Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-24 @ 7:10 PM
NCT ID:
NCT00000703
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Ibuprofen.
* Standard antiemetic agents.
* Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection.
* Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase.
Exclusion Criteria
Co-existing Condition:
The following patients will be excluded from the study:
* Patients with recurrent infection that may interfere with the planned protocol.
* Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
* Patients with stage IE primary central nervous system lymphoma.
Concurrent Medication:
Excluded:
* Corticosteroids.
* Aspirin.
* Acetaminophen.
* Nonsteroidal anti-inflammatory drugs, except ibuprofen.
* Chemotherapy for infection associated with neutropenia.
* Zidovudine (AZT) for infection associated with neutropenia.
* Investigational therapies, except ganciclovir therapy for sight- or life-threatening cytomegalovirus infection.
* AZT and methotrexate will be suspended during induction therapy with ganciclovir.
The following patients will be excluded from the study:
* Patients with recurrent infection that may interfere with the planned protocol.
* Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma.
* Patients with stage IE primary central nervous system lymphoma.
Prior Medication:
Excluded:
* Zidovudine (AZT).
* Excluded within 2 weeks of study entry:
* Immunomodulating agents.
* Antiretroviral therapy prior to diagnosis of lymphoma.
Patients must demonstrate the following clinical and laboratory findings:
* Any stage of the disease, including stage I.
* Newly diagnosed, previously untreated high-grade lymphoma.
* Presence of measurable tumor parameter(s).
* Adequate hepatic, renal, and bone marrow function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT00000703
Study Brief:
Protocol Section:
NCT00000703