Acute Lymphocytic LeukemiaPhase 1/2CampathNCT00773149
Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia
A Phase 1/2 study testing Alemtuzumab (CAMPATH 1H) associated to G-CSF in people with Acute Lymphocytic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- Alemtuzumab (CAMPATH 1H) associated to G-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Jul 2011
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients older than 15 years
- Refractory ALL
- ALL in relapse post chemotherapy or post transplant
- ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
- Signed informed consent
- Patients under social security coverage
- Anti conceptional tablets in pre menopausal women.
Who cannot join
- Children below 15 years of age or aged 15
- Blast cells not expressing CD52 antigen (at all evaluations)
- HIV positivity
- ECOG Score 3 and 4
- Hypersensitivity to Alemtuzumab.
- Pregnancy or breast feeding.
- Other malignant disease in addition to ALL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.
The use of G-CSF is justified by a possible increase in ADCC.
Read the detailed description
All patients receive Alemtuzumab in 3 successive phases:
Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.
- Conditions
- Acute Lymphocytic Leukemia
- Being tested
- Alemtuzumab (CAMPATH 1H) associated to G-CSF
- Keywords
- Adult Acute Lymphocytic Leukemia, Alemtuzumab
- 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.
Alemtuzumab (CAMPATH 1H) associated to G-CSFDrug
All patients receive Alemtuzumab in 3 successive phases:
Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | all included patients Receives: Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial and complete remission, overall response rates
Measured: At 2 years
Secondary outcomes (2)
Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.
Measured: At 2 years
Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2006
- Primary completionJan 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Claude GORIN, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773149
- Sponsor's protocol ID
- P051003
- Acronym
- Campath
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2008
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
- ClinicalTrials.gov ID
- NCT00773149
- Acronym / sponsor ID
- Campath / P051003
- Conditions
- Acute Lymphocytic Leukemia
- Keywords
- Adult Acute Lymphocytic Leukemia, Alemtuzumab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Oct 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.
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.
The use of G-CSF is justified by a possible increase in ADCC.
Detailed description
All patients receive Alemtuzumab in 3 successive phases:
Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Alemtuzumab (CAMPATH 1H) associated to G-CSFall included patients |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients older than 15 years
- Refractory ALL
- ALL in relapse post chemotherapy or post transplant
- ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
- Signed informed consent
Key exclusion criteria (7 listed)
- Children below 15 years of age or aged 15
- Blast cells not expressing CD52 antigen (at all evaluations)
- HIV positivity
- ECOG Score 3 and 4
- Hypersensitivity to Alemtuzumab.
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 |
|---|---|---|
| Alemtuzumab (CAMPATH 1H) associated to G-CSFAll patients receive Alemtuzumab in 3 successive phases: Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance. Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented. Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months. | Drug | 1 |
Primary outcome
Partial and complete remission, overall response rates
Time frame: At 2 years
2 secondary outcomes
Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.
Time frame: At 2 years
Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.
Time frame: at 2 years
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 Jul 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.
Norbert Claude GORIN, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Alemtuzumab (CAMPATH 1H) associated to G-CSF in people with Acute Lymphocytic Leukemia, run by Assistance Publique - Hôpitaux de Paris 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 7 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 Jul 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?
Partial and complete remission, overall response rates (time frame: At 2 years). 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 26 Jul 2012.