Hematopoietic Stem Cell TransplantPhase 2ALTERGREFNCT03250546
Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
A Phase 2 study testing transplant from a haplo-identical donor and transplant from a non related donor in people with Hematopoietic Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte… Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- transplant from a haplo-identical donor and transplant from a non related donor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2017to 30 Nov 2022
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
- Without HLA matched related or unrelated donor
- Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
- Having read and understood the information letter and signed the informed consent
- With health insurance coverage
Who cannot join
- Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
- Performance Scale by the Eastern Cooperative Oncology Group (ECOG)> 2
- Severe uncontrolled infection
- Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction <50%)
- Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 N, creatinine > 150 mmol/L (except if related to malignancy)
- Previous active cancer in the last two years, except basal cell skin cancer and in situ carcinoma of the cervix
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- Childbearing age woman refusing contraception
- Patients who did not accept the follow-up planned by the protocol
- Positive serology for HIV or Human T-Lymphotropic Virus (HTLV)-1, 2, or active viral infection by the Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
- Pregnant woman (positive β-HCG) or during lactation
- Adult patient on guardianship, or safeguard justice
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Saint Louis hospital
Paris, 75010
Nathalie DHEDIN, MD, 33+142385127, nathalie.dhedin@aphp.fr
Nathalie Dhedin, MD
- Recruiting
Service Hématologie Clinique
Paris, 75013
Stéphanie NGUYEN, MD PhD, 33+142162823, stephanie.nguyen-quoc@aphp.fr
About this study
Official title: Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).
It will use a Phase II, multicenter, prospective, randomized clinical trial.
By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- transplant from a haplo-identical donor, transplant from a non related donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transplant from a haplo-identical donorProcedure or surgery
The transplant procedures will be similar in the 2 groups beside the origin of cells
transplant from a non related donorProcedure or surgery
The transplant procedures will be similar in the 2 groups beside the origin of cells
| Study group | Role | What they receive |
|---|---|---|
| Haplo-identical group | Experimental | Not described Receives: Procedure: transplant from a haplo-identical donor |
| HLA-9/10 MMUD group | Active comparator | Not described Receives: Procedure: transplant from a non related donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
Measured: 2 year
Secondary outcomes (1)
100 day engraftment
Measured: day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start20 Nov 2017
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective Phase II Clinical Trial
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250546
- Sponsor's protocol ID
- P151001
- Acronym
- ALTERGREF
- Status last verified
- Feb 2019
- First submitted
- 31 Jul 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Phase II Clinical Trial Using Post-Transplantation Cyclophosphamide for Prevention of GVHD in Haploidentical and HLA-9/10 Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03250546
- Acronym / sponsor ID
- ALTERGREF / P151001
- Conditions
- Hematopoietic Stem Cell Transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 15 Aug 2017 (actual)
- 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 primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).
It will use a Phase II, multicenter, prospective, randomized clinical trial.
By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized prospective Phase II Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Haplo-identical group | Experimental | Procedure: transplant from a haplo-identical donor |
| HLA-9/10 MMUD group | Active comparator | Procedure: transplant from a non related donor |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
- Without HLA matched related or unrelated donor
- Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
- Having read and understood the information letter and signed the informed consent
- With health insurance coverage
Key exclusion criteria (11 listed)
- Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
- Performance Scale by the Eastern Cooperative Oncology Group (ECOG)> 2
- Severe uncontrolled infection
- Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction <50%)
- Aspartate transaminase (AST) and alanine transaminase (ALT) > 2.5 N, creatinine > 150 mmol/L (except if related to malignancy)
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 |
|---|---|---|
| transplant from a haplo-identical donorThe transplant procedures will be similar in the 2 groups beside the origin of cells | Procedure or surgery | Haplo-identical group |
| transplant from a non related donorThe transplant procedures will be similar in the 2 groups beside the origin of cells | Procedure or surgery | HLA-9/10 MMUD group |
Primary outcome
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD
Time frame: 2 year
1 secondary outcome
100 day engraftment
Time frame: day 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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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.
2 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 transplant from a haplo-identical donor and transplant from a non related donor in people with Hematopoietic Stem Cell Transplant, run by Assistance Publique - Hôpitaux de Paris at 2 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 11 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 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year progression free survival, without acute GVHD grade III-IV and without moderate/severe cGVHD (time frame: 2 year). 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 19 Feb 2019.