LeukemiaPhase 2NCT01656031
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
A Phase 2 study testing clofarabine and cytarabine in people with Leukemia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Leukemia
- What is being tested?
- clofarabine and cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)
- No M3 AML
- Meets 1 of the following criteria:
- In first relapse
- In second relapse after a second complete remission (CR) that lasted ≥ 3 months
- Refractory to initial induction therapy
- No symptomatic CNS involvement
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 2
- Creatinine < 2 mg/dL
- Bilirubin ≤ 2 mg/dL
- AST and ALT ≤ 4 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
- Ejection fraction ≥ 45% by echocardiogram
- No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
- No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
- No other severe concurrent disease that would preclude study treatment
PRIOR CONCURRENT THERAPY:
- At least 1 week since prior therapy and recovered
- No other concurrent chemotherapy
- Hydroxyurea to control WBC count before starting study treatment allowed
- No concurrent corticosteroids unless used for diseases other than leukemia
- No concurrent palliative radiotherapy
- No concurrent growth factors (e.g., epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) in patients with AML
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
- Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.
OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
- Conditions
- Leukemia
- Being tested
- clofarabine, cytarabine
- Keywords
- recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute basophilic leukemia, adult acute eosinophilic leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute megakaryoblastic leukemia (M7), adult acute minimally differentiated myeloid leukemia (M0), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4)
- Medical subject headings
- Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Congenital Abnormalities, Leukemia, Basophilic, Acute, Leukemia, Eosinophilic, Acute, Leukemia, Erythroblastic, Acute, Leukemia, Megakaryoblastic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clofarabineDrug
cytarabineDrug
| Study group | Role | What they receive |
|---|---|---|
| high-dose cytarabine and clofarabine | Experimental | high-dose cytarabine (2000 milligram/meter squared/day) administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days Receives: Drug: clofarabine; Drug: cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startFeb 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bayard L. Powell, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656031
- Sponsor's protocol ID
- 21204 Phase 2
- Other IDs
- CCCWFU-21204, ILEX-CCCWFU-21204, CCCWFU-BG04-519
- Status last verified
- Feb 2017
- First submitted
- 31 Jul 2012
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT01656031
- Acronym / sponsor ID
- 21204 Phase 2
- Conditions
- Leukemia
- Keywords
- recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute basophilic leukemia, adult acute eosinophilic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
- Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.
OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-dose cytarabine and clofarabine | Experimental | Drug: clofarabine, Drug: cytarabinehigh-dose cytarabine (2000 milligram/meter squared/day) administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 | high-dose cytarabine and clofarabine |
| cytarabine | Drug | high-dose cytarabine and clofarabine |
Primary outcome
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML
Time frame: 5 weeks
Response to the therapy is measured by a defined improvement in Neutrophil and platlet counts, along with improved cellularity of bone marrow biopsy (>20% with maturation of all cell lines), <5% blasts, auer rods must not be detectable and extramedullary leukemia or soft tissue involvment must not be present.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bayard L. Powell, MD study chair
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clofarabine and cytarabine in people with Leukemia, run by Wake Forest University Health Sciences 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?
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 20 Jun 2017. 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 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?
Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measure Patient Response to High-dose Cytarabine Followed by Clofarabine in Adult Patients With Relapsed or Refractory AML (time frame: 5 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 20 Jun 2017.