Relapsed/Refractory LeukemiaPhase 2NCT00724360
Trastuzumab for HER2 Positive Relapsed/Refractory B-Acute Lymphoblastic Leukemia (B-ALL)
A Phase 2 study testing Herceptin (trastuzumab) in people with Relapsed/Refractory Leukemia, run by Nantes University Hospital at 8 sites in France.
Trial summary
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Leukemia
- What is being tested?
- Herceptin (trastuzumab)
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 8 sitesFrance
- Study dates
- Nov 2006to Nov 2011
- 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
- age > 18 years
- B-ALL in relapse
- refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
- adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal creatinine < 2 times the upper limit of normal)
- > 20% blasts in bone marrow,
- > 30% of bone marrow blast population HER2 positive as assessed by immunophenotyping
Who cannot join
- Previous treatment by trastuzumab
- FEVG < 50%
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003
Mondor Hospital
Créteil, 94000
Grenoble Hospital
Grenoble, 38043
Institut Paoli Calmettes
Marseille, 13273
CHU
Nantes, 44093
St Louis Hospital
Paris, 75010
Rennes University Hospital
Rennes, 35033
Strasbourg University Hospital
Strasbourg, 67098
About this study
Official title: A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.
- Conditions
- Relapsed/Refractory Leukemia
- Being tested
- Herceptin (trastuzumab)
- Keywords
- relapsed/refractory, HER2, positive, B-ALL, trastuzumab
- Medical subject headings
- Leukemia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herceptin (trastuzumab)Drug
Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
Secondary outcomes (5)
Trastuzumab efficiency concerning transfusional needs
Overall survival
Leukemia free survival
cytogenetic response rate
Trastuzumab tolerance profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startNov 2006
- Primary completionJul 2011
- Study completionNov 2011
Why it stopped: Difficulties of recruitment
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 Relapsed/Refractory LeukemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724360
- Sponsor's protocol ID
- BRD04/2-T
- Status last verified
- Oct 2013
- First submitted
- 25 Jul 2008
- Last updated
- 7 Oct 2013
- Results posted
- No
Publications
Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.
PubMed 22267607
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating the Safety and the Efficacy of Trastuzumab in Relapsed/Refractory HER2 Positive B-acute Lymphoblastic Leukemia Patients.
- ClinicalTrials.gov ID
- NCT00724360
- Acronym / sponsor ID
- BRD04/2-T
- Conditions
- Relapsed/Refractory Leukemia
- Keywords
- relapsed/refractory, HER2, positive, B-ALL, trastuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 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.
This is a multicenter open-label phase II trial of trastuzumab in patients with HER2 positive B-ALL in relapse, or with refractory disease. Herceptin is administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or till progression. Response and HER2 expression are assessed each month by bone marrow aspirate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age > 18 years
- B-ALL in relapse
- refractory B-ALL-performance status of 0-2 on the Eastern Cooperative Oncology Group scale
- adequate hepatic and renal functions (AST or ALT <= 5 times the upper limit of normal creatinine < 2 times the upper limit of normal)
- > 20% blasts in bone marrow,
Key exclusion criteria (2 listed)
- Previous treatment by trastuzumab
- FEVG < 50%
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 |
|---|---|---|
| Herceptin (trastuzumab)Administered as a 4 mg/kg intravenous loading dose followed by 2 mg/kg weekly for at least 2 months and/or until progression | Drug | – |
Primary outcome
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR)
5 secondary outcomes
Trastuzumab efficiency concerning transfusional needs
Overall survival
Leukemia free survival
cytogenetic response rate
Trastuzumab tolerance profile
Results and safety
The study was stopped early (reason given: Difficulties of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
- Derived from this study: PubMed 22267607Chevallier P, Robillard N, Charbonnier A, Raffoux E, Maury S, Carras S, Chabrot C, Fohrer C, Bernard M, Blade JS, Etienne A, Talmant P, Delaunay J, Guillaume T, Mohty M, Bene MC, Ifrah N, Dombret H. Trastuzumab for treatment of refractory/relapsed HER2-positive adult B-ALL: results of a phase 2 GRAALL study. Blood. 2012 Mar 15;119(11):2474-7. doi: 10.1182/blood-2011-11-390781. Epub 2012 Jan 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 Herceptin (trastuzumab) in people with Relapsed/Refractory Leukemia, run by Nantes University Hospital at 8 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 6 inclusion and 2 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 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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: Difficulties of 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?
Response rate: Response was defined either as complete response (CR), CR without recovery of platelet (CRp), or partial response (PR). 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 NCT00724360, 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 7 Oct 2013.