Acute Lymphoblastic LeukemiaEAPNCT02197650
Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
A study testing suspension of erythrocytes encapsulating L-asparaginase in people with Acute Lymphoblastic Leukemia, run by ERYtech Pharma at 10 sites in France.
Trial summary
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase. Read more about this study
- Who is it for?
- Ages Up to 55 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- suspension of erythrocytes encapsulating L-asparaginase
- How many people
- Not given
- Where
- 10 sitesFrance
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Up to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with ALL de novo or in relapse or refractory
- Eligible to a chemotherapy treatment including L-asparaginase
- Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available
- Patient under 55 years old
- Patient informed and consent provided (the 2 parents need to consent for children).
Who cannot join
- Patient unable to receive GRASPA due to general or visceral conditions
- Serum creatinine ≥ 2 x ULN unless related to ALL
- ALT or AST ≥ 3 x ULN unless related to ALL
- Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN
- Other serious conditions according to investigator's opinion.
- Absence of documented serological test for HIV, B and C hepatitis
Show all 13Show fewer
- History of grade 3 transfusional incident or any contraindication to receive blood transfusion
- Patient under concomitant treatment likely to cause hemolysis
- Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
- Patient undergoing yellow fever vaccination.
- Patient under phenytoin treatment.
- Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- Patient already included in another clinical trial
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital Jean Minjoz - Batiment MEMCP
Besançon, 25030
CHRU Lille - Hôpital Claude-Huriez
Lille, 59037
IHOP
Lyon, 69373
Hôpital de l'Archet 2
Nice, 06202
Hôpital Saint Louis
Paris, 75475
CHU Rouen - Hôpital des enfants
Rouen, 76031
CHU Saint Etienne Hôpital Nord
Saint-Etienne, 42055
Institut Universitaire du Cancer
Toulouse, 31100
Hôpital BRETONNEAU
Tours, 37044
Hôpital Brabois Enfants
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Read the detailed description
Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- suspension of erythrocytes encapsulating L-asparaginase
- Keywords
- ALL L-asparaginase encapsulated erythrocytes
- 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.
suspension of erythrocytes encapsulating L-asparaginaseDrug
Also called GRASPA®, eryaspase
Erythrocytes encapsulating L-asparaginase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ERYtech Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pr. Yves BERTRAND, Principal investigator, IHOP, LyonPr. Hervé DOMBRET, Principal investigator, Hôpital Saint Louis Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197650
- Sponsor's protocol ID
- GRASPALL 2012-10-EAP
- Acronym
- EAP
- Status last verified
- Nov 2018
- First submitted
- 7 May 2014
- Last updated
- 4 Dec 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
- ClinicalTrials.gov ID
- NCT02197650
- Acronym / sponsor ID
- EAP / GRASPALL 2012-10-EAP
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- ALL L-asparaginase encapsulated erythrocytes
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- ERYtech PharmaIndustry (pharma, biotech, devices)
- First posted
- 23 Jul 2014 (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.
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Detailed description
Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an "Expended Access Program" framework.
Study design
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with ALL de novo or in relapse or refractory
- Eligible to a chemotherapy treatment including L-asparaginase
- Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available
- Patient under 55 years old
- Patient informed and consent provided (the 2 parents need to consent for children).
Key exclusion criteria (13 listed)
- Patient unable to receive GRASPA due to general or visceral conditions
- Absence of documented serological test for HIV, B and C hepatitis
- History of grade 3 transfusional incident or any contraindication to receive blood transfusion
- Patient under concomitant treatment likely to cause hemolysis
- Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
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 |
|---|---|---|
| suspension of erythrocytes encapsulating L-asparaginaseAlso: GRASPA®, eryaspaseErythrocytes encapsulating L-asparaginase | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Pr. Yves BERTRAND principal investigator
IHOP, Lyon
Pr. Hervé DOMBRET principal investigator
Hôpital Saint Louis Paris
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suspension of erythrocytes encapsulating L-asparaginase in people with Acute Lymphoblastic Leukemia, run by ERYtech Pharma at 10 sites 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
Are results available for this study?
Results are not available in the source record.
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.
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 4 Dec 2018.