Photopheresis for the Treatment of Acute Graft Versus Host Disease - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00609609

Purpose

Primary Objective:

To assess the efficacy of photopheresis (extracorporeal photochemotherapy or ECP) in combination with methylprednisolone for the up-front treatment of acute graft-versus-host disease (GvHD) compared with methylprednisone alone.

Secondary Objectives:

To assess the safety of the combination of corticosteroids with ECP.
To assess the 6 months survival of these patients.
To assess the steroid sparing effect of photopheresis.

Condition	Intervention	Phase
Graft Versus Host Disease	Procedure: Photopheresis Drug: Methylprednisolone	Phase II

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Phase II Study for the Evaluation of Extracorporeal Photopheresis (ECP) in Combination With Corticosteroids for the Initial Treatment of Acute Graft-Versus-Host Disease (GVHD)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find out whether adding extracorporeal photopheresis (ECP) to standard therapy for acute GVHD with corticosteroids improves response to treatment, length of treatment, and survival. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Methylprednisolone	Drug: Methylprednisolone 2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.
2: Experimental Photopheresis + Methylprednisolone	Procedure: Photopheresis 4 photopheresis treatments weekly for days 1-14, 3 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments. Drug: Methylprednisolone 2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.

Arms

Assigned Interventions

1: Experimental

Methylprednisolone

Drug: Methylprednisolone

2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.

2: Experimental

Photopheresis + Methylprednisolone

Procedure: Photopheresis

4 photopheresis treatments weekly for days 1-14, 3 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60. After day 60, your doctor will decide whether ECP is worth continuing, and the frequency of treatments.

Drug: Methylprednisolone

2 mg/kg daily with a taper to no less than 1 mg/kg/day by day 14, followed by a tapering schedule according to the suggested guidelines.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be recipients of allogeneic bone marrow or stem cell grafts.
Patient must weigh above 40 kg
Patients must have new onset, clinical grade II-III acute GVHD of the GI tract or liver, or the skin that developed within 100 days post transplantation. The diagnosis of GVHD must be pathologically confirmed in at least one organ. Pathological confirmation may occur after registration and after the start of therapy.
Patients must be able to sustain a platelet count and a hematocrit > 20,000/mL and > 27% respectively, with or without transfusions.
The absolute WBC must be >1500/mL
Patient must be willing to comply with all study procedures.
All patients with childbearing potential, including males and females, must commit to using adequate contraceptive precautions throughout their participation in the study and for 3 months following the last ECP treatment.

Exclusion Criteria:

Patients developing acute GVHD after day 100, or following immune modulation with immunosuppression withdrawal or donor lymphocyte infusion (DLI)
Patients who are unable to tolerate the volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe asthma or chronic obstructive pulmonary disease, hepatorenal syndrome.
Active bleeding
International normalized ration (INR) >2
Patients cannot have received methylprednisolone > 2mg/kg/day for more than 48 hours prior to registration.
Patients cannot have received any other immunosuppression for treatment of GVHD but calcineurin inhibitors and corticosteroids. Patients are allowed to have had any GVHD prophylaxis with the exception of ECP
Patients with known hypersensitivity or allergy to psoralen
Patients with known hypersensitivity or allergy to both citrate and heparin
Patients with co-existing melanoma, basal cell or squamous cell carcinoma, aphakia, photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders
Uncontrolled, persistent hypertriglyceridemia, with levels > 800 mg%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00609609

Contacts

Contact: Amin Alousi, MD

713-792-8750

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Amin Alousi, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Amin Alousi, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Amin Alousi, MD/Assistant Professor )
Study ID Numbers:	2005-1022
Study First Received:	January 23, 2008
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00609609
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Graft Versus Host Disease
Extracorporeal Photopheresis
Methylprednisolone
Medrol
Photopheresis

GVHD
ECP
Allogeneic bone marrow graft
Stem cell graft

Study placed in the following topic categories:

Methylprednisolone
Graft versus host disease
Prednisolone
Methylprednisolone acetate

Graft vs Host Disease
Prednisolone acetate
Methylprednisolone Hemisuccinate
Homologous wasting disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones

Neuroprotective Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009