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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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01329900
First received: April 4, 2011
Last updated: March 17, 2017
Last verified: March 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Mobilization Rate [ Time Frame: Mobilization rate measured on Day 21 ]
    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. Participants who drop out before Day 21 considered failures. Method of Thall, Simon, and Estey utilized to monitor the mobilization rate.


Estimated Enrollment: 50
Actual Study Start Date: August 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (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 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.
Drug: Ofatumumab
1000 mg by vein on Day 1 and 2000 mg by vein on Day 8
Other Name: Arzera
Drug: Ifosfamide
3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.
Other Name: Ifex
Drug: Etoposide
150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically confirmed CD20 positive B-cell NHL who are candidates for autologous SCT.
  2. Patients must have PR to salvage chemotherapy.
  3. Age 18-70 years.
  4. Platelet count >/= 100,00 mm³ independent of transfusion support.
  5. Absolute neutrophil count >/= 1500/mm³.
  6. Zubrod performance status (PS) 2 or less.
  7. 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.
  8. Less than 5% marrow involvement with NHL within 4 weeks of study as defined by unilateral bone marrow aspiration and biopsy.
  9. Seronegativity for HIV, HTLV1, Hepatitis .

Exclusion Criteria:

  1. 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.)
  2. Active CNS disease.
  3. Severe concomitant medical or psychiatric illness.
  4. Lactating or breast feeding females.
  5. Serum creatinine >1.6 mg/dl.
  6. History of pelvic radiation.
  7. Fludarabine-based chemotherapy within 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Novartis
Investigators
Principal Investigator: Issa F. Khouri, MD,BS M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01329900     History of Changes
Other Study ID Numbers: 2009-0796
NCI-2011-01068 ( Registry Identifier: NCI CTRP )
Study First Received: April 4, 2011
Last Updated: March 17, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Etoposide
Etoposide phosphate
Isophosphamide mustard
Ifosfamide
Lenograstim
Antibodies, Monoclonal
Mesna
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Protective Agents

ClinicalTrials.gov processed this record on September 19, 2017