LeukemiaPhase 2NCT00724009
Clofarabine Bone Marrow Cytoreduction
A Phase 2 study testing Clofarabine in people with Leukemia, run by University of Chicago at 1 site in United States.
Trial summary
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- Adequate hepatobiliary function as indicated by the following laboratory values:
- SGOT/SGPT <=2.5 x upper limit of normal
- Alkaline phosphatase <=2.5 x upper limit of normal
- Serum bilirubin < 1.5 mg/dl
- Adequate renal function as indicated by the following laboratory values:
Show all 14Show fewer
- Creatinine Clearance >50 ml/min
- Age >/=18 years
- Zebroid performance status </= 2 (See Appendix A)
- Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
- No evidence of chronic active hepatitis or cirrhosis.
- HIV-negative
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Who cannot join
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Pregnant or lactating patients.
- Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago hospitals
Chicago, Illinois, 60637
About this study
Official title: Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases.
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.
Read the detailed description
Screening will be done prior to enrollment in the study. The following will be done as part of the screening process:
- Medical history review
- Physical exam
- Measurement of vital Signs
- Blood tests (approximately 6 teaspoons of blood) will be done to see if the liver and kidneys are healthy, HIV (the virus that causes AIDS) test for this study and pregnancy test.
- Urine test
- Bone marrow biopsy and aspirate
If the patient is ineligible or does not have a donor for Allogeneic Stem Cell transplantation, you will not be able to participate in this clinical trial.
After results of these tests are obtained, your doctor will decide whether you can participate in this study.
Study procedures:
The study drug will be given for 5 days.
Days 1 through 5:
The patient will receive dexamethasone 1.5 hours prior to the administration of Clofarabine as part of standard care for subjects receiving Clofarabine.
The patient will receive an intravenous (IV) injection (into the vein) of Clofarabine each day for 5 days. This injection is given in the hospital and will be given over approximately 60 minutes each day. The actual dose of Clofarabine is based on the weight and height of the subject.
The patient will have the following tests done to see the effects of the study drug:
Each day of Clofarabine administration, on day 12 and then each day until stem cell transplantation:
- Physical exam
- Vital signs
- Blood tests. About 3-4 teaspoons will be taken each time.
Day 12 after Clofarabine administration and then as outlined for stem cell transplantation:
- Bone marrow biopsy and aspirate.
After Clofarabine administration, there will be short resting period of 7-14 days. After the resting period, the patient will start receiving conditioning chemotherapy regimen (other standard of care drugs to better prepare your body for the stem cell transplant). This regimen will begin 15-21 days after they first received Clofarabine, and consists of additional treatment (chemotherapy and/or radiation). The type of treatment(s) the patient will receive for conditioning is dependent on the type of disease. In addition, this treatment will be decided by your doctor and is independent of this research. The duration of the conditioning period is variable and may take between 5-8 days. Stem cells are usually given one day after the completion of this regimen, which will be between 21 and 30 days after the patient has first received Clofarabine.
Follow-up Subjects who have a response and proceed with stem cell transplant will be followed weekly for the first three months and then every month for six months, then every two months for 12 months, then every three months for 18 months. The stem cell transplant will be done 21-30 days after first receiving Clofarabine. Subjects who do not go on to stem cell transplant will be followed for 3 months following administration of Clofarabine.
At these visits, the following will be done:
- A physical exam
- Medical history
- Blood tests (about 3 teaspoons blood will be taken) performed.
End of study
At this time, the following tests will be done:
- Physical exam
- Blood tests
- Bone marrow biopsy
- Conditions
- Leukemia
- Being tested
- Clofarabine
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
Also called Clolar
Clofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line.
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytoreductive Response
Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%
Measured: Day 12
Secondary outcomes (7)
Number of Participants With Renal Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Number of Participants With Hepatic (Total Bilirubin) Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Number of Participants With Hepatic (SGOT) Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Number of Participants With Cardiac Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Number of Participants With Skin Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Number of Participants Infection Adverse Events
Treatment-related toxicity was calculated according to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Day 12
Leukemia Free Survival
Time to event analysis used the day of transplant as day 0.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionSep 2012
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 University of ChicagoThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor
- Investigators
- Wendy Stock, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724009
- Sponsor's protocol ID
- 15809B
- Status last verified
- Jan 2014
- First submitted
- 25 Jul 2008
- Last updated
- 18 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases.
- ClinicalTrials.gov ID
- NCT00724009
- Acronym / sponsor ID
- 15809B
- Conditions
- Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 18 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.
Detailed description
Screening will be done prior to enrollment in the study. The following will be done as part of the screening process:
- Medical history review
- Physical exam
- Measurement of vital Signs
- Blood tests (approximately 6 teaspoons of blood) will be done to see if the liver and kidneys are healthy, HIV (the virus that causes AIDS) test for this study and pregnancy test.
- Urine test
- Bone marrow biopsy and aspirate
If the patient is ineligible or does not have a donor for Allogeneic Stem Cell transplantation, you will not be able to participate in this clinical trial.
After results of these tests are obtained, your doctor will decide whether you can participate in this study.
Study procedures:
The study drug will be given for 5 days.
Days 1 through 5:
The patient will receive dexamethasone 1.5 hours prior to the administration of Clofarabine as part of standard care for subjects receiving Clofarabine.
The patient will receive an intravenous (IV) injection (into the vein) of Clofarabine each day for 5 days. This injection is given in the hospital and will be given over approximately 60 minutes each day. The actual dose of Clofarabine is based on the weight and height of the subject.
The patient will have the following tests done to see the effects of the study drug:
Each day of Clofarabine administration, on day 12 and then each day until stem cell transplantation:
- Physical exam
- Vital signs
- Blood tests. About 3-4 teaspoons will be taken each time.
Day 12 after Clofarabine administration and then as outlined for stem cell transplantation:
- Bone marrow biopsy and aspirate.
After Clofarabine administration, there will be short resting period of 7-14 days. After the resting period, the patient will start receiving conditioning chemotherapy regimen (other standard of care drugs to better prepare your body for the stem cell transplant). This regimen will begin 15-21 days after they first received Clofarabine, and consists of additional treatment (chemotherapy and/or radiation). The type of treatment(s) the patient will receive for conditioning is dependent on the type of disease. In addition, this treatment will be decided by your doctor and is independent of this research. The duration of the conditioning period is variable and may take between 5-8 days. Stem cells are usually given one day after the completion of this regimen, which will be between 21 and 30 days after the patient has first received Clofarabine.
Follow-up Subjects who have a response and proceed with stem cell transplant will be followed weekly for the first three months and then every month for six months, then every two months for 12 months, then every three months for 18 months. The stem cell transplant will be done 21-30 days after first receiving Clofarabine. Subjects who do not go on to stem cell transplant will be followed for 3 months following administration of Clofarabine.
At these visits, the following will be done:
- A physical exam
- Medical history
- Blood tests (about 3 teaspoons blood will be taken) performed.
End of study
At this time, the following tests will be done:
- Physical exam
- Blood tests
- Bone marrow biopsy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: ClofarabineClofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- Adequate hepatobiliary function as indicated by the following laboratory values:
- Age >/=18 years
- Zebroid performance status </= 2 (See Appendix A)
- Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
Key exclusion criteria (6 listed)
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- Pregnant or lactating patients.
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: ClolarClofarabine for injection should be diluted with 0.9% sodium chloride injection USP or European Pharmacopeia (EP) normal saline (NS) or 5% dextrose injection (D5W) USP or EP prior to IV infusion. The resulting admixture may be stored at room temperature, but must be used within 24 hours of preparation. Clofarabine should be diluted with NS or D5W prior to administering by IV infusion. The dosage is based on the patient's body surface area (BSA), calculated using the actual height and weight before the start of each cycle. To prevent drug incompatibilities, no other medications should be administered through the same IV line. | Drug | Clofarabine |
Primary outcome
Cytoreductive Response
Time frame: Day 12
Percent of patients achieving cytoreductive response of marrow cellularity <20% and blasts < 10%
7 secondary outcomes
Number of Participants With Renal Adverse Events
Time frame: Day 12
Number of Participants With Hepatic (Total Bilirubin) Adverse Events
Time frame: Day 12
Number of Participants With Hepatic (SGOT) Adverse Events
Time frame: Day 12
Number of Participants With Cardiac Adverse Events
Time frame: Day 12
Number of Participants With Skin Adverse Events
Time frame: Day 12
Number of Participants Infection Adverse Events
Time frame: Day 12
Leukemia Free Survival
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
- 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.
Wendy Stock, MD principal investigator
University of Chicago
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 in people with Leukemia, run by University of Chicago 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 14 inclusion and 6 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 18 Mar 2014. 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 18 Mar 2014). 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?
Cytoreductive Response (time frame: Day 12). 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 18 Mar 2014.