Actively Recruiting

Phase 2
Age: 1Year - 50Years
All Genders
NCT01804634

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-13

60

Participants Needed

3

Research Sites

874 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to see if giving reduced intensity chemotherapy, haploidentical bone marrow, post-transplant cyclophosphamide and shortened duration tacrolimus is safe and feasible for patients with very high-risk solid tumors.

CONDITIONS

Official Title

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Who Can Participate

Age: 1Year - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of a suitable related HLA-haploidentical bone marrow donor matching at least 5 of 10 alleles
  • Age between 1 year and 50 years
  • Confirmed high-risk solid tumor with expected survival less than 10%, including neuroblastoma, rhabdomyosarcoma, metastatic Ewing sarcoma, osteosarcoma with advanced metastases, desmoplastic small round cell tumor, or other similar tumors
  • Prior standard therapy received; patients relapsing after autologous bone marrow transplant eligible if over 6 months have passed since last transplant
  • Recovery from acute toxicities of prior treatments
  • Stable disease if measurable, confirmed by scans at least 6 weeks apart
  • Adequate organ function: heart ejection fraction ≥35% or shortening fraction >25%, bilirubin ≤3.0 mg/dL, liver enzymes less than 5 times upper limit, renal function normal or creatinine clearance >40 mL/min/1.73m2, lung function with FEV1, FVC, and DLCO >50% predicted or oxygen saturation >92% on room air
  • Good performance status (Karnofsky or Lansky score 60-100)
  • Ability of patient or guardian and donor to sign consent forms
  • Willingness to participate in all treatment stages
Not Eligible

You will not qualify if you...

  • HIV positive status
  • Donor-recipient ABO incompatibility if a compatible donor is available
  • Positive leukocytotoxic crossmatch
  • Women who are pregnant or not using adequate contraception
  • Uncontrolled infections including viral, bacterial, or fungal
  • Donor under 0.5 years old
  • Presence of recipient anti-donor HLA antibodies at levels not approved by the study team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231

Actively Recruiting

2

Albert Einstein College of Medicine, Children's Hospital at Montefiore

The Bronx, New York, United States, 10467

Actively Recruiting

3

New York Medical Center/ Maria Fareri Children's Hospital

Valhalla, New York, United States, 10595

Actively Recruiting

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Research Team

H

Heather Symons, MD, MHS

CONTACT

J

Jasmine Brooks, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Reduced Intensity Haploidentical BMT for High Risk Solid Tumors | DecenTrialz