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NCT03595800 Clinical Trial

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

Multiple Myeloma Clinical Trial

— HaploMUD-RIC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03595800
Other study ID # HaploMUD-RIC-01
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date September 19, 2017
Est. completion date February 2, 2022

Study information
Verified date March 2021
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. It will extend the investigation of these two modalities of allo-HSCT to younger patients which are eligible to RIC.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 54
Est. completion date February 2, 2022
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Hematopoietic stem cells transplantation
Allogeneic Hematopoietic stem cells transplantation

Locations
Country Name City State
France Institut Paoli-Calmettes Marseille

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 5 years
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