CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Ofatumumab +5 moredrug
Likely dose
Ofatumumab 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01329900
NCT01329900Phase 2Completed
CompareCT.gov

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

M.D. Anderson Cancer Center·interventional·Posted Apr 6, 2011·Updated Jul 8, 2020

In Brief

A Phase 2 clinical trial evaluating Ofatumumab, Ifosfamide, and 4 other interventions for Lymphoma. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 6, 2011
Enrollment StartAug 22, 2011
Primary CompletionJul 21, 2019
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 15.2 years ago

Interventions

Ofatumumabdrug

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

Ifosfamidedrug

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

Etoposidedrug

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

Mesnadrug

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.

G-CSFdrug

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

Stem Cell Collectionprocedure

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.