Trials Sponsors Conditions Drugs Pricing

Conditions

Epstein Barr Virus Associated Hodgkin's Lymphoma Epstein Barr Virus Associated Non Hodgkin's Lymphoma Post-Transplant Lymphoproliferative Disease

Keywords

EBV+NHLHLNon Hodgkin's LymphomaHodgkin's LymphomaEpstein Barr VirusEpstein Barr Virus Associated Non Hodgkin's LymphomaEpstein Barr Virus Associated Hodgkin's LymphomaPost-Transplant Lymphoproliferative Disease

Outcome Measures

Primary Outcomes (1)

Rate of Complete Response to Protocol Therapy
Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include: * Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL); * All lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for nodes \> 1.5 cm before therapy); * Previously involved nodes that were 1.1 to 1.5 cm in their greatest transverse diameter (GTD) before treatment must have decreased to ≤ 1 cm in their GTD after treatment, or by more than 75% bin the sum of the products of the greatest diameters (SPD); * No new sites of disease.
About 21 days

Secondary Outcomes (9)

One-year Rate of Overall Survival
12 months

Study Arms (1)

Chemotherapy + Antiviral-Based Therapy

EXPERIMENTAL

Combination Chemotherapy for up to six (6) 21-day cycles and Antiviral-Based Therapy: * Chemotherapy: Up to 6 cycles, 21 days each: * Doxorubicin: 20 mg/m2 intravenously (IV) on Day 1 per study protocol; * Rituximab: 375mg/m2 (optional) IV on Day 1 per study protocol; * Methotrexate: 3.5 gm/m2 IV on Day 2 per study protocol; * Leucovorin: 10 mg/m2 IV starting approximately 24 hours after start of Methotrexate infusion, and then 25 mg orally every 6 hours for at least 10 doses per study protocol; * Antiviral-Based Therapy * Zidovudine: Starting 750 mg/m2 IV on Day 2, then 1200 mg orally twice daily for 10 doses per study protocol; * Hydroxyurea: 1,000 mg orally twice daily starting Day 2 for a total of 10 doses per study protocol.

Drug: DoxorubicinDrug: MethotrexateDrug: LeucovorinBiological: HydroxyureaDrug: ZidovudineDrug: Rituximab

Interventions

DoxorubicinDrug

Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines

Also known as: Adriamycin

Chemotherapy + Antiviral-Based Therapy

MethotrexateDrug

Methotrexate administered starting on Day 2, per study protocol.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Any stage, histologically or cytologically documented intermediate to high grade relapsed or refractory EBV+ non-Hodgkin's (NHL) or Hodgkin's lymphoma (HL), or any treated or untreated patients with EBV+ lymphoma involving CNS. Patients with relapsed or refractory monomorphic (monoclonal) post-transplant lymphoproliferative disease (PTLD) are also eligible.

Sponsors & Collaborators

University of Miami
Otherlead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27999, United States

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHodgkin DiseaseEpstein-Barr Virus Infections

Interventions

DoxorubicinMethotrexatemerphosLeucovorinHydroxyureaZidovudineRituximab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative Disorders

Results Point of Contact

Title: Juan C. Ramos MD
Organization: University of Miami

Study Officials

Juan Carlos Ramos, MD
University of Miami
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor of Clinical

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 17, 2013

Study Start

April 21, 2009

Actual (reported)

You may not qualify if:

Concurrent active malignancies, with the exception of in situ carcinoma of the cervix, non-metastatic, non-melanomatous skin cancer, or Kaposi sarcoma not requiring systemic chemotherapy.
Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe, uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiograph evidence of acute ischemic or active conduction system abnormalities.
Left Ventricular Ejection Fraction (LVEF) that is less than the lower institutional limits of normal as assessed by Multiple Gated Acquisition (MUGA) scan or echocardiogram within 6 weeks prior to registration.
Subjects with viral hepatitis who do not meet the criteria listed on (8.2) will be not be eligible. All patients who present with acute hepatitis B including those with normal transaminases who are HBsAg+ and IgM + for hepatitis core antigen will not be eligible. Subjects who are Hepatitis B core antibody positive are eligible only if they start or are on prophylactic therapy. A hepatitis B viral load should be confirmed negative on all patients who are hepatitis B core antibody positive, but hepatitis B antigen negative. Patients refusing to take any anti-hepatitis B therapy during study will also be excluded. Patients diagnosed with Hepatitis C are eligible if they meet criteria listed on (8.2).
Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
Patients may not be receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patients with mycobacterium avium will not be excluded.
Pregnant or breast-feeding women.

Study Stopped

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Chemotherapy + Antiviral-Based Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations

Study Stopped

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Chemotherapy + Antiviral-Based Therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations