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Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia

NCT02224872 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-03-10

Study results available
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Summary

Our primary objective is to determine if it is feasible for SAA patients to be transplanted using non-myeloablative conditioning and post transplantation cyclophosphamide with partially HLA-mismatched donors.

Conditions

  • Severe Aplastic Anemia
  • Bone Marrow Failure Syndromes

Interventions

PROCEDURE

Bone marrow transplant

Day 0

DRUG

Thymoglobulin

0.5 mg/kg IV on Day -9 2 mg/kg IV on Days -8, -7

DRUG

Fludarabine

30 mg/M2 IV on days -6 to -2

DRUG

Cyclophosphamide

14.5 mg/kg IV on days -6, -5, 3, 4

RADIATION

TBI

200 cGy on day -1

DRUG

Mesna

40 mg/kg IV on days 3, 4

DRUG

Tacrolimus

For patients 18 years or older, tacrolimus will be given per institutional standards; may be increased or later changed to a PO BID schedule. Treatment to continue until Day 365 or longer if GVHD present

DRUG

Mycophenolic acid mofetil

15 mg/kg PO/IV TID beginning on day 5 through day 35

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Amy DeZern, MD · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
73 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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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 NCT02224872 on ClinicalTrials.gov