Photochemotherapy and Graft-versus-leukemia in Acute-leukemia

NCT02631993 | Completed

• 1 other identifier: TIM Photochem 2
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Cure of leukemia after hematopoietic stem cell transplantation (HSCT) is sustained by the anti-leukemic effect of the grafted cells (graft-versus-leukemia (GVL)). However, it is not known whether the tumor-immunity is affected by photochemotherapy (psoralene photosensitization and ultraviolet light radiation) administered to attenuate graft-versus host disease (GVHD). The present study aim to investigate what happens to the GVL after photochemotherapy of aGVHD in a predominantly retrospective setting with 10-years follow-up after HSCT

Conditions

ALL; AML; Acute GVHD; Tumor Immunity

Keywords

Psoralen; UVA; Time-to-treatment; GVL

Outcome Measures

Primary Outcomes (1)

• Graft-versus-leukemia (GVL)

  i.e. abscence of relapse in malignant disease or minimal residual disease (MRD) i.e. threatening relapse in malignant disease demanding donor lymphocyte infusion (DLI).

  10-years after HSCT (2005 - 2015)

Secondary Outcomes (3)

• Death

  10-years after HSCT (2005 - 2015)

• Retransplantation

  10-years after HSCT (2005 - 2015)

• Donor Lymphocyte Infusion (DLI)

  10-years after HSCT (2005 - 2015)

Interventions

Photochemotherapy RADIATION

Oral 8-Methoxypsoralene (8-MOP), (0.4-0.8 mg/kg), are given 1.5-2 hours before phototherapy. Ultraviolet light type A (UVA, 320-400 nm) is administered in a Waldmann UV1000 supine unit through 26 100-W fluorescent PUVA lamps (Waldmann F85), if needed, UVA is given in a half body unit with 15 100-W PUVA-lamps (Waldmann F85), (Waldmann UV3003K), (Waldmann, Villingen-Schwenningen, Germany). Eye protection is applied during 24 h after oral 8-MOP and the genital area are shielded in males during therapy.The UVA is initiated at 0.2-1.5 J/cm2 and is amplified by 0.25-0.5 J/cm2 after two treatments if photo toxicity is absent. PUVA is given to the patients 3-5 times each week.

Also known as: Psoralen and Ultraviolet light Type A (PUVA)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AML or ALL having received photochemotherapy for aGVHD evoked by HSCT given at Center for Allogeneic Stem Cell transplantation (CAST) between 1985 - end of 2004.

You may qualify if:

• Eligible patients received photochemotherapy (Ultraviolet radiation type A on skin photosensitized by oral 8-methoxypsoralen) for acute graft-versus-host disease (GVHD within 100-days after HSCT). Photochemotherapy may be given as primary or later aGVHD therapy.

You may not qualify if:

• Patients with aGVHD after booster doses of stem-cells or donor-lymphocyte-infusions are not included.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Department of Dermatology, Karolinska University Hospital Huddinge

Stockholm, Stockholm County, 14186, Sweden

Location

Related Publications (12)

• Thomas E, Storb R, Clift RA, Fefer A, Johnson FL, Neiman PE, Lerner KG, Glucksberg H, Buckner CD. Bone-marrow transplantation (first of two parts). N Engl J Med. 1975 Apr 17;292(16):832-43. doi: 10.1056/NEJM197504172921605. No abstract available.

  PMID: 234595 BACKGROUND

• Ringden O, Witherspoon RP, Storb R, Ekelund E, Thomas ED. Increased in vitro B-cell IgG secretion during acute graft-versus-host disease and infection. Observations in 50 human marrow transplant recipients. Blood. 1980 Feb;55(2):179-86.

  PMID: 6986176 BACKGROUND

• Ringden O, Sundberg B, Lonnqvist B, Tollemar J, Gahrton G, Nilsson B. Allogeneic bone marrow transplantation for leukemia: factors of importance for long-term survival and relapse. Bone Marrow Transplant. 1988 Jul;3(4):281-90.

  PMID: 3048493 BACKGROUND

• Alyea EP, DeAngelo DJ, Moldrem J, Pagel JM, Przepiorka D, Sadelin M, Young JW, Giralt S, Bishop M, Riddell S. NCI First International Workshop on The Biology, Prevention and Treatment of Relapse after Allogeneic Hematopoietic Cell Transplantation: report from the committee on prevention of relapse following allogeneic cell transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2010 Aug;16(8):1037-69. doi: 10.1016/j.bbmt.2010.05.005. Epub 2010 May 24.

  PMID: 20580849 BACKGROUND

• Horowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, Rimm AA, Ringden O, Rozman C, Speck B, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990 Feb 1;75(3):555-62.

  PMID: 2297567 BACKGROUND

• Ringden O, Labopin M, Solders M, Beelen D, Arnold R, Ehninger G, Milpied N, Niederwieser D, Hamladji RM, Kyrcz-Krzemien S, Ganser A, Socie G, Stelljes M, Volin L, Craddock C, Mohty M; Acute Leukaemia Working Party of the European Group for Blood and Marrow Transplantation. Who is the best hematopoietic stem-cell donor for a male patient with acute leukemia? Transplantation. 2014 Sep 15;98(5):569-77. doi: 10.1097/TP.0000000000000102.

  PMID: 24798307 BACKGROUND

• Strauss GH, Bridges BA, Greaves M, Hall-Smith P, Price M, Vella-Briffa D. Inhibition of delayed hypersensitivity reaction in skin (DNCB test) by 8-methoxypsoralen photochemotherapy. Possible basis for pseudo-promoting action in skin carcinogenesis? Lancet. 1980 Sep 13;2(8194):556-9. doi: 10.1016/s0140-6736(80)91992-3.

  PMID: 6106738 BACKGROUND

• Wolf P, Nghiem DX, Walterscheid JP, Byrne S, Matsumura Y, Matsumura Y, Bucana C, Ananthaswamy HN, Ullrich SE. Platelet-activating factor is crucial in psoralen and ultraviolet A-induced immune suppression, inflammation, and apoptosis. Am J Pathol. 2006 Sep;169(3):795-805. doi: 10.2353/ajpath.2006.060079.

  PMID: 16936256 BACKGROUND

• Glucksberg H, Storb R, Fefer A, Buckner CD, Neiman PE, Clift RA, Lerner KG, Thomas ED. Clinical manifestations of graft-versus-host disease in human recipients of marrow from HL-A-matched sibling donors. Transplantation. 1974 Oct;18(4):295-304. doi: 10.1097/00007890-197410000-00001. No abstract available.

  PMID: 4153799 BACKGROUND

• Parrish JA, Fitzpatrick TB, Tanenbaum L, Pathak MA. Photochemotherapy of psoriasis with oral methoxsalen and longwave ultraviolet light. N Engl J Med. 1974 Dec 5;291(23):1207-11. doi: 10.1056/NEJM197412052912301. No abstract available.

  PMID: 4422691 BACKGROUND

• Ringden O, Karlsson H, Olsson R, Omazic B, Uhlin M. The allogeneic graft-versus-cancer effect. Br J Haematol. 2009 Dec;147(5):614-33. doi: 10.1111/j.1365-2141.2009.07886.x. Epub 2009 Sep 4.

  PMID: 19735262 BACKGROUND

• Hari P, Logan B, Drobyski WR. Temporal discordance between graft-versus-leukemia and graft-versus-host responses: a strategy for the separation of graft-versus-leukemia/graft-versus-host reactivity? Biol Blood Marrow Transplant. 2004 Nov;10(11):743-7. doi: 10.1016/j.bbmt.2004.07.006.

  PMID: 15505605 BACKGROUND

MeSH Terms

Interventions

Photochemotherapy; Ficusin

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Nicolas Feldreich, M.D.

  Division of Therapeutic Immunology, Department of Laboratory Medicine, Karolinska Institute

  PRINCIPAL INVESTIGATOR

• Olle Ringden, Professor

  Division of Therapeutic Immunology, Department of Laboratory Medicine, Karolinska Institute

  STUDY DIRECTOR

• Brigitta Omazic, PhD

  Department of Oncology and Pathology,

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: December 16, 2015
• Study Start: October 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

SE (1)