Acute LeukemiaPhase 3HaploMUD-RICNCT03595800
Extension of a Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen
A Phase 3 study testing Hematopoietic stem cells transplantation in people with Acute Leukemia and Non Hodgkin Lymphoma, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
- What is being tested?
- Hematopoietic stem cells transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2017to 12 Mar 2021
- Phase
- Phase 3
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with hematological malignancy
- Age<55 years
- HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
- Patients without a matched related donor
- Patients eligible for an allogeneic HSCT from an alternative donor
- Able to comply with the protocol
- Written informed consent
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Who cannot join
- Clinical or biological contraindication to allogeneic HSCT
- Pregnant or breast-feeding women.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
- Severe concomitant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.
- Conditions
- Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
- Being tested
- Hematopoietic stem cells transplantation
- Medical subject headings
- Lymphoma, Non-Hodgkin, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic stem cells transplantationProcedure or surgery
Allogeneic Hematopoietic stem cells transplantation
| Study group | Role | What they receive |
|---|---|---|
| haploidentical related donors | Experimental | Not described Receives: Procedure: Hematopoietic stem cells transplantation |
| Matched unrelated donor | Active comparator | Not described Receives: Procedure: Hematopoietic stem cells transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start19 Sep 2017
- Primary completion2 Feb 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samia Harbi, MD, Principal investigator, Institut Paoli-CalmettesDidier Blaise, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595800
- Sponsor's protocol ID
- HaploMUD-RIC-01-IPC 2017-048
- Acronym
- HaploMUD-RIC
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2018
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extension of a Phase III Randomized Study of Allogeneic Hematopoietic Stem Cell Transplantation From One Haplotype Mismatch Related Donor or From an Unrelated Donor to Younger Patients Eligible for Reduced-intensity Conditioning Regimen-HaploMUD-RIC-01
- ClinicalTrials.gov ID
- NCT03595800
- Acronym / sponsor ID
- HaploMUD-RIC / HaploMUD-RIC-01-IPC 2017-048
- Conditions
- Acute Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 23 Jul 2018 (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.
This study is an extension to younger patients of the currently ongoing national, multicenter, open-label, randomized phase III HAPLOMUDELDERLY which evaluates elderly patients with hematological malignancies, justifying an allo-HSCT from an alternative donor when a MRD has not been identified. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| haploidentical related donors | Experimental | Procedure: Hematopoietic stem cells transplantation |
| Matched unrelated donor | Active comparator | Procedure: Hematopoietic stem cells transplantation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with hematological malignancy
- Age<55 years
- HCT-CI score ≥ 3 or non-eligible for myeloablative regimen
- Patients without a matched related donor
- Patients eligible for an allogeneic HSCT from an alternative donor
Key exclusion criteria (4 listed)
- Clinical or biological contraindication to allogeneic HSCT
- Pregnant or breast-feeding women.
- Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
- Severe concomitant disease
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 |
|---|---|---|
| Hematopoietic stem cells transplantationAllogeneic Hematopoietic stem cells transplantation | Procedure or surgery | Matched unrelated donor, haploidentical related donors |
Primary outcome
Event-free survival
Time frame: 5 years
the time from randomization to the time of a first occurrence of an event with death, relapse or occurrence of severe cGVHD as event and considered as censored at the time of last follow-up visit
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 1 Oct 2026.
- 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.
Samia Harbi, MD principal investigator
Institut Paoli-Calmettes
Didier Blaise principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hematopoietic stem cells transplantation in people with Acute Leukemia and Non Hodgkin Lymphoma, run by Institut Paoli-Calmettes 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 8 inclusion and 4 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 1 Oct 2026. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Event-free survival (time frame: 5 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 1 Oct 2026.