Acute Lymphoblastic LeukemiaPhase 1/2GRASPALLNCT00723346
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
A Phase 1/2 study testing GRASPA and native L asparaginase in people with Acute Lymphoblastic Leukemia, run by ERYtech Pharma at 1 site in France.
Trial summary
Primary objective : To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l) Secondary objective : Pharmacokinetic / Pharmacodynamic parameters toxicity Study duration : 2 years Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase… Read more about this study
- Who is it for?
- Ages 1 year to 55 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- GRASPA and native L asparaginase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Mar 2009
- Phase
- Phase 1/2
- 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 1 year to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject between 1 and 55 year old
- Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)
- Or patient who still refractory to first line chemotherapy for an ALL
- Patient who gave written informed consent (2 parents for children)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Primary objective :
- To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l)
Secondary objective :
- Pharmacokinetic / Pharmacodynamic parameters
- toxicity
- Study duration : 2 years
- Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase
- Associated treatments : COPRALL chemotherapy
- Randomization : centralised randomisation on scratching list
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- GRASPA, native L asparaginase
- Keywords
- Relapse, Lymphoma lymphoblastic
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRASPABiological
50 UI/Kg
GRASPABiological
100 UI/Kg
GRASPABiological
150 UI/Kg
native L asparaginaseDrug
10000UI/m2, 14 infusions during 4 chemotherapy cycle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: GRASPA |
| 2 | Experimental | Not described Receives: Biological: GRASPA |
| 3 | Experimental | Not described Receives: Biological: GRASPA |
| 4 | Active comparator | Not described Receives: Drug: native L asparaginase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of plasmatic asparagin depletion (< 2µmol/l)
Measured: PK points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJan 2006
- Primary completionAug 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ERYtech Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Leon Berard
- Responsible party
- Sponsor
- Investigators
- Yves Bertrand, MD PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723346
- Sponsor's protocol ID
- GRASPALL 2005-01
- Acronym
- GRASPALL
- Status last verified
- Jan 2012
- First submitted
- 24 Jul 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
- ClinicalTrials.gov ID
- NCT00723346
- Acronym / sponsor ID
- GRASPALL / GRASPALL 2005-01
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Relapse, Lymphoma lymphoblastic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ERYtech PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Centre Leon Berard
- Study start
- Jan 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 28 Jul 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.
Primary objective :
- To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l)
Secondary objective :
- Pharmacokinetic / Pharmacodynamic parameters
- toxicity
- Study duration : 2 years
- Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase
- Associated treatments : COPRALL chemotherapy
- Randomization : centralised randomisation on scratching list
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: GRASPA |
| 2 | Experimental | Biological: GRASPA |
| 3 | Experimental | Biological: GRASPA |
| 4 | Active comparator | Drug: native L asparaginase |
Who may qualify
- Ages
- 1 year to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subject between 1 and 55 year old
- Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)
- Or patient who still refractory to first line chemotherapy for an ALL
- Patient who gave written informed consent (2 parents for children)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GRASPA50 UI/Kg | Biological | 1 |
| GRASPA100 UI/Kg | Biological | 2 |
| GRASPA150 UI/Kg | Biological | 3 |
| native L asparaginase10000UI/m2, 14 infusions during 4 chemotherapy cycle | Drug | 4 |
Primary outcome
Duration of plasmatic asparagin depletion (< 2µmol/l)
Time frame: PK points
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 11 Jan 2012.
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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.
Yves Bertrand, MD PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GRASPA and native L asparaginase in people with Acute Lymphoblastic Leukemia, run by ERYtech Pharma 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 4 inclusion and 0 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 11 Jan 2012. 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 combined 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.
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?
Duration of plasmatic asparagin depletion (< 2µmol/l) (time frame: PK points). 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 11 Jan 2012.