NCT00797472

Brief Summary

120 subjects with Hodgkin's disease will be randomly divided into two groups: Group I receiving R-mabHD and Group II receiving a combination of Adriamycin,Bleomycin,Vinblastine and Dacarbazine. R-mabHD will be given once a week for eight weeks in a row. The ABVD combination will be given once every other week for 12 treatments. The hypothesis is that intervention with R-mabHD will lead to a quicker remission of Hodgkin's disease than the intervention with a combination of ABVD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
2.6 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

2.8 years

First QC Date

November 24, 2008

Last Update Submit

July 19, 2011

Conditions

Hodgkin's Disease

Keywords

Hodgkin's LymphomaR-mabHDABVD treatmentHodgkin's Disease

Outcome Measures

Primary Outcomes (1)

  • There will be a reduction in the size of the tumor after initiating treatment.

    Six months

Secondary Outcomes (1)

  • There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate.

    Eighteen months

Study Arms (2)

Arm I: R-mabHD

ACTIVE COMPARATOR

Anti-hodgkin disease agent

Drug: R-mabHD

Arm II: ABVD

ACTIVE COMPARATOR
Drug: ABVD

Interventions

R-mabHDDRUG

An intravenous infusion containing R-mabHD 375mg/m2 will be administered over a period of 3 to 8 hours every week for eight weeks in a row.

Arm I: R-mabHD
ABVDDRUG

A combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD) will be given intravenously over a period of 3 hours every other week for 12 treatments.

Also known as: Adriamycin, Bleomycin, Vinblastine, Dacarbazine
Arm II: ABVD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must sign an informed consent form
  • Must have histologically proven diagnosis of Hodgkin's lymphoma
  • Both genders and age between 18 and 65
  • Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet\>50,000/mm3)
  • Must have bidimensionally measureable disease
  • LVEF \>50% by echocardiogram
  • Serum creatinine upto one fold
  • Serum bilirubin upto one fold
  • Hepatitis B surface antigen negative
  • Hodgkin's Disease patients who relapse after radiation therapy alone or surgical treatment alone or both,or previously untreated patients with stage II bulky, III and IV.

You may not qualify if:

  • HIV positive
  • Pregnant women and women of child bearing age who are not practising adequate contraception
  • Severe pulmonary disease including COPD and asthma
  • Evidence of other malignancy except superficial nonmelanoma skin carcinoma or carcinoma in situ of the cervix
  • Nursing mothers
  • Uncontrolled active infection
  • concurrent prednisone or other systemic steroid therapy
  • Less than 4 weeks since prior radiotherapy
  • Less than 30 days since prior investigational therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raritan Bay Medical Center

Englishtown, New Jersey, 07726, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

DoxorubicinBleomycinVinblastineDacarbazine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and ProteinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesTriazenesImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ratna Grewal, M.D.

    American Scitech International

    STUDY CHAIR

  • Prem A Nandiwada, M.D.

    Raritan Bay Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

July 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)