Cerebral Lymphoma B Cell RefractoryPhase 2MYLYNCT01848652
Phase II Study Evaluating a Combination of Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy With High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
A Phase 2 study testing infusion of MYOCET in people with Cerebral Lymphoma B Cell Refractory, run by University Hospital, Brest at 3 sites in France.
Trial summary
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Lymphoma B Cell Refractory
- What is being tested?
- infusion of MYOCET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2013to May 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an indication against these treatments.
- Refractory disease is defined by the absence of objective response to treatment or relapse within 3 months of it. A relapse is defined as disease progression after obtaining a complete or partial response.
- Age greater than or equal to 18 years
- Performance Index less than 4
- Illness measured by CT or MRI
- Hematologic adequate: neutrophils> 1.5 x 106 / L, platelets> 100x106 / L
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- Adequate hepatic function: ALT / AST and bilirubin less than the upper limit of the normal laboratory
- Adequate renal function: creatinine clearance greater than 60 ml / min
- adequate cardiac function measured by ejection fraction of the left ventricle> 50% by echocardiography
- Informed consent signed
- Negative pregnancy test for women of childbearing age
- Able to understand the arrangements for monitoring the study and to comply
- Corticosteroids are only accepted during the first cycle
Who cannot join
- Patients with immunosuppression from any cause (HIV, history of transplantation, immunosuppressive treatments ...)
- Prior treatment MYOCET ® or other anthracycline
- Active infection
- Surgery large (more than 3 days hospitalization) within 28 days before enrollment in the study, except for a diagnostic neurosurgical
- Hypersensitivity to any component of the treatment
- Contraindications to the administration of MYOCET ® and / or dexamethasone Participation in a clinical trial within 4 weeks prior to study entry
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHRU de Brest
Brest, 29609
Hôpital Pitié Salpêtrière
Paris, 75651
CHU de Rennes Hôpital Pontchaillou
Rennes, 35033
About this study
Official title: Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.
This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.
- Conditions
- Cerebral Lymphoma B Cell Refractory
- Being tested
- infusion of MYOCET
- Keywords
- cerebral lymphoma B cell refractory, Myocet, efficacy, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusion of MYOCETDrug
| Study group | Role | What they receive |
|---|---|---|
| MYOCET | Experimental | Not described Receives: Drug: infusion of MYOCET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Answer at treatment
Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®).
Measured: after 2 cycles of treatment (84 days)
Secondary outcomes (1)
Tolerance at treatment
Tolerance, assessed according to the criteria of the National Cancer Institute (NCI)-Common Toxicity Criteria (CTC) version (version 4.03) after administration of each cycle, overall survival, progression-free and disease-free event for complete responses.
Measured: after each cycle and until the end of follow
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Lymphoma B Cell RefractoryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Adrian TEMPESCUL, Dr, Principal investigator, University hospital of Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848652
- Sponsor's protocol ID
- RB 12.032 - MYLY
- Acronym
- MYLY
- Status last verified
- Jul 2015
- First submitted
- 3 May 2013
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Combination Pegylated Liposomal Doxorubicin and Dexamethasone for the Treatment of Immunocompetent Patients With Cerebral Lymphoma Relapsed or Refractory to First-line Chemotherapy Containing High Dose Methotrexate (MTXHD) and / or High-dose Cytarabine.
- ClinicalTrials.gov ID
- NCT01848652
- Acronym / sponsor ID
- MYLY / RB 12.032 - MYLY
- Conditions
- Cerebral Lymphoma B Cell Refractory
- Keywords
- cerebral lymphoma B cell refractory, Myocet, efficacy, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 May 2013 (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.
The protocol is to assess the overall response rate (complete response and partial response) of treatment with non-pegylated liposomal doxorubicin at a dose of 50 mg / m² in combination with dexamethasone in immunocompetent adult patients with primary brain lymphoma large B-cell refractory or relapsed after first-line treatment MTXHD and high-dose cytarabine, excluding strict eye lymphomas.
This is a Phase II, open, prospective, multicenter, non-comparative with direct individual benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MYOCET | Experimental | Drug: infusion of MYOCET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient with cerebral lymphoma B cell refractory or relapsed within 12 months after first-line chemotherapy with high-dose methotrexate (1.5 g / m²) and high dose cytarabine (2g / m²) and / or radiotherapy or autologous, or patient with an indication against these treatments.
- Refractory disease is defined by the absence of objective response to treatment or relapse within 3 months of it. A relapse is defined as disease progression after obtaining a complete or partial response.
- Age greater than or equal to 18 years
- Performance Index less than 4
- Illness measured by CT or MRI
Key exclusion criteria (6 listed)
- Patients with immunosuppression from any cause (HIV, history of transplantation, immunosuppressive treatments ...)
- Prior treatment MYOCET ® or other anthracycline
- Active infection
- Surgery large (more than 3 days hospitalization) within 28 days before enrollment in the study, except for a diagnostic neurosurgical
- Hypersensitivity to any component of the treatment
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 |
|---|---|---|
| infusion of MYOCET | Drug | MYOCET |
Primary outcome
Answer at treatment
Time frame: after 2 cycles of treatment (84 days)
Answer, whether complete or partial, according to the International Primary CNS Lymphoma Collaborative Group (IPCG) (ASH 2004) after two cycles of treatment (4 infusions MYOCET ®).
1 secondary outcome
Tolerance at treatment
Time frame: after each cycle and until the end of follow
Results and safety
The study was stopped early (reason given: The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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.
Adrian TEMPESCUL, Dr principal investigator
University hospital of Brest
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing infusion of MYOCET in people with Cerebral Lymphoma B Cell Refractory, run by University Hospital, Brest at 3 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 13 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 was stopped early (reason given: The laboratory's partner on this study decides to terminate the contract with the CHRU Brest, because of the difficulty of the recruitment.). 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.
What does the primary outcome measure?
Answer at treatment (time frame: after 2 cycles of treatment (84 days)). 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 14 Jul 2015.