Acute Myelogenous LeukemiaPhase 2NCT00098033
Investigation of Clofarabine in Acute Leukemias
A Phase 2 study testing clofarabine in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by University of Texas.
Trial summary
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- clofarabine
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Sep 2005
- Phase
- Phase 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Patient is diagnosed with AML, ALL, myelodysplastic syndrome (MDS), and CML in transformation (includes CML-blastic phase and CML-accelerated phase).
- No prior chemo-, immuno-, or radio-therapy for 2 weeks before entering the study, unless progressive life-threatening leukemia as judged by the treated physician.
- Adequate liver function (bilirubin </= 2 mg%) and renal function (creatinine </= 2 mg%).
- Pregnant and lactating females not eligible.
- Zubrod performance status 0-2
- Adequate cardiac status
- No life-threatening conditions (e.g. infections) which may cause death within 3 weeks.
About this study
Official title: Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.
Read the detailed description
The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.
Completion date provided represents the completion date of the grant per OOPD records
- Being tested
- clofarabine
- Keywords
- clinical, pharmacodynamics, investigational drug clofarabine, AML, ALL, CML-accelerated phase, CML-blastic phase, Chronic Myelogenous Leukemia - accelerated phase, Chronic Myelogenous Leukemia - blastic phase
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Accelerated Phase, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofarabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2004 (estimated)
- Study startSep 2002
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myelogenous 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- University of Texas
- Sponsor type
- University, hospital or other
- Investigators
- Hagop M Kantarjian, MD, Principal investigator, M.D. Anderson Cancer CenterJorge E Cortes, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00098033
- Sponsor's protocol ID
- 2127
- Status last verified
- Dec 2004
- First submitted
- 2 Dec 2004
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Cortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical and Pharmacodynamic Investigation of Clofarabine in Acute Leukemias
- ClinicalTrials.gov ID
- NCT00098033
- Acronym / sponsor ID
- 2127
- Keywords
- clinical, pharmacodynamics, investigational drug clofarabine, AML, ALL, CML-accelerated phase, CML-blastic phase, Chronic Myelogenous Leukemia - accelerated phase, Chronic Myelogenous Leukemia - blastic phase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- University of TexasUniversity, hospital or other
- Study start
- Sep 2002
- Study completion
- Sep 2005
- First posted
- 3 Dec 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.
The goals and objectives of this project are to evaluate the antileukemic activity of the investigational agent clofarabine in patients with acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and chronic myelogenous leukemia (CML) in accelerated and blastic phases.
Detailed description
The specific aims of the project are (1) conduct the phase II study of clofarabine and evaluate the antileukemic efficacy in AML, ALL, and CML-accelerated and blastic phases in terms of complete response (CR) rate, response duration, and survival; and (2) analyze the relationship between cellular uptake and retention of clofarabine triphosphate (the active metabolite), inhibition of DNA synthesis, and clinical outcome.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| clofarabine | Drug | – |
Primary outcome
Not reported in the source record.
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 25 Mar 2015.
- BackgroundCortes JE, Gandhi V, et al. Clofarabine (2-chloro-9-(deoxy-2-fluoro-b-D-arabinosfuranosyl)adenine) is active for patients with refractory or relapsed acute leukemia. #739 ASH 2002.
- FDA's clinical trials websiteLink provided by the sponsor.
Related trials for Acute Myelogenous Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Hagop M Kantarjian, MD principal investigator
M.D. Anderson Cancer Center
Jorge E Cortes, MD study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clofarabine in people with Acute Myelogenous Leukemia and Acute Lymphocytic Leukemia, run by University of Texas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00098033, which also lists 1 linked publication.
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 25 Mar 2015.