NCT00007852

Brief Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2 lymphoma

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

September 1, 2000

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 12, 2004

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

January 6, 2001

Last Update Submit

August 29, 2023

Conditions

Lymphoma

Keywords

recurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • 100 day (complete + partial) response rate

    The primary endpoint for this study is 100 day (complete + partial) response rate

    100 days

Study Arms (1)

Arm I

EXPERIMENTAL

Rituxan and BEAM with autologous stem cell transplant

Biological: rituximabDrug: carmustineDrug: cytarabineDrug: etoposideDrug: melphalanProcedure: autologous hematopoietic stem cell transplantation

Interventions

rituximabBIOLOGICAL

Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.

Also known as: Rituxan
Arm I
carmustineDRUG

BCNU 300 mg/M2 IV day -6

Also known as: BCNU
Arm I
cytarabineDRUG

100 mg/m2 on days -5 through -2

Also known as: BEAM chemotherapy regimen
Arm I
etoposideDRUG

100mg/M2 BID on days -5 through -2

Also known as: BEAM chemotherapy regimen
Arm I
melphalanDRUG

140 mg/m2 IV on day -1

Also known as: BEAM chemotherapy regimen
Arm I
autologous hematopoietic stem cell transplantationPROCEDURE

Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Arm I

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma
  • Transplantation candidate
  • Primary induction failure
  • Chemotherapy refractory disease
  • Received at least 3 prior chemotherapy regimens or diagnosis of mantle cell lymphoma
  • Age 19 and over
  • Performance status: WHO 0-2
  • Life expectancy at least 6 months
  • Absolute neutrophil count at least 1,000/mm3 (unless due to lymphomatous involvement of the marrow)
  • Platelet count more than 50,000/mm3 (unless due to lymphomatous involvement of the marrow)
  • Hemoglobin more than 9.0 g/dL (unless due to lymphomatous involvement of the marrow)
  • Fertile patients must use effective contraception
  • Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed

You may not qualify if:

  • No other concurrent chemotherapy
  • No concurrent corticosteroids except for transient control or prevention of nausea or vomiting
  • No concurrent external beam radiotherapy during transplantation therapy
  • No other concurrent antitumoral or investigational agents
  • No history of T-cell lymphoma
  • No relapse or progression after rituximab therapy within 3 months before transplantation
  • No serious disease or condition that would preclude study
  • Not pregnant or nursing/negative pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

RituximabCarmustineCytarabineEtoposideMelphalan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Julie M Vose, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

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 6, 2001

First Posted

February 12, 2004

Study Start

September 1, 2000

Primary Completion

January 1, 2002

Study Completion

January 1, 2011

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)