Low-Dose Total Lymphoid Irradiation in Treating Patients With Refractory Chronic Graft-versus-Host Disease After Donor Stem Cell Transplant

NCT02109809 | Terminated Results FDA Device

• 4 other identifiers: IRB00026878NCI-2014-00671CCCWFU 97114P30CA012197
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the side effects and best dose of low-dose total lymphoid irradiation (LD-TLI) in treating patients with chronic graft-versus-host disease that has not responded to treatment with steroids. LD-TLI is a procedure in which all of the body's major lymph nodes are treated with small doses of radiation in order to reset the dysfunctional immune system. LD-TLI may work as a treatment for graft-versus-host disease caused by a bone marrow or stem cell transplant.

Conditions

Graft Versus Host Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events, Scored as Per Common Toxicity Criteria Version 4.0

  Toxicities (grade 2 and higher) will be reported as number of occurrences.

  At day 180

• Failure Free Survival (FFS) as Assessed by Scoring for Chronic GvHD - Specific Core Measures

  Estimated along with 95% confidence intervals (CI). Descriptive statistics will be calculated and presented for GvHD summary scores by dose level and visit.

  Time from baseline to date of last follow-up or failure event, assessed at day 180

Secondary Outcomes (1)

• Immunomodulatory/Immuno-suppressive Effects

  Up to 1 year

Study Arms (1)

Supportive Care (TLI)

EXPERIMENTAL

Patients undergo LD-TLI daily for 1-2 days.

Radiation: total nodal irradiation; Other: laboratory biomarker analysis; Other: questionnaire administration

Interventions

total nodal irradiation RADIATION

Undergo TLI

Also known as: TLI, total lymphoid irradiation

Supportive Care (TLI)

laboratory biomarker analysis OTHER

Correlative studies

Supportive Care (TLI)

questionnaire administration OTHER

Ancillary studies

Supportive Care (TLI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may have received a prior allogeneic hematopoietic stem cell transplant (alloHSCT) for any indication and from any donor
• Patients must have a diagnosis of cGvHD, in accordance with National Institutes of Health (NIH) guidelines; patients with "overlap syndrome" are also eligible; NOTE: Patients with recurrent, late onset and/or persistent acute GvHD (alone) are not eligible
• Patients with chronic GvHD who have been exposed to two or more lines of therapy, including at least one of which was composed of a glucocorticoid and a calcineurin inhibitor are eligible.
• Patients must have active, but not rapidly progressive, refractory cGvHD; any degree of severity (as per NIH criteria) and/or pattern of organ involvement may be considered; that said, patients with more severe and/or extensive chronic GvHD are expected to be the usual candidates for therapy
• As above, GvHD should be controlled to a degree that would potentially allow no additional requirement for systemic IST before and following TLI =\< -15 and \>= day (d) +45, respectively
• The ability to administer protocol doses of TLI (i.e., 100, 200 or 300 cGy) without exceeding cumulative doses of radiation must be established; for patients with prior radiotherapy exposure, this determination will be made by Dr. Greven (or her designee) using published guidelines for excessive organ exposure
• Karnofsky performance status (KPS) \>= 60%
• White blood cells \>= 3,000/mcL
• Absolute neutrophil count \>= 1,500/mcL
• Hemoglobin \>= 10.0 g/dL
• Platelets \>= 100,000/mcL
• NOTE: If such hematologic abnormalities are present and deemed due to the process of cGvHD, such requirements may be waived with the approval of the PI
• Patients must have non-hematologic organ function as defined below:
• Left ventricular ejection fraction (LVEF) \> 40%
• Key pulmonary function tests (PFTs) \> 40%

You may not qualify if:

• Patients with evidence of persistent or active malignancy or uncontrolled infection at the time of study entry
• Patients who are pregnant or breastfeeding

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Dr. Gordon Phillips
• Organization: Wake Forest University Health Sciences

gophilli@wakehealth.edu

336-716-0659

Study Officials

• Gordon Phillips

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-10

Locations

US (1)