Lymphoblastic Leukemia, Acute, ChildhoodPhase 1NCT00991133
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
A Phase 1 study testing Clofarabine incorporated into a 5-drug regimen in people with Lymphoblastic Leukemia, Acute, Childhood, run by Genzyme, a Sanofi Company at 6 sites in United States.
Trial summary
This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL). Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Lymphoblastic Leukemia, Acute, Childhood
- What is being tested?
- Clofarabine incorporated into a 5-drug regimen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2009to Apr 2011
- 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be in first relapse with >25% blasts in the bone marrow with a duration of first remission of ≥6 months and no longer in the intensive phase(s) of initial ALL therapy (e.g., patients who are in the maintenance or continuation phases of therapy [or beyond] and who have completed the induction or intensification phases).
- Have received no more than 2 prior induction regimens prior to the date of first relapse. Patients who are in first relapse but have failed a re-induction attempt (i.e., 1 cycle of re-induction therapy) are not eligible for inclusion in this study.
- Be ≥1 and ≤30 years old and have a body weight of >10 kg at study entry. (Note: no more than 3 patients aged >21 ≤30 are to be enrolled.)
- Be able to receive all study drugs with no known contra-indications.
- Be able to provide adequate venous access.
- Have a Karnofsky Performance Status (KPS) of ≥50 for patients >10 years of age or a Lansky Performance Status (LPS) of ≥50 for patients ≤10 years of age.
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- Patients (≥18 years of age) or the parent or legal guardian(s) (for patients <18 years of age) must provide signed, written informed consent according to local institutional review board (IRB) and institutional requirements. For patients <18 years of age, signed assent should be obtained according to local IRB and institutional requirements.
- Be able to comply with study procedures and follow-up examinations.
- Have adequate liver, renal, pancreatic, and cardiac function considered acceptable by laboratory values and cardiac assessments
- Have no active central nervous system (CNS) leukemia, as evidenced by negative cytology on lumbar puncture and absence of clinical central neurologic symptoms. Diagnostic lumbar puncture should be performed only after all other eligibility assessments have been completed and reviewed, except for bone marrow aspirate and/or biopsy. Patients with CNS1 or CNS2 leukemia may be enrolled in the study.
- Have recovered to baseline from all toxicities from prior chemotherapy regimens prior to enrollment in the study.
Who cannot join
- Have received previous treatment with clofarabine.
- Have a history of clinical allergy (Grade 3 or 4) to PEG-asparaginase.
- Have a history of severe pancreatitis (Grade 3 or 4) attributed to asparaginase therapy.
- Have Burkitt's leukemia.
- Have overt testicular relapse.
- Adequate time has not elapsed since patient's last therapy. Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a washout period before entry onto this study. Note that patients may receive intrathecal (IT) ara-C, methotrexate, or hydrocortisone immediately prior to the administration of study drugs. Patients may also receive hydroxyurea up to 24 hours prior to the start of study therapy. Patients who relapse when they are not receiving standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior therapy (excluding hematologic toxicity), immunotherapy or radiotherapy.
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- Have an uncontrolled systemic fungal, bacterial, viral, or other infection. For patients with a history of fever within the preceding 3 days at the time of enrollment, documentation of negative blood cultures for at least 48 hours is required.
- Are pregnant or lactating.
- Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc.) while on study therapy, and for a minimum of 1 month following final study visit.
- Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
- Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or pancreas.
- Have received any stem cell transplantation or high-dose chemotherapy with stem cell rescue regimen.
- Have a history of cirrhosis or known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS).
- Have a history of at least 1 positive test for hepatitis B or hepatitis C infection.
- Have Down syndrome.
- Are currently participating in another concurrent investigational treatment protocol.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
The Children's Hospital
Aurora, Colorado, 80045
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois, 60614
Children's Hospital Los Angeles
Los Angeles, California, 90027
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Phase 1, Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) in First Relapse
This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL).
Read the detailed description
The trial is a Phase 1, open-label study to assess the safety and tolerability of incorporating clofarabine into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginase, and vincristine. Patients enrolled in this study will receive a maximum of 2 cycles of the 5-drug regimen, then will be treated according to investigator discretion. After the study treatment period, all patients will be followed for a minimum of 4 months beyond the final study visit. This study will include a maximum of 12 evaluable patients.
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Being tested
- Clofarabine incorporated into a 5-drug regimen
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clofarabine incorporated into a 5-drug regimenDrug
Also called Clolar, VP-16, Cytoxan, PEGaspar-aginase
Clofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Patients received a maximum of 2 cycles of the intravenous (IV) 5-drug regimen (clofarabine, etoposide,cyclophosphamide, PEG-asparaginase, and vincristine) plus intrathecal methotrexate, and then entered follow-up. Patients who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and patients who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion. Receives: Drug: Clofarabine incorporated into a 5-drug regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs)
Measured: 1 cycle
Secondary outcomes (2)
Overall toxicity profile documented by incidence of AEs, SAEs, and/or DLTs
Measured: 1 cycle
Efficacy as documented by complete remission (CR), time and duration of remission, event-free survival (EFS), 4-month EFS, disease-free survival (DFS), and overall survival
Measured: 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoblastic Leukemia, Acute, ChildhoodStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991133
- Sponsor's protocol ID
- CLO08808
- Status last verified
- Apr 2015
- First submitted
- 5 Oct 2009
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) in First Relapse
- ClinicalTrials.gov ID
- NCT00991133
- Acronym / sponsor ID
- CLO08808
- Conditions
- Lymphoblastic Leukemia, Acute, Childhood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Oct 2009 (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.
This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic Leukemia (ALL).
Detailed description
The trial is a Phase 1, open-label study to assess the safety and tolerability of incorporating clofarabine into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginase, and vincristine. Patients enrolled in this study will receive a maximum of 2 cycles of the 5-drug regimen, then will be treated according to investigator discretion. After the study treatment period, all patients will be followed for a minimum of 4 months beyond the final study visit. This study will include a maximum of 12 evaluable patients.
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: Clofarabine incorporated into a 5-drug regimenPatients received a maximum of 2 cycles of the intravenous (IV) 5-drug regimen (clofarabine, etoposide,cyclophosphamide, PEG-asparaginase, and vincristine) plus intrathecal methotrexate, and then entered follow-up. Patients who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and patients who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Be in first relapse with >25% blasts in the bone marrow with a duration of first remission of ≥6 months and no longer in the intensive phase(s) of initial ALL therapy (e.g., patients who are in the maintenance or continuation phases of therapy [or beyond] and who have completed the induction or intensification phases).
- Have received no more than 2 prior induction regimens prior to the date of first relapse. Patients who are in first relapse but have failed a re-induction attempt (i.e., 1 cycle of re-induction therapy) are not eligible for inclusion in this study.
- Be ≥1 and ≤30 years old and have a body weight of >10 kg at study entry. (Note: no more than 3 patients aged >21 ≤30 are to be enrolled.)
- Be able to receive all study drugs with no known contra-indications.
- Be able to provide adequate venous access.
Key exclusion criteria (16 listed)
- Have received previous treatment with clofarabine.
- Have a history of clinical allergy (Grade 3 or 4) to PEG-asparaginase.
- Have a history of severe pancreatitis (Grade 3 or 4) attributed to asparaginase therapy.
- Have Burkitt's leukemia.
- Have overt testicular relapse.
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 incorporated into a 5-drug regimenAlso: Clolar, VP-16, Cytoxan, PEGaspar-aginaseClofarabine (IV) 40mg/m2 into an intensive chemotherapy regimen of etoposide, cyclophosphamide, PEG-asparaginas, and vincristine | Drug | Clofarabine |
Primary outcome
The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs)
Time frame: 1 cycle
2 secondary outcomes
Overall toxicity profile documented by incidence of AEs, SAEs, and/or DLTs
Time frame: 1 cycle
Efficacy as documented by complete remission (CR), time and duration of remission, event-free survival (EFS), 4-month EFS, disease-free survival (DFS), and overall survival
Time frame: 2 cycles
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 30 Apr 2015.
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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.
Medical Monitor study director
Genzyme, a Sanofi Company
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clofarabine incorporated into a 5-drug regimen in people with Lymphoblastic Leukemia, Acute, Childhood, run by Genzyme, a Sanofi Company at 6 sites 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 11 inclusion and 16 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The incidence of DLTs (Dose Limiting Toxicities) experienced with 1 cycle of this 5-drug regimen in this patient population (in all patients who receive any doses of study drugs) (time frame: 1 cycle). 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 30 Apr 2015.