NCT00049036

Brief Summary

This randomized phase II trial is studying how well giving combination chemotherapy together with rituximab works in treating patients with HIV-associated stage I, stage II, stage III, or stage IV non-Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more cancer cells.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2003

Longer than P75 for phase_2

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

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 22, 2011

Completed
Last Updated

May 14, 2014

Status Verified

December 1, 2012

Enrollment Period

6.2 years

First QC Date

November 12, 2002

Results QC Date

May 23, 2011

Last Update Submit

April 28, 2014

Conditions

AIDS-related Diffuse Large Cell LymphomaAIDS-related Immunoblastic Large Cell LymphomaAIDS-related Peripheral/Systemic LymphomaAIDS-related Small Noncleaved Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment

    Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma

    60 days

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive rituximab intravenously (IV) over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.

Biological: rituximabDrug: etoposideDrug: doxorubicin hydrochlorideDrug: vincristine sulfateDrug: prednisoneDrug: cyclophosphamideOther: laboratory biomarker analysis

Arm II

EXPERIMENTAL

Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.

Biological: rituximabDrug: etoposideDrug: doxorubicin hydrochlorideDrug: vincristine sulfateDrug: prednisoneOther: laboratory biomarker analysis

Interventions

rituximabBIOLOGICAL

Given IV

Also known as: IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8, Rituxan
Arm IArm II
etoposideDRUG

Given IV

Also known as: EPEG, VP-16, VP-16-213
Arm IArm II
doxorubicin hydrochlorideDRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Arm IArm II
vincristine sulfateDRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS
Arm IArm II
prednisoneDRUG

Given orally

Also known as: DeCortin, Deltra
Arm IArm II
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm IArm II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previously untreated histologically or cytologically documented B-cell non-Hodgkin's lymphoma; the following histologies are eligible: diffuse large B-cell lymphoma, high-grade large cell immunoblastic lymphoma, anaplastic large cell lymphoma, Burkitt's lymphoma, high-grade B-cell lymphoma, Burkitt-like (small non-cleaved lymphoma)
  • Tumors must be CD20 positive
  • Documented HIV infection: documentation may be serologic (ELISA, western blot), culture, or quantitative PCR or bDNA assays
  • Evaluable or measurable disease
  • Stage I and IE or Stage II-IV disease patients
  • ANC \>= 1000 cells/mm\^3
  • Platelet count \>= 75,000/mm\^3 unless cytopenias are secondary to lymphoma
  • All patients must be off colony stimulating factor therapy at least 24 hours prior to chemotherapy
  • Transaminase =\< 5 times the upper limit of normal unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir or other antiretrovirals
  • Total Bilirubin \< 2.0 unless secondary to hepatic infiltration with lymphoma or isolated hyperbilirubinemia associated with the use of indinavir or other antiretrovirals; for bilirubin \> 3.0 due to hepatic involvement the initial dose of doxorubicin will be decreased by 50% and the initial dose of vincristine will be omitted
  • Creatinine \< 2.0 unless due to lymphoma
  • KPS \>= 50 (ECOG PS 0, 1, or 2)
  • Able to give consent
  • Female patients must have a negative pregnancy test within 72 hours of entering into the study; males and females must agree to use adequate birth control if conception is possible during the study; women must avoid pregnancy and men avoid fathering children while in the study
  • Patients already receiving erythropoeitin or G-CSF are eligible
  • +2 more criteria

You may not qualify if:

  • Previous chemotherapy or radiotherapy for this lymphoma
  • Primary Central Nervous System Lymphoma (parenchymal brain or spinal cord tumor)
  • Acute active HIV-associated opportunistic infection requiring antibiotic treatment; patients with mycobacterium avium are not excluded; chronic therapy with potentially myelosuppressive agents is allowed provided that entry hematologic criteria are met
  • Concurrent malignancy (excluding in situ cervical cancer, or non-metastatic non-melanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy)
  • Previous therapy with rituximab within 12 months; patients treated with rituximab more than 12 months earlier are eligible only if it was given for indications other than the treatment of intermediate- or high-grade lymphoma (eg, low-grade lymphoma or ITP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIDS - Associated Malignancies Clinical Trials Consortium

Rockville, Maryland, 20850, United States

Location

Related Publications (2)

  • Sparano JA, Lee JY, Kaplan LD, Ramos JC, Ambinder RF, Wachsman W, Aboulafia D, Noy A, Henry DH, Ratner L, Cesarman E, Chadburn A, Mitsuyasu R. Response-adapted therapy with infusional EPOCH chemotherapy plus rituximab in HIV-associated, B-cell non-Hodgkin's lymphoma. Haematologica. 2021 Mar 1;106(3):730-735. doi: 10.3324/haematol.2019.243386.

    PMID: 32107337DERIVED

  • Sparano JA, Lee JY, Kaplan LD, Levine AM, Ramos JC, Ambinder RF, Wachsman W, Aboulafia D, Noy A, Henry DH, Von Roenn J, Dezube BJ, Remick SC, Shah MH, Leichman L, Ratner L, Cesarman E, Chadburn A, Mitsuyasu R; AIDS Malignancy Consortium. Rituximab plus concurrent infusional EPOCH chemotherapy is highly effective in HIV-associated B-cell non-Hodgkin lymphoma. Blood. 2010 Apr 15;115(15):3008-16. doi: 10.1182/blood-2009-08-231613. Epub 2009 Dec 18.

    PMID: 20023215DERIVED

MeSH Terms

Interventions

RituximabEtoposideDoxorubicinVincristinePrednisoneCyclophosphamide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesDaunorubicinAnthracyclinesNaphthacenesAminoglycosidesVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus Compounds

Results Point of Contact

Title
Jeannette Lee
Organization
AIDS Malignancy Consortium
jylee@uams.edu
501-526-6712

Study Officials

  • Joseph Sparano

    AIDS Associated Malignancies Clinical Trials Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

March 1, 2003

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 14, 2014

Results First Posted

June 22, 2011

Record last verified: 2012-12

Locations

US(1)