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Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT

NCT01012492 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-11-21

Study results available
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Summary

The primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.

Conditions

  • Biphenotypic Leukemia
  • Refractory Anemia
  • Refractory Anemia With Ringed Sideroblasts
  • AML
  • ALL
  • Undifferentiated Leukemia
  • Refractory Cytopenia With Multilineage Dysplasia
  • Ref. Cytopenia w Multilineage Dysplasia & Ringed Sideroblasts
  • Refractory Anemia With Excess Blasts-1 (5-10% Blasts)
  • Refractory Anemia With Excess Blasts-2 (10-20% Blasts)
  • Myelodysplastic Syndrome, Unclassified
  • MDS Associated With Isolated Del (5q)

Interventions

DRUG

Abatacept

Participants will receive one of two standard myeloablative conditioning regimens for their stem cell transplant, and will receive an aGvHD prophylaxis regimen including cyclosporine, methotrexate, and abatacept.

Sponsors & Collaborators

Principal Investigators

  • Leslie Kean, MD, PhD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01012492 on ClinicalTrials.gov