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Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients


Phase 3
N/A
N/A
Open (Enrolling)
Both
Lymphoproliferative Disorder

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Trial Information

Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients


OBJECTIVES:

- Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T
cells and reduction of immunosuppression, in terms of survival rate and time to
remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative
disease after solid organ transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment
arms.

- Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5
regimens at physician's discretion. Patients then receive partially HLA-matched
allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.

- Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are
followed monthly for 6 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ
(heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation

- Epstein-Barr virus-positive tumor

- Newly diagnosed disease

- Measurable disease by clinical methods or radiography

- Must have partially matched donor cytotoxic T cells (CTL) available

- No known panel reactivity to any of the HLA types of CTL available for therapy

PATIENT CHARACTERISTICS:

Age:

- Any age

Performance status:

- Karnofsky 20-100%

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No prior therapy for PTLD

- No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Complete response

Safety Issue:

No

Principal Investigator

Dorothy H. Crawford, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Edinburgh

Authority:

United States: Federal Government

Study ID:

CDR0000069288

NCT ID:

NCT00033475

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Lymphoproliferative Disorder
  • post-transplant lymphoproliferative disorder
  • Lymphoproliferative Disorders

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