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Not yet recruiting NCT06286228

Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease

— Observational Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are: * 1-year progression free survival rate * 1-year overall survival rate * Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year * Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year * Rate of Neutrophil and platelet engraftment * Efficacy of donor specific antibody desensitization * Relapsed rate * Primary and late graft failure * Safety and complication of haploHSCT * Complication of viral, bacterial, and fungal infection * Viral reactivation * Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT * Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.

Primary outcome measures

  • register hematologic patients with haploidentical hematopoietic stem cell transplantation [Time frame: 5 years]
Secondary outcome measures (12)
  • progression free survival rate [Time frame: 1 year]
  • overall survival rate [Time frame: 1 year]
  • Chronic Graft-versus-host free relapsed free survival [Time frame: at 180-day and 1-year]
  • Relapsed rate [Time frame: 5 years]
  • Primary and late graft failure [Time frame: 5 years]
  • Rate of Neutrophil and platelet engraftment [Time frame: during admission]
  • Efficacy of donor specific antibody desensitization [Time frame: during admission]
  • Safety and complication of haploHSCT [Time frame: 5 years]
  • Complication of viral, bacterial, and fungal infection [Time frame: during admission]
  • Viral reactivation [Time frame: during admission]
  • outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT [Time frame: 5 years]
  • cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
  • Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
  • Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
  • severe aplastic anemia
  • Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • normal AST and ALT, creatinine \<2g/dL, and left ventricular ejection fraction ≥50%
  • age \>18 years
  • Capable of informed consent and provision of written informed consent before any study procedures
  • Capable of attending all study visits according to the study schedule
  • Female subjects who is childbearing potential must have a negative result for pregnancy test

Exclusion criteria

  • HIV infection, active hepatitis B, active hepatitis C
  • active infection
  • history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
  • A pregnant woman and/or refusal of contraception

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06286228 · 751/2563(IRB4)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗