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Photochemotherapy and Graft-versus-leukemia in Acute-leukemia

NCT02631993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2015-12-16

No results posted yet for this study

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

Interventions

RADIATION

Photochemotherapy

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Nicolas Feldreich, M.D. · Division of Therapeutic Immunology, Department of Laboratory Medicine, Karolinska Institute

  • Olle Ringden, Professor · Division of Therapeutic Immunology, Department of Laboratory Medicine, Karolinska Institute

  • Brigitta Omazic, PhD · Department of Oncology and Pathology,

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631993 on ClinicalTrials.gov