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
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.
- 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