G-CSF Versus G-CSF Plus GM-CSF for Stem Cell Mobilization in NHL Patients

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00499343
First received: July 9, 2007
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Primary Objectives:

  1. To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
  2. To determine the number of apheresis procedures, total stem cell yield/kg patient body weight and the toxicity profile in the two groups.

Secondary Objectives:

  1. To determine the degree of expression of various adhesion molecules in the 2 groups and correlate with time to engraftment of neutrophils, platelets, and red blood cells, efficacy of stem cell mobilization and purging.
  2. To determine the incidence of disease progression/relapse at 12 months in the two groups.

Condition Intervention Phase
Lymphoma
Drug: Etoposide
Drug: G-CSF
Drug: GM-CSF
Drug: Isophosphamide
Drug: Rituximab
Procedure: Apheresis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Chemotherapy Followed by G-CSF Alone Versus G-CSF Plus GM-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:
  • CD34+ Cells/kg in Blood Stem Cells [ Time Frame: The process of stem cell collections take about 4 hours, 1-6 sessions may be needed. ] [ Designated as safety issue: Yes ]
    After blood counts return to normal, stem cell collection (takes approximately 4 hours) up to 6 sessions.


Enrollment: 84
Study Start Date: January 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab + Ifosfamide + Etoposide + 2 Growth Factors
Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
Drug: Etoposide
150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.
Other Name: Vepesid
Drug: G-CSF
Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
Other Names:
  • Filgrastim
  • Neupogen
Drug: GM-CSF
250 mcg/m^2 injection given every evening till the completion of apheresis.
Other Names:
  • Sargramostim
  • Leukine
Drug: Isophosphamide
10 g/m^2 given intravenously continuous infusion over 72 hours.
Other Names:
  • ifosfamide
  • Ifex
Drug: Rituximab
Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.
Other Name: Rituxan
Procedure: Apheresis
Peripheral blood stem cell collection.
Experimental: Rituximab + Ifosfamide + Etoposide + 1 Growth Factor
Growth Factor = granulocyte-colony stimulating factor (G-CSF)
Drug: Etoposide
150 mg/m^2 given intravenously over 2 hours every 12 hours x 6 doses.
Other Name: Vepesid
Drug: G-CSF
Starting dose on day +6 at 6 mcg/kg injection every 12 hours until completion of apheresis.
Other Names:
  • Filgrastim
  • Neupogen
Drug: Isophosphamide
10 g/m^2 given intravenously continuous infusion over 72 hours.
Other Names:
  • ifosfamide
  • Ifex
Drug: Rituximab
Days +1 (375 mg/m^2) and +8 (1000 mg/m^2) given intravenously.
Other Name: Rituxan
Procedure: Apheresis
Peripheral blood stem cell collection.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Patients with histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma who are candidates for autologous stem cell transplantation.
  2. Age up to 70 years
  3. Platelet count > 100,000 mm3, independent of transfusion support
  4. Absolute neutrophil count (ANC) > 1500/mm3
  5. Zubrod performance status of 2 or less.
  6. Negative pregnancy test in women
  7. Less than 10% marrow involvement with lymphoma within 4 weeks of study enrollment as defined by bilateral bone marrow aspirations and biopsies.
  8. Should be seronegative for HIV, HTLV, hepatitis B surface antigen, hepatitis C antibody.

Exclusion Criteria:

  1. Clinical or radiographic evidence of active CNS disease
  2. Severe concomitant medical or psychiatric illness
  3. Lactating or breast feeding females
  4. Less than 3 weeks from the first day of last chemotherapy
  5. Prior myeloablative therapy with autologous bone marrow or stem cell rescue
  6. Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.
  7. Serum creatinine >1.6 mg/dl
  8. History of pelvic radiation
  9. Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)
  10. Patients should not have received more than 6 cycles of fludarabine therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499343

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer
Investigators
Principal Investigator: Chitra M. Hosing, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00499343     History of Changes
Other Study ID Numbers: ID03-0242
Study First Received: July 9, 2007
Results First Received: March 3, 2009
Last Updated: June 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Non-Hodgkin's Lymphoma
Lymphoma
Etoposide
G-CSF
GM-CSF
Isophosphamide
Rituximab
Ifosfamide
Sargramostim
Leukine
Filgrastim
Neupogen
Apheresis
Stem Cell Collection

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
Rituximab
Ifosfamide
Mitogens
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 14, 2014