Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma

Summary

Primary Objectives:

1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL).
2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL.
3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H.
4. To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.

Conditions

• Lymphoma

Interventions

DRUG

Campath-1H

3 mg through the catheter Day 1 then 10 mg on Day 2, and 30 mg on Days 3 and 10 of chemotherapy treatment.

DRUG

G-CSF

10 mg/kg subcutaneously (sc) on day +5 (in a.m.) for Stem Cell Mobilization.

DRUG

GM-CSF

250 m/m2 subcutaneously (sc) on Day +5 (in p.m.) for Stem Cell Mobilization.

DRUG

BCNU

300 mg/m2 IV over 1 hour on day -6

DRUG

Stem Cell Transplant

Stem cell infusion on Day 0.

DRUG

Preparative Regimen for Allogenic Stem Cell Transplantation

Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy on day 0.

DRUG

Cytarabine

200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses),

DRUG

Etoposide

200 mg/m2 IV twice on day -5 to -2 (total 8 doses)

DRUG

Melphalan

140 mg/m2 IV on day -1.

DRUG

Campath

15 mg/day (days -6 to -4) for preparative regimen Allogenic Stem Cell Transplantation

DRUG

Fludarabine

30 mg/m2 IV/day (days -6 to -4)

DRUG

Cyclophosphamide

750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4).

RADIATION

Low dose total body irradiation

Low dose total body irradiation of 2 Gy day 0.

Sponsors & Collaborators

• Bayer

  collaborator INDUSTRY

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Issa F. Khouri, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-03-31

Primary Completion

2009-11-30

Completion

2009-11-30

Countries

• United States

Study Locations