Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04380831 · ClinicalTrials.gov registry record · Early Phase 1
TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis
A Early Phase 1 study of Systemic Scleroderma, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04380831: Recruiting Early Phase 1 study of Systemic Scleroderma, sponsored by City of Hope Medical Center.
NCT04380831 is a Early Phase 1 study of Systemic Scleroderma that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 15 participants, below the 51-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380831, a Early Phase 1 study of Systemic Scleroderma, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.
Primary Outcome
The study will be deemed feasible if \>= 80% of patients complete the intensity modulation radiation therapy (IMRT) to the total dose of 800 cGy, mean lung and kidney doses are limited to 200 cGy or less.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- RADIATION Intensity-Modulated Radiation Therapy
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- PROCEDURE Total-Body Irradiation
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-02-24 |
| Est. Completion | 2026-12-22 |
| Phase | Early Phase 1 |
What NCT04380831 shows while recruiting
NCT04380831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 51-participant average among 4 other Systemic Scleroderma trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Systemic Scleroderma appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04380831 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04380831 about?
NCT04380831 is a clinical study titled "TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis". This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy...
What is the current status of trial NCT04380831?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2022-02-24. Estimated completion is 2026-12-22.
What conditions does trial NCT04380831 study?
This clinical trial studies the following conditions: Systemic Scleroderma.
What interventions are being tested in trial NCT04380831?
The interventions under investigation include: Cyclophosphamide (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Total-Body Irradiation (PROCEDURE).
Who is sponsoring clinical trial NCT04380831?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04380831 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Scleroderma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
RECRUITING · NA
-
Longitudinal Spatial Frequency Domain Imaging Study
ACTIVE NOT RECRUITING · NA
-
CLUE Study: Connective Tissue Disease Leg Ulcer Etiology Study
COMPLETED
-
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI