Test Extracorporeal Photopheresis (ECP) Treatment Before/After Allogeneic Bone Marrow Transplant (BMT) or Peripheral Blood Stem Cell (PBSC) Transplant to Prevent Graft Versus Host Disease

NCT01174940 | Completed Early Phase 1 DMC

• 1 other identifier: 12047
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

To study the effect of ECP with Uvadex® in conjunction with a standard myeloablative conditioning regimen on the incidence of acute and chronic GvHD in patients undergoing an allogeneic related or unrelated BMT or PBSC transplant, for treatment of hematologic or lymphoproliferative malignancies.

Conditions

Stem Cell Leukemia of Unclear Lineage; Graft Versus Host Disease

Keywords

myelogenous leukemia; lymphocytic leukemia; lymphoblastic leukemia; myelodysplastic syndrome; non-Hodgkin's lymphoma; Hodgkin's disease

Outcome Measures

Primary Outcomes (1)

• Presence/absence of grade II-IV acute Graft versus Host Disease (aGVHD)

  The primary efficacy variable is the presence/absence of grade II-IV acute GvHD within the first 100 days after transplantation

  100 days after transplant

Secondary Outcomes (1)

• proportion of patients who develop chronic Graft versus Host Disease (cGVHD) and experience relapse of primary disease.

  365 days after transplantation

Study Arms (1)

Extracorporeal Photopheresis

EXPERIMENTAL

Patients will receive 2 ECP treatments on day -10 and day -8 and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.

Drug: extracorporeal photopheresis

Interventions

extracorporeal photopheresis DRUG

Patients will receive 2 ECP treatments prior to the commencement of the high dose chemotherapy and then for two consecutive days every two weeks starting from post engraftment (ANC \> 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure. The dose of UVADEX® used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, using the following formula: Treatment Volume in mL X 0.017 of UVADEX® (20 mcg/ml) required for administration into the recirculation bag = Amount of UVADEX® (in mLs) required for administration into the recirculation bag. After the cells are inoculated with UVADEX®, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then re-infused back into the patient.

Also known as: UVAR, UVAR XTS

Extracorporeal Photopheresis

Eligibility Criteria

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

You may qualify if:

• Patients are eligible if they have a diagnosis of one of the following hematologic or lymphoproliferative malignancies for which a treatment option would be an allogeneic BMT or PBSC transplant:
• acute myelogenous leukemia
• chronic myelogenous leukemia
• acute lymphocytic/blastic leukemia
• chronic lymphocytic leukemia
• myelodysplastic syndrome
• non-Hodgkin's lymphoma (expected survival \> 60 days)
• Hodgkin's disease (expected survival \> 60 days)
• Patients who are candidates for a standard allogeneic BMT or patients who are candidates for a standard allogeneic PBSC transplant.
• Patients must have a suitable HLA- molecular matched (8/10 or more) related or unrelated donor.
• Patients must be physically and psychologically capable of undergoing a BMT or PBSC transplant and the attendant period of strict isolation.
• Patients must test negative for human immunodeficiency virus (HIV).
• Patients must present no evidence of active ongoing infection.
• Patients must have adequate renal, hepatic, pulmonary, and cardiac function to enable the patient to tolerate the extracorporeal volume shifts associated with ECP, as determined by the physician's clinical judgment.
• Platelets ≥ 20,000/cmm.

You may not qualify if:

• Patients who have received a prior allogeneic BMT or PBSC transplant.
• Hypersensitivity or allergy to psoralen (methoxsalen).
• Contraindication to radiation, cyclophosphamide, CSA, Busulphan or MTX.
• Patients whose treatment requires donor lymphocyte infusion up to day 100 post-transplant.
• Participation in another clinical trial for prevention of GvHD within 7 days prior to patient enrollment or concurrent participation in any other clinical study.
• Active gastrointestinal bleeding.
• Females who are pregnant or lactating.
• Previous treatment with ECP.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Mallinckrodt: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia, Myeloid; Leukemia, Lymphoid; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Photopheresis

Condition Hierarchy (Ancestors)

Immune System Diseases; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Lymphoma

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Sunil Abhyankar, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: August 4, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2015
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

US (1)