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AIDS Related LymphomaPhase 2NCT00001563

EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

A Phase 2 study testing Filgrastim, Rituximab and EPOCH in people with AIDS Related Lymphoma and AIDS-Associated Lymphoma, run by National Cancer Institute (NCI) at 1 site 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

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Filgrastim, Rituximab and EPOCH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
8 Jan 1997to 5 May 2005
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aggressive CD20 + NHL confirmed by Pathology, DCS.
  • HIV + serology.
  • All stages (I-IV) of disease.
  • NHL previously treated with up to two chemotherapy regimens and evaluable disease.
  • Age greater than or equal to 18 years.
  • Laboratory test: (Abnormalities are allowed if due to organ involvement by lymphoma).
Show all 12Show fewer
  • Creatinine less than or equal to 1.7.
  • Bilirubin must be less than 2.0 mg/dl, or total bilirubin less than or equal to 3.7 mg/dl with direct fraction less than or equal to 0.2 mg/dl and indirect fraction of less than or equal 3.5 mg/dl in patients for whom these abnormalities are felt to be due to protease inhibitor therapy.
  • AST and ALT less than or equal to 3 times ULN (AST and ALT less than or equal to 6 times ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation).
  • ANC greater than or equal 1000/mm(3).
  • Platelets must be greater than or equal to 75,000/mm(3) (patients with ITP platelets greater than or equal to 30,000/mm(3).
  • Signed informed consent and Durable Power of Attorney.

Who cannot join

  • Pregnancy or nursing.
  • History of clinical heart failure or symptomatic ischemic heart disease.
  • Serious underlying medical condition or infection other than HIV that would contraindicate EPOCH.
  • Concurrent anti-retroviral therapy during EPOCH therapy.
  • Primary CNS lymphoma.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

Read the detailed description

The prognosis of AIDS-related Non-Hodgkin's lymphoma is poor, especially in the relapsed setting. There is no standard treatment, and the few small studies that have been conducted have reported dismal outcomes. The purpose of this study is to pilot the use of EPOCH plus rituximab in previously treated AIDS-related lymphoma. Clinical endpoints of the study include toxicity and response. Progression-free and overall survival will be measured. Tumors will be evaluated for p53 mutations, p-16, bcl-2 expression, tumor proliferation, c-myc and EBV when possible.

Being tested
Filgrastim, Rituximab, EPOCH
Keywords
Lymphomagenesis, Molecular markers of drug resistance, Refractory, progressive, or relapsed HIV + NHL, AIDS-related NHL
Medical subject headings
Lymphoma, AIDS-Related, Lymphoma, Non-Hodgkin

What participants receive

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

  • FilgrastimBiological

    Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.

  • RituximabBiological

    EPOCH-R every 3 weeks for up to 6 cycle

  • EPOCHDrug

    EPOCH-R every 3 weeks for up to 6 cycle

Study groups in NCT00001563
Study groupRoleWhat they receive
1ExperimentalEPOCH-R every 3 weeks for up to 6 cycle
Receives: Biological: Filgrastim; Biological: Rituximab; Drug: EPOCH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of safety profile and response rates

    number and types of adverse events {AEs), as well as the number of patients who respond to the therapy {CR, PR, SD)

    Measured: End of Study

Timeline

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

  1. First posted4 Nov 1999 (estimated)
  2. Study start8 Jan 1997
  3. Primary completion5 May 2005
  4. Study completion5 May 2005

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001563
Sponsor's protocol ID
970040
Other IDs
97-C-0040
Status last verified
Jan 2022
First submitted
3 Nov 1999
Last updated
19 Jan 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kaplan LD, Abrams DI, Feigal E, McGrath M, Kahn J, Neville P, Ziegler J, Volberding PA. AIDS-associated non-Hodgkin's lymphoma in San Francisco. JAMA. 1989 Feb 3;261(5):719-24.

    PubMed 2536124

  • Sparano JA, Wiernik PH, Strack M, Leaf A, Becker NH, Sarta C, Carney D, Elkind R, Shah M, Valentine ES, et al. Infusional cyclophosphamide, doxorubicin and etoposide in HIV-related non-Hodgkin's lymphoma: a follow-up report of a highly active regimen. Leuk Lymphoma. 1994 Jul;14(3-4):263-71. doi: 10.3109/10428199409049677.

    PubMed 7950915

  • Beral V, Peterman T, Berkelman R, Jaffe H. AIDS-associated non-Hodgkin lymphoma. Lancet. 1991 Apr 6;337(8745):805-9. doi: 10.1016/0140-6736(91)92513-2.

    PubMed 1672911

  • Kurtz DM, Scherer F, Jin MC, Soo J, Craig AFM, Esfahani MS, Chabon JJ, Stehr H, Liu CL, Tibshirani R, Maeda LS, Gupta NK, Khodadoust MS, Advani RH, Levy R, Newman AM, Duhrsen U, Huttmann A, Meignan M, Casasnovas RO, Westin JR, Roschewski M, Wilson WH, Gaidano G, Rossi D, Diehn M, Alizadeh AA. Circulating Tumor DNA Measurements As Early Outcome Predictors in Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2018 Oct 1;36(28):2845-2853. doi: 10.1200/JCO.2018.78.5246. Epub 2018 Aug 20.

    PubMed 30125215

  • Dunleavy K, Little RF, Pittaluga S, Grant N, Wayne AS, Carrasquillo JA, Steinberg SM, Yarchoan R, Jaffe ES, Wilson WH. The role of tumor histogenesis, FDG-PET, and short-course EPOCH with dose-dense rituximab (SC-EPOCH-RR) in HIV-associated diffuse large B-cell lymphoma. Blood. 2010 Apr 15;115(15):3017-24. doi: 10.1182/blood-2009-11-253039. Epub 2010 Feb 3.

    PubMed 20130244

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Filgrastim, Rituximab and EPOCH in people with AIDS Related Lymphoma and AIDS-Associated Lymphoma, run by National Cancer Institute (NCI) at 1 site 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 12 inclusion and 5 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Determination of safety profile and response rates (time frame: End of Study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001563, which also lists 5 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 19 Jan 2022.

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