Stem Cell Collection With Ofatumumab - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lymphoma	Drug: Ofatumumab Drug: Ifosfamide Drug: Etoposide Drug: Mesna Drug: G-CSF Procedure: Stem Cell Collection	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Chemotherapy Plus Ofatumumab Followed by G-CSF for Mobilization of Peripheral Blood Stem Cells in Patients With Non-Hodgkin's Lymphomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Ifosfamide Mesna Etoposide Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor Ofatumumab

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Feasibility of Mobilization with Ofatumumab Plus Chemotherapy [ Time Frame: Weekly (up to 12 months) ] [ Designated as safety issue: Yes ]
Physical examination and toxicity evaluation at least weekly while the patient is hospitalized and as clinically indicated for outpatients.

Estimated Enrollment:	50
Study Start Date:	August 2011
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ofatumumab + Stem Cell Collection Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 10 gm/m2 by vein over 72 hours. 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.	Drug: Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8 Other Name: Arzera Drug: Ifosfamide 10 gm/m2 by vein over 72 hours Other Name: Ifex Drug: Etoposide 150 mg/m2 by vein over 2 hours every 12 hours for 6 doses Other Name: VePesid 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. Other Name: Mesnex Drug: G-CSF 6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis. Other Names: Filgrastim Neupogen Granulocyte colony-stimulating factor GCSF 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. Other Name: Apheresis

Arms

Assigned Interventions

Experimental: Ofatumumab + Stem Cell Collection

Ofatumumab 1000 mg by vein on Day 1 and 2000 mg by vein on Day 8. Ifosfamide 10 gm/m2 by vein over 72 hours. 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.

Drug: Ofatumumab

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

Other Name: Arzera

Drug: Ifosfamide

10 gm/m2 by vein over 72 hours

Other Name: Ifex

Drug: Etoposide

150 mg/m2 by vein over 2 hours every 12 hours for 6 doses

Other Name: VePesid

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.

Other Name: Mesnex

Drug: G-CSF

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

Other Names:

Filgrastim
Neupogen
Granulocyte colony-stimulating factor
GCSF

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.

Other Name: Apheresis

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 .

Exclusion Criteria:

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.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329900

Contacts

Contact: Issa F. Khouri, MD,BS

713-792-8750

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

GlaxoSmithKline

Investigators

Principal Investigator:

Issa F. Khouri, MD,BS

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT01329900 History of Changes
Other Study ID Numbers:	2009-0796
Study First Received:	April 4, 2011
Last Updated:	May 3, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Chemotherapy
Stem Cell Collection
Ofatumumab
Arzerra
Ifosfamide
Ifex
Etoposide

VePesid
Mesna
Mesnex
G-CSF
Filgrastim
Neupogen
Apheresis

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Mesna
Etoposide
Etoposide phosphate
Isophosphamide mustard
Ifosfamide

Lenograstim
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013