EPOCH Chemotherapy +/- IL-12 for Previously Untreated and EPOCH Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma
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ClinicalTrials.gov Identifier: NCT00001563 |
Recruitment Status
:
Completed
First Posted
: November 4, 1999
Last Update Posted
: February 23, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AIDS Related Lymphoma | Biological: Filgrastim Biological: Rituximab Drug: EPOCH | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | EPOCH Chemotherapy Plus Rituximab for Previously Treated Patients With AIDS-Associated Lymphoma |
Study Start Date : | December 12, 1996 |
Actual Primary Completion Date : | May 5, 2005 |
Actual Study Completion Date : | May 5, 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
EPOCH-R every 3 weeks for up to 6 cycle
|
Biological: Filgrastim
Filgrastim after EPOCH-R from Day 6 for 10 days every cycle.
Biological: Rituximab
EPOCH-R every 3 weeks for up to 6 cycle
Drug: EPOCH
EPOCH-R every 3 weeks for up to 6 cycle
|
- Determination of safety profile and response rates [ Time Frame: End of Study ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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).
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.
EXCLUSION CRITERIA:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001563
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Wyndham H Wilson, M.D. | National Cancer Institute (NCI) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00001563 History of Changes |
Obsolete Identifiers: | NCT00019253 |
Other Study ID Numbers: |
970040 97-C-0040 |
First Posted: | November 4, 1999 Key Record Dates |
Last Update Posted: | February 23, 2018 |
Last Verified: | July 15, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Lymphomagenesis Molecular markers of drug resistance Refractory, progressive, or relapsed HIV + NHL AIDS-related NHL |
Additional relevant MeSH terms:
Lymphoma Lymphoma, AIDS-Related Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell |
Lymphoma, Non-Hodgkin Rituximab Lenograstim Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Adjuvants, Immunologic |