Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Summary

To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

Conditions

• Leukemia, Mast-Cell
• Mantle-cell Lymphoma

Interventions

PROCEDURE

Total lymphoid irradiation

Total lymphoid irradiation (TLI) administered at 80cGy for 10 days

DRUG

Rituximab

Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.

DRUG

Anti-thymoglobulin, rabbit (ATG, rabbit ATG)

Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.

DRUG

Cyclosporine

Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates \> 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).

DRUG

Mycophenylate mofetil

Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete

DRUG

Filgrastim

Filgrastim provided as needed for neutrophil support

DRUG

Granisetron

Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI

DRUG

Solumedrol

Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)

DRUG

Acetaminophen

Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC

DRUG

Diphenhydramine

Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC

DRUG

Hydrocortisone

Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

Sponsors & Collaborators

• The Leukemia and Lymphoma Society

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Stanford University

  lead OTHER

Principal Investigators

• David Miklos · Stanford University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

76 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-06-30

Primary Completion

2010-11-30

Completion

2010-12-31

Countries

• United States

Study Locations