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Trial record 1 of 1 for:    NCT00609609
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Photopheresis for the Treatment of Acute Graft Versus Host Disease

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ClinicalTrials.gov Identifier: NCT00609609
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is 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.

Condition or disease Intervention/treatment Phase
Graft Versus Host Disease Procedure: Photopheresis Drug: Methylprednisolone Phase 2

Detailed Description:

ECP uses ultraviolet A radiation to treat lymphocytes. Although the exact reason why ECP may be beneficial is not completely understood, researchers believe that the lymphocytes treated this way are less likely to continue causing GVHD.

In this study, researchers want to evaluate whether adding another treatment to standard therapy with corticosteroids, in this case ECP, will improve the response to therapy, duration of therapy, and survival. After the diagnosis of acute GVHD, you will be randomly selected (at the toss of a coin) to be in one of 2 treatment groups. One group will receive treatment with corticosteroids (like methylprednisolone or prednisone) alone, and the other will receive ECP treatments in addition to the corticosteroids. ECP treatments are explained below.

In order to have ECP, you will need a special central venous catheter similar to the one you have now. A central venous catheter is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your physician will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.

Blood is drawn by a machine called "photopheresis machine". This blood goes into a bowl inside the machine, where it is spun and separated into white cells (called buffy coat), red cells, and platelets. The red cells and platelets are promptly returned to you, while the white cells in the buffy coat undergo the process of ECP. The buffy coat will come out of the bowl and will be mixed with a substance called methoxsalen, that will make lymphocytes more sensitive to the effects of light. After mixing with methoxsalen, the buffy coat goes in to chamber where it is exposed to ultraviolet A radiation, and from there back to you. This process is done gradually, in cycles, and takes about 3 hours.

You will have up to 4 of these treatments weekly for the first 14 days of therapy, then 3 treatments weekly from Day 15-28, and after that 2 treatments weekly until Day 60, which is the end of the study. After Day 60, your doctor will decide whether ECP is worth continuing, and also the frequency of treatments. It is not necessary to be in the study to continue to receive ECP treatments. If you respond to the treatment, your corticosteroids will be reduced slowly to prevent the GVHD from coming back.

The length of corticosteroid therapy will depend on how GVHD responds to the treatment. You will follow a corticosteroid therapy tapering schedule according to the suggested guidelines. You will continue to receive tacrolimus or cyclosporine, whichever you have been using as GVHD prevention, throughout the study independent of what treatment group you are assigned.

While you are getting treatment in this study, every week you will have a physical exam and blood (about 1 tablespoon) will be drawn for routine tests. If your doctor thinks it is necessary, blood may be drawn more often.

You will be considered off-study after 6 months of treatment completion. You will be taken off study if you are unable to comply with study requirements, you refuse to continue participation in the study, or intolerable side effects occur.

This is an investigational study. ECP has been approved by the FDA for the treatment of a certain type of lymphomas of the skin and is commercially available. Its use in patients with GVHD is considered to be investigational. Up to 95 patients will take part in this study. All will be enrolled at MD Anderson.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : January 2008
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Experimental: Corticosteroids
Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
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.
Other Names:
  • Medrol
  • Depo-Medrol
  • Solu-Medrol

Experimental: ECP + Corticosteroids
Extracorporeal Photopheresis (ECP) 8-9 treatments weekly for days 1-14, 6 treatments weekly from days 15-28, and after that 2 treatments weekly until day 60 + Methylprednisolone at a dose of 2 mg/kg/day with a taper to no less than 1 mg/kg/day by day 14, and no less than 0.4 mg/kg/day by day 28.
Procedure: Photopheresis
8-9 photopheresis treatments weekly for days 1-14, 6 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.
Other Names:
  • Extracorporeal Photopheresis
  • ECP

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.
Other Names:
  • Medrol
  • Depo-Medrol
  • Solu-Medrol

Primary Outcome Measures :
  1. Day 56 Treatment Success [ Time Frame: Day 1 to Day 63 (approximately 9 weeks), Acute GVHD scored weekly. ]
    Definition of Treatment Failure: No Response according to the following: A) Skin: 1) No change in GVHD stage by day 14; 2) Gut: No change in GVHD stage by Day 7; 3) Liver: No change in GVHD stage by Day 21. B) Progressive Disease (PD): 1) Skin/Gut: Increase in Stage by 72 hours from the start of therapy; 2) Liver: Increase in Stage by Day 14; 3) Initiation of 2nd line treatment at any time for acute GVHD: 4) Any new organ involvement by acute GVHD. C) Inability to Taper: 1) Patient still on >1 mg/kg/d of methylprednisolone equivalent at 1 month. 2) Patient still on > 0.5 mg/kg/d of methylprednisolone equivalent at 2 months; 3) Death from GVHD. Definition of Treatment Success: Participants not defined above in Treatment Failure definition. Baseline biopsy with Acute GVHD assessed weekly until last ECP procedure (anticipated Day 63). At 6 months follow up with a phone call for survival and GVHD status.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients must be recipients of allogeneic bone marrow or stem cell grafts.
  2. Patient must weigh above 40 kg
  3. Patients must have new onset, clinical grade II-III acute or late-acute GVHD of the GI tract or liver, or the skin that developed post transplantation. The diagnosis of GVHD must be pathologically confirmed in at least one organ or highly suspected clinically. Pathological confirmation may occur after registration and after the start of therapy. Definition of Late Acute GVHD vs Acute GVHD: The diagnosis of Late Acute GVHD includes clinical features that are identical to Acute GVHD, however, Late Acute GVHD is diagnosed on or after day 100 post transplantation.
  4. Continued from #3: These manifestations include a maculopapular rash, abnormal liver studies (cholestatic jaundice) and/or nausea/vomiting / diarrhea. Patients must not have any concurrent classical features of chronic GVHD in addition to the above manifestations. Features of chronic GVHD include dry eyes and mouth, contractures, and/ or sclerodermal, lichenoid skin changes.
  5. In the clinical judgment of the PI, patients must be able to sustain a platelet count and a hematocrit >/= 20,000/mL and >/= 27% respectively, with or without transfusions.
  6. The absolute white blood cell count (WBC) must be >1500/mL
  7. Patient must be willing to comply with all study procedures.
  8. 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:

  1. Patients developing chronic GVHD following immune modulation with immunosuppression withdrawal or donor lymphocyte infusion (DLI).
  2. Any clinical Manifestation consistent with de novo chronic GVHD or overlapped syndrome of acute and chronic GVHD.
  3. 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.
  4. Active bleeding
  5. International normalized ration (INR) >2
  6. Patients cannot have received methylprednisolone > 2mg/kg/day for more than 72 hours prior to registration.
  7. 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
  8. Patients with known hypersensitivity or allergy to psoralen
  9. Patients with known hypersensitivity or allergy to both citrate and heparin
  10. Patients with co-existing photosensitive disease (e.g. porphyria, systemic lupus erythematosus, albinism) or coagulation disorders.
  11. Uncontrolled, persistent hypertriglyceridemia, with levels > 800 mg%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00609609

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Amin Alousi, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00609609    
Other Study ID Numbers: 2005-1022
NCI-2012-01751 ( Registry Identifier: NCI CTRP )
First Posted: February 7, 2008    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: May 2018
Keywords provided by M.D. Anderson Cancer Center:
Allogeneic stem cell grafts
Allogeneic bone marrow graft
Blood and Marrow Transplantation
Stem cell graft
Graft Versus Host Disease
Extracorporeal Photopheresis
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents