LeukemiaNCT02981784
Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I
An observational study of Leukemia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Ponatinib (Iclusig®) and allogeneic stem cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2000to Dec 2015
- Phase
- Observational
- 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
Study population: All 128 T315I+ patients from PACE comprised the ponatinib group of this study. Fifty-six patients from the EBMT database comprised the allo-SCT group
Who may be able to join
- CML any phase with T315I mutation
- Ph+ ALL with a T315I mutation
- Being treated in the PACE trial according to the criteria of this phase II trial
- Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.
Who cannot join
- Ph negative patients
- Patients under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).
- Conditions
- Leukemia
- Being tested
- Ponatinib (Iclusig®), allogeneic stem cell transplantation
- Keywords
- chronic myeloid leukemia (CML), Philadelphia-positive (Ph+), Acute Lymphoblastic Leukemia (ALL)
- Medical subject headings
- Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ponatinib (Iclusig®)Drug
Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.
allogeneic stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Ponatinib (PACE trial) | PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440 Receives: Drug: Ponatinib (Iclusig®) | |
| Allogenis stem cell transplantation (EBMT registry) | EBMT : European Group for Blood and Marrow Transplantation Receives: Procedure: allogeneic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
Measured: From date of inclusion until the date of death, assessed up to 180 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2000
- Primary completionDec 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981784
- Sponsor's protocol ID
- 69HCL16_0716
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Survival With Ponatinib Versus Allogeneic Stem Cell Transplant in Philadelphia-positive Leukemias With the T315I Mutation
- ClinicalTrials.gov ID
- NCT02981784
- Acronym / sponsor ID
- 69HCL16_0716
- Conditions
- Leukemia
- Keywords
- chronic myeloid leukemia (CML), Philadelphia-positive (Ph+), Acute Lymphoblastic Leukemia (ALL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Dec 2016 (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.
Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ponatinib (PACE trial) | – | Drug: Ponatinib (Iclusig®)PACE trial : "Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)", NCT01207440 |
| Allogenis stem cell transplantation (EBMT registry) | – | Procedure: allogeneic stem cell transplantationEBMT : European Group for Blood and Marrow Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All 128 T315I+ patients from PACE comprised the ponatinib group of this study. Fifty-six patients from the EBMT database comprised the allo-SCT group
Key inclusion criteria (4 listed)
- CML any phase with T315I mutation
- Ph+ ALL with a T315I mutation
- Being treated in the PACE trial according to the criteria of this phase II trial
- Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen.
Key exclusion criteria (2 listed)
- Ph negative patients
- Patients under 18 years
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 |
|---|---|---|
| Ponatinib (Iclusig®)Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation. | Drug | Ponatinib (PACE trial) |
| allogeneic stem cell transplantation | Procedure or surgery | Allogenis stem cell transplantation (EBMT registry) |
Primary outcome
Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)
Time frame: From date of inclusion until the date of death, assessed up to 180 months
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 5 Dec 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Hospices Civils de Lyon 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 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: finished, as of the sponsor's last update on 5 Dec 2016. 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.
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?
Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months) (time frame: From date of inclusion until the date of death, assessed up to 180 months). 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 5 Dec 2016.