests on Days 3 and 5; then weekly (± 3 days) evaluations and routine blood tests. Toxicity evaluation completed four weeks following initial 8-Chloro-adenosine administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- University of Texas 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.
William G. Wierda, 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 8-Chloro-Adenosine 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 13 Oct 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dose-limiting Toxicity and Maximum Tolerated Dose (time frame: 4 weeks). 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 13 Oct 2016.