Overview

Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma

Status:
Completed

Trial end date:
2015-07-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Ortho Biotech, Inc.

Treatments:

BB 1101
Cyclophosphamide
Cytarabine
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Lenograstim
Liposomal doxorubicin
Mesna
Methotrexate
Vincristine

Criteria

Inclusion Criteria:

1. Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK
lymphomas, with the exception of cluster of differentiation antigen 30 (CD30+) alk1+
T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also
excluded. For patients with skin involvement as part of systemic disease, prior
topical treatment only is allowed.

2. Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).

3. Serum bilirubin lymphoma; Absolute neutrophil count (ANC) >/= 1000 mm^3 and platelets >/= 100,000 mm^3
unless due to lymphoma.

4. Cardiac ejection fraction 50% or greater by multigated radionuclide angiography (MUGA)
or echocardiogram.

5. Ages 18 and older.

6. Patients must be willing to receive transfusions of blood products.

Exclusion Criteria:

1. Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with
skin involvement alone.

2. Pregnancy

3. HIV positive serology

4. Central nervous system (CNS) involvement

5. Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease,
and symptomatic congestive heart failure, or psychiatric illnesses that preclude
treatment with intense dose chemotherapy as determined by the primary investigator

6. Concurrent or previous malignancy whose prognosis is poor (<90% probability of
survival at 5 years)