Lymphoma, Non-HodgkinPhase 2NCT00002003
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
A Phase 2 study testing Mitoxantrone hydrochloride and Etoposide in people with Lymphoma, Non-Hodgkin and HIV Infections, run by Lederle Laboratories at 3 sites in United States.
Trial summary
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, HIV Infections
- What is being tested?
- Mitoxantrone hydrochloride and Etoposide
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Patients must have the following:
- Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
- Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
- Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
- Signed written informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Stage IE Central Nervous System lymphomas.
- Patients with the following are excluded:
- More than one previous treatment for lymphoma.
Show all 20Show fewer
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Conditions that preclude obtaining an informed consent.
- Not accessible for scheduled treatment visits or follow-up.
- Stage IE Central Nervous System (CNS) lymphomas.
- Prior Medication:
- Excluded within 2 weeks of study entry:
- Zidovudine.
- Excluded:
- Doxorubicin dosing = or > 300 mg/m2.
- Prior Treatment:
- Excluded:
- Received more than one previous treatment regimen for lymphoma.
- Required:
- Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York Univ Med Ctr
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714
About this study
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Being tested
- Mitoxantrone hydrochloride, Etoposide
- Keywords
- Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Lymphoma, Non-Hodgkin, HIV Infections, Dendritic Cell Sarcoma, Interdigitating, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone hydrochlorideDrug
EtoposideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Lederle Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002003
- Sponsor's protocol ID
- 055A
- Other IDs
- 3-100
- Status last verified
- Mar 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
- ClinicalTrials.gov ID
- NCT00002003
- Acronym / sponsor ID
- 055A
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Keywords
- Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Lederle LaboratoriesIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
- Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
- Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
- Signed written informed consent.
Key exclusion criteria (20 listed)
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Stage IE Central Nervous System lymphomas.
- More than one previous treatment for lymphoma.
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Conditions that preclude obtaining an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone hydrochloride | Drug | – |
| Etoposide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitoxantrone hydrochloride and Etoposide in people with Lymphoma, Non-Hodgkin and HIV Infections, run by Lederle Laboratories at 3 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 5 inclusion and 20 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
Where can I read the original study information?
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 24 Jun 2005.