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NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia

NCT02833805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-07-12

Study results available
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Summary

Our primary objective is to determine if it is feasible for previously untreated severe aplastic anemia (SAA) patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide.

Conditions

  • Severe Aplastic Anemia
  • Aplastic Anemia
  • Bone Marrow Failure
  • Immunosuppression

Interventions

DRUG

Thymoglobulin

Day -9: 0.5 mg/kg Days -8 and -7: 2 mg/kg daily

DRUG

Fludarabine

Days -6 through -2: 30 mg/m\^2 IV daily

DRUG

Cyclophosphamide

Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily

RADIATION

Total body irradiation

Day -1: 200 centigray (cGy) in a single fraction

DRUG

Tacrolimus

Start on Day 5 through Day 365

DRUG

Mycophenolate mofetil

Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Amy E DeZern, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02833805 on ClinicalTrials.gov