Overview

Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

Status:
Completed
Trial end date:
2019-07-21
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if it is possible to collect stem cells after ofatumumab and chemotherapy treatment. This study will also evaluate side-effects, number of stem cells collected, and the number of procedures that are needed to collect enough stem cells.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Novartis
Treatments:
Antibodies, Monoclonal
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Lenograstim
Mesna
Ofatumumab
Sargramostim
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for
autologous SCT.

2. Patients must have PR to salvage chemotherapy.

3. Age 18-70 years.

4. Platelet count >/= 100,00 mm³ independent of transfusion support.

5. Absolute neutrophil count >/= 1500/mm³.

6. Zubrod performance status (PS) 2 or less.

7. Negative serum pregnancy test in women of childbearing potential. This is a female who
has not been postmenopausal for at least 12 consecutive months or who has not
undergone previous surgical sterilization.

8. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by
unilateral bone marrow aspiration and biopsy.

9. Seronegativity for HIV, HTLV1, Hepatitis .

Exclusion Criteria:

1. Subjects who have current active hepatic ( (HbsAg, HbcAb, and positive viral load by
PCR) or biliary disease (with exception of patients with Gilbert's syndrome,
asymptomatic gallstones, liver metastases or stable chronic liver disease per
investigator assessment) with ALT > 2x upper limit of normal or bilirubin > 1.5.
(Consult with a physician experienced in care and management of subjects with
hepatitis B to manage/treat subjects who are anti-HBc positive.)

2. Active CNS disease.

3. Severe concomitant medical or psychiatric illness.

4. Lactating or breast feeding females.

5. Serum creatinine >1.6 mg/dl.

6. History of pelvic radiation.

7. Fludarabine-based chemotherapy within 6 months.