Trial Outcomes & Findings for Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas (NCT NCT01329900)
NCT ID: NCT01329900
Last Updated: 2020-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Mobilization rate measured on Day 21
Results posted on
2020-07-08
Participant Flow
Participant milestones
| Measure |
Ofatumumab + Stem Cell Collection
Ofatumumab 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.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Ofatumumab + Stem Cell Collection
Ofatumumab 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.
|
|---|---|
|
Overall Study
Elevated creatinine/renal function
|
1
|
Baseline Characteristics
Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas
Baseline characteristics by cohort
| Measure |
Ofatumumab + Stem Cell Collection
n=50 Participants
Ofatumumab 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mobilization rate measured on Day 21Feasibility 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.
Outcome measures
| Measure |
Ofatumumab + Stem Cell Collection
n=50 Participants
Ofatumumab 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.
|
|---|---|
|
Mobilization Rate
|
50 Participants
|
Adverse Events
Ofatumumab + Stem Cell Collection
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ofatumumab + Stem Cell Collection
n=50 participants at risk
Ofatumumab 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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.0%
1/50 • 5 years
|
Other adverse events
| Measure |
Ofatumumab + Stem Cell Collection
n=50 participants at risk
Ofatumumab 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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
4.0%
2/50 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
10/50 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
1/50 • 5 years
|
|
Investigations
Blood bilirubin increased
|
4.0%
2/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
18.0%
9/50 • 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.0%
1/50 • 5 years
|
|
Cardiac disorders
Chest pain
|
2.0%
1/50 • 5 years
|
|
General disorders
Chills
|
6.0%
3/50 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
12.0%
6/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
2/50 • 5 years
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
16.0%
8/50 • 5 years
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
7/50 • 5 years
|
|
General disorders
Edema limbs
|
12.0%
6/50 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • 5 years
|
|
Eye disorders
Eye disorders
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Facial muscle weakness
|
2.0%
1/50 • 5 years
|
|
General disorders
Fatigue
|
52.0%
26/50 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.0%
6/50 • 5 years
|
|
General disorders
Fever
|
2.0%
1/50 • 5 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.0%
2/50 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.0%
3/50 • 5 years
|
|
Nervous system disorders
Headache
|
12.0%
6/50 • 5 years
|
|
Vascular disorders
Hypertension
|
10.0%
5/50 • 5 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.0%
1/50 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • 5 years
|
|
Vascular disorders
Hypotension
|
14.0%
7/50 • 5 years
|
|
Infections and infestations
Infections and infestations
|
12.0%
6/50 • 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
16.0%
8/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
2/50 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
66.0%
33/50 • 5 years
|
|
General disorders
Pain
|
48.0%
24/50 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.0%
1/50 • 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.0%
2/50 • 5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.0%
3/50 • 5 years
|
Additional Information
Issa F Khouri, M.D. / Stem Cell Transplantation
UT MD Anderson Cancer Center
Phone: 713-745-0049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place