Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Aug 2011
Typical duration for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 6, 2011
CompletedStudy Start
First participant enrolled
August 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2019
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedJuly 8, 2020
June 1, 2020
7.9 years
April 4, 2011
June 19, 2020
June 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mobilization Rate
Feasibility of mobilization with ofatumumab + chemotherapy is defined as successful collection of 2 x 10\^6CD34+ stem cell/kg and successful purging of the apheresis product of all the markers (i.e., monoclonal B-cells, bcl-2, bcl-1 and/or JH) that were found to be positive on pretreatment evaluation. Mobilization rate is number of participants with successful collection out of total study participants.
Mobilization rate measured on Day 21
Study Arms (1)
Ofatumumab + Stem Cell Collection
EXPERIMENTALOfatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 3.33 gm/m2 by vein on Days 2, 3, and 4 continuously. Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses. Mesna 2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts). Mesna 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-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. 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.
Interventions
1000 mg by vein on Day 1 and 2000 mg by vein on Day 8
3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.
150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.
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.
6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.
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.
Eligibility Criteria
You may qualify if:
- Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for autologous SCT.
- Patients must have PR to salvage chemotherapy.
- Age 18-70 years.
- Platelet count \>/= 100,00 mm³ independent of transfusion support.
- Absolute neutrophil count \>/= 1500/mm³.
- Zubrod performance status (PS) 2 or less.
- 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.
- Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy.
- Seronegativity for HIV, HTLV1, Hepatitis .
You may not qualify if:
- 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.)
- Active CNS disease.
- Severe concomitant medical or psychiatric illness.
- Lactating or breast feeding females.
- Serum creatinine \>1.6 mg/dl.
- History of pelvic radiation.
- Fludarabine-based chemotherapy within 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Novartiscollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Issa F Khouri, M.D. / Stem Cell Transplantation
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Issa F. Khouri, MD,BS
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 6, 2011
Study Start
August 22, 2011
Primary Completion
July 21, 2019
Study Completion
July 21, 2019
Last Updated
July 8, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-06