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A Phase I/II Multicentric Study to Determine the Safety and Efficacy of a Combination of Anti-CD3 & Anti-CD7 Ricin A Immunotoxins for the Treatment of Steroid-Resistant Acute Graft-Versus-Host Disease


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Acute Graft Versus Host Disease

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Trial Information

A Phase I/II Multicentric Study to Determine the Safety and Efficacy of a Combination of Anti-CD3 & Anti-CD7 Ricin A Immunotoxins for the Treatment of Steroid-Resistant Acute Graft-Versus-Host Disease


"The experimental design is a non-controlled multicentric fixed-dose Phase I/II study. A
total of 12 evaluable patients will be enrolled in 4 transplant centers throughout the
Netherlands, in a 9 to 12 months period. The treatment consists of a standard dose of 4
infusions IT-combination (4 mg/m2), given 48-hours apart over a 4-hour period.

The intended follow-up period is 12 months. The patient will also be asked to participate
in additional research aiming at determining the presence and evolution of biomarkers
suggestive for the extent to which the IT-combination 'resets the T-cell compartment,
induces clinical tolerance, and/or enhances the risk of over-immunosuppression."


Inclusion Criteria:



- Patients suffering from severe acute GVHD (Grade II-IV) progressing after 3 days, or
non-improving after 5 days, of prednisolone at 2 mg/kg a day.

- Age ≥ 18 years.

- Patients or their guardians should have given written informed consent using forms
approved by the Institutional Review Board.

Exclusion Criteria:

- Patients receiving concomitant investigational therapeutics/prophylaxis for acute
GVHD at the time of enrollment.

- Patients with histological signs/symptoms suggestive of chronic GVHD.

- Patients requiring mechanical ventilation, requiring vasopressor support, requiring
hemodialysis, having serum creatinine > 266 μmol/l (> 3 mg/dl), or having a serum
albumin level of 20 g/l or less.

- Patients having uncontrolled bacterial, viral or fungal infections at the start of
therapy.

- Patients with current evidence of active intrapulmonary disease.

- Patients with known hypersensitivity to any of the components of the study drug
(murine mAb or RTA).

- Patients who are pregnant, breast feeding, or, if sexually active, unwilling to use
effective birth control for the duration of the study.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The acute GVHD response rate on study Day 29

Outcome Time Frame:

Day 29

Safety Issue:

No

Principal Investigator

Anton V Schattenberg,, MD, PhD,

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hematology Radboud University Nijmegen (RUN) Medical Centre

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

HN019/ITC-001

NCT ID:

NCT00640497

Start Date:

January 2010

Completion Date:

January 2012

Related Keywords:

  • Acute Graft Versus Host Disease
  • acute GVHD
  • immunotoxin
  • anti-CD3
  • anti-CD7
  • Ricin A
  • Graft vs Host Disease

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