TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2026-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis

NCT03118492

Secondary Myelofibrosis

ACTIVE_NOT_RECRUITING PHASE1

External Beam Radiation Therapy in Combination With Talquetamab for the Treatment of Multiple Myeloma Patients With Extramedullary Disease

NCT06572605

Extramedullary Disease in Multiple Myeloma Multiple Myeloma

RECRUITING PHASE1/PHASE2

Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma

NCT01163357

Autologous Hematopoietic Stem Cell Transplant Recipient Loss of Chromosome 17p Plasma Cell Leukemia +2 more

COMPLETED PHASE1

Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients

NCT00040651

Scleroderma Systemic Sclerosis

TERMINATED PHASE1

Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

NCT00062140

Leukemia Lymphoma Myelodysplastic Syndromes +1 more

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To assess the feasibility of using IMRT to deliver total body irradiation (TBI) to 800 cGy while keeping mean lung and kidney doses to 200 cGy.

II. To assess the safety/feasibility of total body irradiation using IMRT (IMRT TBI) in systemic sclerosis patients undergoing autologous hematopoietic stem cell transplantation.

SECONDARY OBJECTIVES:

I. To evaluate dose homogeneity and dose sparing to lung and kidneys. II. To evaluate transplant-related mortality at 30 days and 100 days post IMRT TBI.

OUTLINE:

Patients undergo TBI using IMRT twice daily (BID) on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up on days 30 and 100.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Scleroderma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (TBI using IMRT, cyclophosphamide, HSCT)

Patients undergo TBI using IMRT BID on days -5 and -4 in the absence of disease progression or disease progression. Patients then receive cyclophosphamide on days -3 and -2 and undergo HSCT on day 0 in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Allogeneic Hematopoietic Stem Cell Transplantation

Intervention Type PROCEDURE

Undergo HSCT

Cyclophosphamide

Intervention Type DRUG

Undergo HSCT

Intensity-Modulated Radiation Therapy

Intervention Type RADIATION

Undergo TBI using IMRT

Total-Body Irradiation

Intervention Type PROCEDURE

Undergo TBI using IMRT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

Intervention Type PROCEDURE

Cyclophosphamide

Undergo HSCT

Intervention Type DRUG

Intensity-Modulated Radiation Therapy

Undergo TBI using IMRT

Intervention Type RADIATION

Total-Body Irradiation

Undergo TBI using IMRT

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Allogeneic Hematopoietic Cell Transplantation allogeneic stem cell transplantation HSC HSCT Stem Cell Transplantation, Allogeneic (-)-Cyclophosphamide 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate Carloxan Ciclofosfamida Ciclofosfamide Cicloxal Clafen Claphene CP monohydrate CTX CYCLO-cell Cycloblastin Cycloblastine Cyclophospham Cyclophosphamid monohydrate Cyclophosphamide Monohydrate Cyclophosphamidum Cyclophosphan Cyclophosphane Cyclophosphanum Cyclostin Cyclostine Cytophosphan Cytophosphane Cytoxan Fosfaseron Genoxal Genuxal Ledoxina Mitoxan Neosar Revimmune Syklofosfamid WR- 138719 IMRT Intensity Modulated RT Intensity-Modulated Radiotherapy Radiation, Intensity-Modulated Radiotherapy TBI Total Body Irradiation Whole Body Irradiation Whole-Body Irradiation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Karnofsky performance status (KPS) \>= 70
* Systemic sclerosis patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) per City of Hope (COH) guidelines and standard operating procedures (SOP) for autologous hematopoietic cell transplant
* Patients must be suitable for TBI conditioning regimens as part of transplant per radiation the referring hematologist
* Patients must have adequate organ function for HCT as determined by the hematologist
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation
* All subjects must have the ability to understand the treatment and the willingness to sign a written informed consent

Exclusion Criteria

* Patients should not have any uncontrolled illness including ongoing or active infection
* Prior history of radiation therapy must be presented to study principal investigator (PI) for eligibility determination
* Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No