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

Purpose

Primary Objectives:

To determine the efficacy of in vivo purging achieved by rituximab in the two groups.
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:

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.
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	Phase II

MedlinePlus related topics:

Cancer Lymphoma

ChemIDplus related topics:

Ifosfamide Etoposide Rituximab Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Estimated Enrollment:	100
Study Start Date:	January 2004

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Clinical or radiographic evidence of active CNS disease
Severe concomitant medical or psychiatric illness
Lactating or breast feeding females
Less than 3 weeks from the first day of last chemotherapy
Prior myeloablative therapy with autologous bone marrow or stem cell rescue
Serum bilirubin > 1.5 X ULN, Serum transaminases > 2XULN.
Serum creatinine >1.6 mg/dl
History of pelvic radiation
Patients should not have received more than 3 prior chemotherapy regimens (excluding radiation)
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	U.T.M.D. Anderson Cancer Center

More Information

Study ID Numbers:	ID03-0242
First Received:	July 9, 2007
Last Updated:	August 6, 2007
ClinicalTrials.gov Identifier:	NCT00499343
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

Study placed in the following topic categories:

Lymphatic Diseases

Ifosfamide

Immunoproliferative Disorders

Rituximab

Mechlorethamine

Lymphoma, small cleaved-cell, diffuse

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Etoposide phosphate

Etoposide

Lymphoma

Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Pharmacologic Actions

Neoplasms

Therapeutic Uses

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Antineoplastic Agents, Phytogenic

Alkylating Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	M.D. Anderson Cancer Center Bayer
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00499343