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Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Randomized Trial of CHOP Chemotherapy With or Without Rituximab (Chimeric Anti-CD20 Antibody) for HIV-Associated Non-Hodgkin's Lymphoma


OBJECTIVES:

I. Compare the efficacy of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)
with or without rituximab in patients with previously untreated HIV-associated non-Hodgkin's
lymphoma.

II. Determine the efficacy of rituximab as maintenance therapy following remission induction
with CHOP in these patients.

III. Determine the effect of rituximab on the immune system and HIV viral load in these
patients.

IV. Determine the relationship between EBV load and the presence of EBV in lymphoma tumor
cells of these patients.

V. Compare the effect of CHOP with or without rituximab on EBV load in these patients.

OUTLINE: This is a randomized, multicenter study.

Patients are stratified by extent of disease (stage I/II vs III/IV). Patients are randomized
to 1 of 2 treatment arms:

Arm I: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 3 and
oral prednisone on days 3-7. Patients receive rituximab on day 1. Treatment repeats every 3
weeks for a minimum of 4 courses or 2 courses beyond complete response in the absence of
disease progression or unacceptable toxicity. Patients with stage I, stage IE (including
bulky), or nonbulky stage II or IIE disease receive 3 courses of chemotherapy with rituximab
followed by radiotherapy beginning 3 weeks after completion of the third course. Patients
who achieve partial response for a minimum of 28 days or complete response receive
maintenance rituximab IV beginning on day 28 of the final course of chemotherapy.
Maintenance rituximab treatment repeats every 4 weeks for 3 courses.

Arm II: Patients receive cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1
and oral prednisone on days 1-5. Treatment repeats every 3 weeks for a minimum of 4 courses
or 2 courses beyond complete response. Patients with stage I, stage IE (including bulky), or
nonbulky stage II or IIE disease receive 3 courses of chemotherapy. Patients receive
radiotherapy beginning 3 weeks after completion of the third course of chemotherapy.

Both arms: Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and
continuing through day 13 of each chemotherapy course or until blood counts recover.

Patients are followed every 4 weeks for 1 year and then every 2 months until death.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma,
including:

- Diffuse large B cell lymphoma

- Intermediate grade diffuse large cell lymphoma

- High grade large cell immunoblastic lymphoma

- Burkitt's lymphoma

- High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma)

- No primary CNS lymphoma (parenchymal brain or spinal cord tumor)

- Evaluable disease HIV documentation may be serologic (ELISA or western blot),
culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than
50% cells express CD20)

- 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:

- Age: Over 18

- Performance status: Karnofsky 70-100%

- Absolute neutrophil count greater than 1,000/mm3*

- Platelet count greater than 75,000/mm3*

* Unless cytopenias are secondary to lymphoma

- Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma
or isolated hyperbilirubinemia associated with the use of indinavir)

- SGOT or SGPT less than 7 times upper limit of normal

- Creatinine less than 2.0 mg/dL (unless due to lymphoma)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No acute, active HIV-associated opportunistic infection requiring antibiotics

- Mycobacterium avium complex allowed

- No concurrent malignancy except carcinoma in situ of the cervix, nonmetastatic
nonmelanomatous skin cancer, or Kaposi's sarcoma not requiring systemic chemotherapy

PRIOR CONCURRENT THERAPY:

- Prior or concurrent epoetin alfa or filgrastim (G-CSF) allowed

- No prior colony stimulating factor therapy within 24 hours prior to chemotherapy

- No prior chemotherapy for HIV-associated non-Hodgkin's lymphoma

- At least 1 year since prior cyclophosphamide or doxorubicin

- No prior radiotherapy for HIV-associated non-Hodgkin's lymphoma

- Chronic therapy with myelosuppressive agents allowed

- Concurrent antiretroviral therapy, antifungal medications, and antibiotics allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lawrence D. Kaplan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02279

NCT ID:

NCT00003595

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • childhood Burkitt lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related diffuse large cell lymphoma
  • AIDS-related immunoblastic large cell lymphoma
  • AIDS-related small noncleaved cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Mount Sinai School of MedicineNew York, New York  10029
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
San Francisco General Hospital Medical CenterSan Francisco, California  94110
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University Hospital/New Jersey Cancer CenterNewark, New Jersey  07103