Rituximab, Combination Chemotherapy, Filgrastim (G-CSF), and Plerixafor in Treating Patients With Non-Hodgkin Lymphoma Undergoing Mobilization of Autologous Peripheral Blood Stem Cells

NCT01097057 | Completed Phase 2 Results

• 3 other identifiers: 2310.00NCI-2009-01562P30CA015704
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well giving rituximab; ifosfamide, carboplatin, and etoposide (ICE) combination chemotherapy; and filgrastim (G-CSF) together with plerixafor works in treating patients with non-Hodgkin lymphoma undergoing mobilization of autologous peripheral blood stem cells. Giving chemotherapy (ICE) with monoclonal antibodies, such as rituximab, stops the growth of cancer cells by stopping them from dividing or by killing them and helps get better autologous stem cell product. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored for future autologous transplant.

Conditions

Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (4)

• Number of Patients to Mobilize ≥5 x 10^6 CD34 Cells/kg Autologous PBSC (Efficacy)

  Number of patients who achieved ≥5 x 10\^6 CD34 cells/kg autologous PBSC collection by apheresis.

  One Month

• Number of Patients Who Achieved ≥5 x 10^6 CD34 Cells/kg in ≤4 Apheresis Days

  Number of patients to collect at least 5 x 10\^6 CD34 cells/kg in under 4 apheresis procedures.

  Up to Four Apheresis Days

• Number of Participants Requiring One or Two Apheresis Collection Days to Reach ≥5 x 10^6 CD34 Cells/kg

  Number of participants requiring one or two apheresis collection days to reach collection goal.

  Up to Four Apheresis Days

• Total Number of Participants Who Did Not Collect ≥5 x 10^6 CD34 Cells/kg in a Maximum of Four Apheresis Days

  Number of participants who did not collect ≥5 x 10\^6 CD34 cells/kg in up to four apheresis days

  Up to Four Apheresis Days

Study Arms (1)

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

EXPERIMENTAL

Patients receive rituximab IV on day 1, etoposide IV on days 2-4, carboplatin IV on day 3, and ifosfamide IV on day 3 over 24 hours. Patients also receive G-CSF SC once daily beginning on day 6 and continuing until apheresis is completed and plerixafor SC once daily for up to 4 days beginning 24 hours after recovery from nadir and continuing until apheresis is completed. Patients may undergo up to 4 apheresis procedures until the optimal number of CD34+ cells are collected.

Drug: Carboplatin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Procedure: Leukapheresis; Drug: Plerixafor; Biological: Rituximab

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Etoposide DRUG

Given IV

Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16-213, VP-16, VP-16-213

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Filgrastim BIOLOGICAL

Given SC

Also known as: Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Ifosfamide DRUG

Given IV

Also known as: Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Leukapheresis PROCEDURE

Given through catheter

Also known as: Leukocytopheresis, Therapeutic Leukopheresis

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Plerixafor DRUG

Given SC

Also known as: AMD 3100, JM-3100, Mozobil, SDZ SID 791

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Rituximab BIOLOGICAL

Given IV

Also known as: BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab Biosimilar BI 695500, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, RTXM83

Treatment (rituximab, etoposide, carboplatin, ifosfamide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CD20+ non-Hodgkin's lymphoma
• Left ventricular ejection fraction at rest \>= 50% demonstrated by multi gated acquisition scan (MUGA) or echocardiogram
• Bilirubin =\< 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 times the upper limit of normal
• Creatinine clearance (calculated creatinine clearance is permitted) \> 50 mL/min
• Signed informed consent
• Planned autologous transplant within 3 months after collection of peripheral blood stem cells (PBSCs)

You may not qualify if:

• Karnofsky performance score \< 70%
• Uncontrolled bacterial, viral, or fungal infection (currently taking medication and with progression or no clinical improvement)
• Prior other malignancies except resected basal cell carcinoma or treated cervical carcinoma or breast cancer in situ; cancer treated with curative intent \> 5 years previously will be allowed
• Pregnant or breastfeeding
• Fertile men or women unwilling to use contraceptive techniques from the time of chemo-mobilization
• Prior autologous or allogeneic hematopoietic stem cell transplant (HSCT)
• Human immunodeficiency virus (HIV) positive
• Plan to be treated on another investigational therapy within 4 weeks of enrolling on this study
• Hepatitis B carriers

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Carboplatin; Etoposide; Filgrastim; Granulocyte Colony-Stimulating Factor; Ifosfamide; Leukapheresis; plerixafor; ferric pyrophosphate; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Leona A. Holmberg
• Organization: Fred Hutchinson Cancer Research Center

lholmber@fredhutch.org

206-667-6447

Study Officials

• Leona Holmberg

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: November 9, 2010
• Primary Completion: September 1, 2013
• Study Completion: December 26, 2017
• Last Updated: January 23, 2018
• Results First Posted: July 2, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)