Acute LeukemiaPhase 2/3CLOVENCT01385891
Clove In The Treatment Of Relapsed Or Resistant Acute Leukemia In Children
A Phase 2/3 study testing Clofarabine VP 16 ciclophospahamide in people with Acute Leukemia, run by Istituto Giannina Gaslini at 1 site in Italy.
Trial summary
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric. Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the… Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- Clofarabine VP 16 ciclophospahamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2008to Feb 2010
- Phase
- Phase 2/3
- 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 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- presence of > 25% of blast in bone marrow
- treatment with second line therapies
- patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration
- children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
- Relapsed after > months after SCT
- Karnofsky score >50
Show all 9Show fewer
- a Forced Espiratory Volume >30%
- sufficient hepatic and renal function defined as creatinine levels <2 × ULN, bilirubin <1.5 × ULN
- aspartate and alanine aminotransferases <10 × ULN.
Who cannot join
- isolated extra-medullary relapse, and active infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
- Conditions
- Acute Leukemia
- Being tested
- Clofarabine VP 16 ciclophospahamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clofarabine VP 16 ciclophospahamideDrug
Also called Evoltra, Etoposide, Endoxan
Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| children with advanced leukemia | Experimental | Not described Receives: Drug: Clofarabine VP 16 ciclophospahamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to treatment
Measured: after an expected average of 3 weeks after the first dose of each chemotherapy course
Secondary outcomes (1)
Number of patients with toxicity as a measure of safety and tolerability
Grade of toxicity defined according to the National Cancer's Inst. Common terminology Criteria (NCI CTCAE v3.0)
Measured: at an expected average of 4 weeks after the first dose of each chemotherapy course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Investigators
- Concetta Micalizzi, MD, Principal investigator, G. Gaslini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385891
- Sponsor's protocol ID
- CM001
- Other IDs
- 2008-004487-39, 2008
- Acronym
- CLOVE
- Status last verified
- Jul 2008
- First submitted
- 21 Jun 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine, Cyclophosfamide, And Etoposide For The Treatment Of Relapsed Or Resistant Acute Leukemia In Pediatric Patients
- ClinicalTrials.gov ID
- NCT01385891
- Acronym / sponsor ID
- CLOVE / CM001
- Conditions
- Acute Leukemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 30 Jun 2011 (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.
Study Hypothesis. combination chemotherapy with Clofarabine VP16 and Cyclophosphamide is able to induce remission in resistant/refractory acute leukemias in pediatric.
Forty children with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML) entered the study and received the association of clofarabine (40 mg/m2/day) in combination with etoposide (100 mg/m2/day) and Cyclophosphamide (440 mg/m2/day) in 1 or 2 induction cycles End point were complete remission (CR)or CR without platelet recovery (CRp) and toxicity
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with advanced leukemia | Experimental | Drug: Clofarabine VP 16 ciclophospahamide |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- presence of > 25% of blast in bone marrow
- treatment with second line therapies
- patients with resistant disease i.e. with >25% of blasts 21 days after the last cytostatic agent administration
- children with persistent high MRD level (> 10-3) after first or further line chemotherapy, were considered eligible to the treatment
- Relapsed after > months after SCT
Key exclusion criteria (1 listed)
- isolated extra-medullary relapse, and active infections
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 VP 16 ciclophospahamideAlso: Evoltra, Etoposide, EndoxanClofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour | Drug | children with advanced leukemia |
Primary outcome
response to treatment
Time frame: after an expected average of 3 weeks after the first dose of each chemotherapy course
1 secondary outcome
Number of patients with toxicity as a measure of safety and tolerability
Time frame: at an expected average of 4 weeks after the first dose of each chemotherapy course
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 8 Jul 2011.
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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.
Concetta Micalizzi, MD principal investigator
G. Gaslini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clofarabine VP 16 ciclophospahamide in people with Acute Leukemia, run by Istituto Giannina Gaslini at 1 site in Italy.
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 9 inclusion and 1 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 8 Jul 2011. 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 Italy. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
response to treatment (time frame: after an expected average of 3 weeks after the first dose of each chemotherapy course). 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 8 Jul 2011.