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AzTrials

Lymphoma, Non-HodgkinPhase 3NCT00000658

A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin's Lymphoma

A Phase 3 study testing Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL). HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin, HIV Infections
What is being tested?
Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride
How many people
250 participants
Where
22 sitesUnited States
Study dates
Start not givento Feb 1996
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Required:
  • PCP prophylaxis with Bactrim, aerosolized pentamidine, or dapsone.
  • Allowed:
  • ddI, except when patient is also taking allopurinol.
  • Patients must have the following:
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  • Diagnosis of HIV seropositivity and non-Hodgkin's lymphoma.
  • Ability to give informed consent and willingness to comply with all procedures and visit schedule.
  • If between ages of 12 and 18 must receive care under direct supervision of a pediatric oncologist, and have consent of parent, guardian, or person with power of attorney.
  • Participation in clinical trials of other antiretroviral agents is at the discretion of the investigator and individual patient.

Who cannot join

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
  • Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
  • Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
  • Primary central nervous system lymphoma.
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  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT) or any antiretroviral agent unless allowed by investigator. ddI is allowed except when also taking allopurinol.
  • Systemic myelosuppressive drugs, including trimethoprim/sulfamethoxazole (T/S), pyrimethamine/sulfa, or ganciclovir.
  • -
  • Patients with the following are excluded:
  • Active opportunistic infection, excluding Mycobacterium avium complex, requiring antibiotic therapy.
  • Another prior or current malignancy, excepting curatively treated cervical or basal cell carcinoma.
  • Kaposi's sarcoma if rapidly progressive, with visceral involvement, or causing peripheral edema.
  • Primary central nervous system lymphoma.
  • Prior Medication:
  • Excluded:
  • Immunomodulating agents within 2 weeks of study entry.
  • Prior Treatment:
  • Excluded:
  • Chemotherapy.
  • Radiation therapy as outlined in protocol.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

United States22 sites

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80262

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland

  • Beth Israel Deaconess Med. Ctr., ACTG CRS

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Bmc Actg Crs

    Boston, Massachusetts

  • SUNY - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, 14215

  • Unc Aids Crs

    Chapel Hill, North Carolina, 275997215

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60612

  • Case CRS

    Cleveland, Ohio

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 432101228

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 462025250

  • USC CRS

    Los Angeles, California, 900331079

  • UCLA CARE Center CRS

    Los Angeles, California, 90095

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York, 02215

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Memorial Sloan-Kettering Cancer Ctr.

    New York, New York, 10021

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • Pitt CRS

    Pittsburgh, Pennsylvania, 15213

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Ucsf Aids Crs

    San Francisco, California, 941102859

  • Washington U CRS

    St Louis, Missouri

Other trials in United States

About this study

To determine the impact of dose intensity on tumor response and survival in patients with HIV-associated non-Hodgkin's lymphoma (NHL).

HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.

Read the detailed description

HIV-infected patients are at increased risk for developing intermediate and high-grade NHL. While combination chemotherapy for aggressive B-cell NHL in the absence of immunodeficiency is highly effective, the outcome of therapy for patients with AIDS-associated NHL has been disappointing. Treatment is frequently complicated by the occurrence of multiple opportunistic infections, as well as the presence of poor bone marrow reserve, making the administration of standard doses of chemotherapy difficult. A recent study was completed using a low-dose modification of the standard mBACOD (cyclophosphamide, doxorubicin, vincristine, bleomycin, dexamethasone, methotrexate ) treatment. A 46 percent response rate was observed in patients treated with this combination of chemotherapeutic agents, with a number of durable remissions and reduced toxicity when compared to previous experience with more standard treatments. A subsequent study showed similar effectiveness using a lower dose of methotrexate administered on day 15. It is hoped that the use of sargramostim (granulocyte-macrophage colony-stimulating factor; GM-CSF) will improve bone marrow function and allow for administration of a higher dose of chemotherapy.

Patients are randomized to one of two treatment groups. Patients are stratified for (1) presence or absence of a prior AIDS diagnosis, (2) Karnofsky performance status of 70 or greater and lower than 70. Treatment includes prophylaxis for meningeal lymphoma and Pneumocystis carinii pneumonia. Patients on low-dose mBACOD who experience neutropenia may be given rGM-CSF until the absolute neutrophil count improves. AZT may be initiated at the completion of chemotherapy for all patients in complete remission at that time.

PER AMENDMENT 5/30/95: This trial was closed to accrual on 11/7/94 on the recommendation of the Data and Safety Monitoring Board (DSMB), because the non-significant difference in survival between the 2 treatment groups was not expected to change with further enrollment.

Being tested
Bleomycin sulfate, Vincristine sulfate, Doxorubicin hydrochloride, Cyclophosphamide, Allopurinol
Keywords
M-BACOD protocol, Granulocyte-Macrophage Colony-Stimulating Factor, Acquired Immunodeficiency Syndrome, Allopurinol, Antineoplastic Agents, Combined
Medical subject headings
Lymphoma, Non-Hodgkin, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionFeb 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Masking
None (open label)
Enrolment
250 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000658
Sponsor's protocol ID
ACTG 142
Other IDs
11117
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • Kaplan LD, Straus DJ, Testa MA, Von Roenn J, Dezube BJ, Cooley TP, Herndier B, Northfelt DW, Huang J, Tulpule A, Levine AM. Low-dose compared with standard-dose m-BACOD chemotherapy for non-Hodgkin's lymphoma associated with human immunodeficiency virus infection. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group. N Engl J Med. 1997 Jun 5;336(23):1641-8. doi: 10.1056/NEJM199706053362304.

    PubMed 9171066

  • Kaplan L, et al. Randomized trial of standard dose mBACOD with GM-CSF vs reduced dose mBACOD for systemic HIV-associated lymphoma: ACTG 142. Proc Annu Meet Am Assoc Cancer Res. 1995;14:A818

  • Straus DJ, Huang J, Testa MA, Levine AM, Kaplan LD. Prognostic factors in the treatment of human immunodeficiency virus-associated non-Hodgkin's lymphoma: analysis of AIDS Clinical Trials Group protocol 142--low-dose versus standard-dose m-BACOD plus granulocyte-macrophage colony-stimulating factor. National Institute of Allergy and Infectious Diseases. J Clin Oncol. 1998 Nov;16(11):3601-6. doi: 10.1200/JCO.1998.16.11.3601.

    PubMed 9817281

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bleomycin sulfate, Vincristine sulfate and Doxorubicin hydrochloride in people with Lymphoma, Non-Hodgkin and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000658, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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