NCT00278161

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving rituximab and cyclophosphamide together with pegfilgrastim may be effective in treating leukemia or non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with pegfilgrastim works in treating patients with B-cell leukemia, low-grade non-Hodgkin's lymphoma, or mantle cell lymphoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started Jan 2005

Typical duration for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

November 5, 2018

Completed
Last Updated

November 5, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

January 16, 2006

Results QC Date

October 4, 2018

Last Update Submit

October 31, 2018

Conditions

LeukemiaLymphoma

Keywords

stage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiasmall lymphocytic lymphomastage I small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaB-cell chronic lymphocytic leukemiasplenic marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaWaldenstrom macroglobulinemiaprolymphocytic leukemiastage I marginal zone lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II mantle cell lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomastage III marginal zone lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarefractory chronic lymphocytic leukemiastage IV marginal zone lymphoma

Outcome Measures

Primary Outcomes (3)

  • Engraftment

    Median days to neutrophil and platelet recovery. Neutrophil recovery is defined as absolute neutrophil count \>= 500 cells per microliter; platelet recovery is defined as untransfused platelet count \>= 20 \* 10\^9 cells per liter.

    Up to 43 days

  • Non-relapse Mortality

    Number of participants who died for reasons related to protocol treatment.

    5 years

  • Event-free Survival

    Percentage of participants alive without disease relapse.

    5 years

Study Arms (1)

R-HiCy

EXPERIMENTAL

Rituximab (R) and high-dose cyclophosphamide (HiCy) with pegfilgrastim support.

Biological: PegfilgrastimBiological: RituximabDrug: Cyclophosphamide

Interventions

PegfilgrastimBIOLOGICAL

6 mg SQ 24-48 hours after last dose of cyclophosphamide.

Also known as: Neulasta
R-HiCy
RituximabBIOLOGICAL

375 mg/m\^2/day on Days 1, 4, 8, 11, 45, and 52.

Also known as: Rituxan
R-HiCy
CyclophosphamideDRUG

50 mg/kg/day on Days 15, 16, 17, and 18.

Also known as: Cytoxan, Cy, CTX
R-HiCy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * One of the following B-cell leukemias or lymphomas, as defined by World Health Organization criteria: * Chronic lymphocytic leukemia/small lymphocytic lymphoma * B-cell prolymphocytic leukemia * Lymphoplasmacytic leukemia * Marginal zone lymphoma (splenic, extranodal, or nodal) * Follicular lymphoma (grade 1 or 2) * Mantle cell lymphoma * No more than minimal (approximately 10%) morphologically identifiable cancer cells on bone marrow biopsy * When cancer cells are morphologically difficult to distinguish from normal cells, flow cytometry must show no more than 10% identifiable cancer cells * Must have received ≤ 12 months of prior cytotoxic therapy, achieving at least a partial response NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 3,000/mm\^3 * Hemoglobin ≥ 10.0 g/dL * Platelet count ≥ 75,000/mm\^3 * Serum creatinine ≤ 2.0 mg/dL * Total bilirubin ≤ 2 mg/dL unless secondary to tumor * AST or ALT \< 2 times upper limit of normal * Normal (≥ 45%) left ventricular cardiac ejection fraction (determined by echocardiogram or MUGA scan) * DLCO \> 50% predicted * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No known sensitivity to E. coli-derived products (e.g. filgrastim \[G-CSF\], insulin, asparaginase, growth hormone, or recombinant interferon alfa-2b) or any treatment study drugs * No active infections requiring oral or intravenous antibiotics * No other second malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix unless the malignancy was localized and treated or resected with \> 90% probability of cure PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior anti-CD20 therapy allowed provided patient achieved a partial or complete response * No concurrent steroids during rituximab administration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • Gladstone DE, Bolanos-Meade J, Huff CA, Zahurak M, Flinn I, Borrello I, Luznik L, Fuchs E, Kasamon Y, Matsui W, Powell J, Levitsky H, Brodsky RA, Ambinder R, Jones RJ, Swinnen LJ. High-dose cyclophosphamide and rituximab without stem cell transplant: a feasibility study for low grade B-cell, transformed and mantle cell lymphomas. Leuk Lymphoma. 2011 Nov;52(11):2076-81. doi: 10.3109/10428194.2011.594191. Epub 2011 Jul 14.

    PMID: 21756035RESULT

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularLymphoma, Mantle-CellWaldenstrom MacroglobulinemiaLeukemia, Prolymphocytic

Interventions

pegfilgrastimRituximabCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-HodgkinNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Lode Swinnen, MD
Organization
Johns Hopkins University
lswinne1@jhmi.edu
4106146398

Study Officials

  • Lode J. Swinnen, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Study Completion

July 1, 2011

Last Updated

November 5, 2018

Results First Posted

November 5, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)