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

NCT01329900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-07-08

Study results available
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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.

Conditions

Interventions

DRUG

Ofatumumab

1000 mg by vein on Day 1 and 2000 mg by vein on Day 8

DRUG

Ifosfamide

3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.

DRUG

Etoposide

150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.

DRUG

Mesna

2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts) 2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide) After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose.

DRUG

G-CSF

6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.

PROCEDURE

Stem Cell Collection

Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-22
Primary Completion
2019-07-21
Completion
2019-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01329900 on ClinicalTrials.gov