Acute Lymphoblastic LeukemiaPhase 2NCT00600977
Liposomal Anthracyclin in the Treatment of Elderly ALL
A Phase 2 study testing Doxorubicine and Doxorubicine pegylated in people with Acute Lymphoblastic Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Doxorubicine and Doxorubicine pegylated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2002to Oct 2006
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age and older
- ECOG performance </=2 or >/=3
- VIH negative
- Absence of previous ALL treatment
- Informed consent signed
- SGPT and Bilirubin < 4x upper limit of normal
- Normal creatinine for age
- cardiac state compatible with anthacyclin
Who cannot join
- ALL with Philadelphia Chromosome
- ALL3
- CML blasts crisis
- Cardiac insufficiency and/ or left ventricular ejection fraction < 50%
- Evolutive infection
- Presence of other evolutifs cancer or ongoing treatment
- mental status incompatible with inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients
Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone
Read the detailed description
Patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be treated according to the another French Protocol while patients with Ph-ve ALL will be included in the "caelyx" protocol and randomly allocated to induction with VAD or with vadox-li-Peg (caelyx).
A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients.
Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine.
During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients.
Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Doxorubicine, Doxorubicine pegylated
- Keywords
- ALL, Chemotherapy, Pharmacokinetics of doxorubicin (pegylated or not), elderly ALL
- 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.
DoxorubicineDrug
9mg/m² J1 J4 2 COURSES
Doxorubicine pegylatedDrug
40 MG/M² J1 2 courses
| Study group | Role | What they receive |
|---|---|---|
| doxorubicine | Active comparator | VAD Receives: Drug: Doxorubicine |
| Doxorubicine pegylated | Experimental | Doxorubicine pegylated 40 MG/M² J1 Receives: Drug: Doxorubicine pegylated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
Measured: 113 days
Secondary outcomes (5)
Hematological and cutaneous adverse evnts of both types of chemotherapy
Measured: 113 days
Resistance to chemotherapy
Measured: 113 days
Complete response rates
Measured: 113 days
Disease free and overall survival
Measured: 4 months
Economical study
Measured: 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startMar 2002
- Study completionOct 2006
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 Lymphoblastic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Investigators
- Mathilde HUNAULT BERGER, RN, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600977
- Sponsor's protocol ID
- GOELAL LALA SA1
- Other IDs
- U01-AA1234-01
- Status last verified
- Jun 2008
- First submitted
- 26 Sep 2007
- Last updated
- 26 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hunault-Berger M, Leguay T, Thomas X, Legrand O, Huguet F, Bonmati C, Escoffre-Barbe M, Legros L, Turlure P, Chevallier P, Larosa F, Garban F, Reman O, Rousselot P, Dhedin N, Delannoy A, Lafage-Pochitaloff M, Bene MC, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). A randomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia: the GRAALL-SA1 study. Haematologica. 2011 Feb;96(2):245-52. doi: 10.3324/haematol.2010.027862. Epub 2010 Oct 22.
PubMed 20971822
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric Phase II-III Randomized Study Safety of Intraveinous Liposomal Pegylated Doxorubicin Versus Continuous Infusion of Doxorubicin During Induction Treatment of Acute Lymphoblastic Leukemia in Patients
- ClinicalTrials.gov ID
- NCT00600977
- Acronym / sponsor ID
- GOELAL LALA SA1
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL, Chemotherapy, Pharmacokinetics of doxorubicin (pegylated or not), elderly ALL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Mar 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 25 Jan 2008 (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.
Phase II multicentric study comparing VAD regimen with continuous infusion over 96 hours of doxorubicin, vincristine and dexamethasone to a 90 minutes infusion of equivalent doses of Dox li-PEG, bolus infusion of vincristine and dexamethasone
Detailed description
Patients aged 55 years or over will be assessed for response to steroids from day -7 to day 0 During steroid therapy, Ph status will be determinated : patients with Ph+ ve ALL will be treated according to the another French Protocol while patients with Ph-ve ALL will be included in the "caelyx" protocol and randomly allocated to induction with VAD or with vadox-li-Peg (caelyx).
A second course of induction therapy with VAD+ cyclophosphamide of Vadox-li-peg+ cyclophosphamide(according to the initial randomization arm) will then be given to all patients.
Consolidation therapy included 2 courses of vad or of vadox-li-Peg , according to the initial random allocation, followed by two courses of cytarabine,cyclophosphamide and thioguanine.
During induction and consolidation therapy, doxorubicin and liposomal pegylated doxorubicin pharmacokinetics will be assessed in all patients.
Treatment of occult CNS invasion includes skull radiotherapy and 6 intrathecal injections(steroÏds+methotrexate) A two years maintenance course with 6 mercaptopurine and methotrexate will then be offered to all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxorubicine | Active comparator | Drug: DoxorubicineVAD |
| Doxorubicine pegylated | Experimental | Drug: Doxorubicine pegylatedDoxorubicine pegylated 40 MG/M² J1 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 55 years of age and older
- ECOG performance </=2 or >/=3
- VIH negative
- Absence of previous ALL treatment
- Informed consent signed
Key exclusion criteria (7 listed)
- ALL with Philadelphia Chromosome
- ALL3
- CML blasts crisis
- Cardiac insufficiency and/ or left ventricular ejection fraction < 50%
- Evolutive infection
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 |
|---|---|---|
| Doxorubicine9mg/m² J1 J4 2 COURSES | Drug | doxorubicine |
| Doxorubicine pegylated40 MG/M² J1 2 courses | Drug | Doxorubicine pegylated |
Primary outcome
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy
Time frame: 113 days
5 secondary outcomes
Hematological and cutaneous adverse evnts of both types of chemotherapy
Time frame: 113 days
Resistance to chemotherapy
Time frame: 113 days
Complete response rates
Time frame: 113 days
Disease free and overall survival
Time frame: 4 months
Economical study
Time frame: 113 days
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 26 Jun 2008.
- Derived from this study: PubMed 20971822Hunault-Berger M, Leguay T, Thomas X, Legrand O, Huguet F, Bonmati C, Escoffre-Barbe M, Legros L, Turlure P, Chevallier P, Larosa F, Garban F, Reman O, Rousselot P, Dhedin N, Delannoy A, Lafage-Pochitaloff M, Bene MC, Ifrah N, Dombret H; Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL). A randomized study of pegylated liposomal doxorubicin versus continuous-infusion doxorubicin in elderly patients with acute lymphoblastic leukemia: the GRAALL-SA1 study. Haematologica. 2011 Feb;96(2):245-52. doi: 10.3324/haematol.2010.027862. Epub 2010 Oct 22.
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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.
Mathilde HUNAULT BERGER, RN principal investigator
French Innovative Leukemia Organisation
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 Doxorubicine and Doxorubicine pegylated in people with Acute Lymphoblastic Leukemia, run by French Innovative Leukemia Organisation at 1 site in France.
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 8 inclusion and 7 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 26 Jun 2008. 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 France. 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?
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?
Number of patients alive by day 113 ( last injection of anthracycline ) and having received a full course of induction/consolidation therapy (time frame: 113 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00600977, 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 26 Jun 2008.