Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor

NCT02500550

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

COMPLETED PHASE2

Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)

NCT00412360

Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia +2 more

COMPLETED PHASE3

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

NCT00723099

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Aggressive Non-Hodgkin Lymphoma +23 more

COMPLETED PHASE2

A Phase I/II Study of Gene-modified WT1 TCR Therapy in MDS & AML Patients

NCT02550535

Myelodysplastic Syndromes (MDS) Acute Myeloid Leukaemia (AML)

COMPLETED PHASE1/PHASE2

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

NCT00719888

Acute Biphenotypic Leukemia Acute Lymphoblastic Leukemia Acute Myeloid Leukemia +16 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HAPLO group

Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013

No interventions assigned to this group

MUD group

Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012

No interventions assigned to this group

MMUD group

Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012

No interventions assigned to this group

UCB group

Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any of the following hematologic malignancies:

* Acute myeloid leukemia (AML) in remission at the time of the transplantation
* Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
* Myelodysplastic syndrome (MDS)
* Patient received any of the following transplantations:

* Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
* Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
* Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
* Male or female, age ≥ 18, ≤ 65 years.