Back to search results

Reduced Intensity Haploidentical Bone Marrow Transplant for High-Risk Solid Tumors

This study is looking at a new approach for people aged 1 to 50 with very high-risk solid tumors that have returned or spread. It combines reduced intensity chemotherapy (using cyclophosphamide, fludarabine, low dose total body irradiation, and melphalan) with a bone marrow transplant from a half-matched donor (haploidentical BMT). After the transplant, you would receive cyclophosphamide and a shorter course of tacrolimus. The main goal is to see if this treatment is safe and practical, specifically by tracking serious side effects and a condition called graft-versus-host disease (GVHD) within the first 120 days. This approach aims to use your donor's immune cells to fight the cancer. The study plans to enroll 60 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 60 participants.
What's involved
You would need a central venous catheter placed for medications and blood products. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess safety for up to 120 days after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01804634

Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Recruiting
PHASE2Ages 1–50InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~60 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabinelow dose total body irradiationMelphalanTacrolimus

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120
Measured over up to 120 Days

Conditions

Refractory and/or Relapsed Metastatic Solid Tumors

Explore related trials

Desmoplastic Small Round Cell TumorEwing SarcomaHepatoblastomaNeuroblastomaOsteosarcomaRhabdomyosarcomaSolid NeoplasmHLA Complex

Where it's being run

3 sites across 2 states
New York2
Maryland1

Study leadership

  • Heather Symons, MD, MHS · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Heather Symons, MD, MHS
[email protected]
410-502-4997
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Safety of Shortened duration of tacrolimus as assessed by number of participants with NRM and Grade III-IV acute GVHD at Day 120up to 120 Days

    Safety of shortened duration immunosuppression assessed by the number of participants with non-relapse mortality (NRM) and grade III-IV acute graft versus host disease (Przepiorka criteria stages the degree of organ involvement in the skin, liver and gastrointestinal (GI) tract, based on severity, with Stage 1+ being least sever and Stage 4+ being most severe. Grading of acute GVHD is as follows: Grade I (skin involvement stages 1+ to 2+, with no liver or GI involvement), Grade II (skin involvement stages 1+ to 3+, liver 1+, GI tract 1+), Grade III (skin involvement stages 2+ to 3+, liver 1+, GI tract 2+ to 4+), Grade IV (skin involvement stages 4+, liver 4+))