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

PHASE2TerminatedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

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.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER