Study Comparing R-mabHD and a Combination of ABVD in Hodgkin's Disease

July 19, 2011 updated by: American Scitech International

A Phase II Open Label, Multicenter, Randomized, Parallel Study Comparing the Efficacy of R-mabHD Alone and a Combination of Adriamycin, Bleomycin, Vinblastine and Dacarbazine (ABVD)in Treating Patients With Hodgkin's Disease.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to compare the efficacy of R-mabHD with a combination therapy of Adriamycin, Bleomycin,Vinblastine and Dacarbazine (ABVD) in bringing about remission of Hodgkin's lymphoma and reduction in tumor size.

Primary Study Endpoint: Primary efficacy criterion is percentage of patients achieving a functional score of 1.

Efficacy evaluation is based on assessment of functional score. At the end of six months, a functional assessment of the tumor will be undertaken to record the score as follows:

Score 1: >/= 50% reduction in size of tumor Score 2: < 50% reduction in size of tumor.

Secondary Study Endpoint: Additional secondary endpoint is the average time to achieve 50% reduction in size of tumor.

120 subjects with Hodgkin's Disease will be divided randomly into two groups. 60 subjects (Group I)will receive R-mabHD by intravenous infusion in a dose of 375mg/m2 once a week for eight weeks in a row. The other half (Group II) will receive a combination of intravenous Adriamycin, Bleomycin, Vinblastine and Dacarbazine every other week for 12 treatments. Enrollment period will be three years and subjects from both genders will be accepted. Subjects should be between the ages of 18 and 65. No healthy volunteers will be accepted. Females who are nursing babies or are pregnant will be excluded from the study. Subjects will be evaluated every month for the first six months and then at one year and then at eighteen months after the baseline visit one.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must sign an informed consent form
  2. Must have histologically proven diagnosis of Hodgkin's lymphoma
  3. Both genders and age between 18 and 65
  4. Must have adequate bone marrow reserve (ANC.1500/mm3, Platelet>50,000/mm3)
  5. Must have bidimensionally measureable disease
  6. LVEF >50% by echocardiogram
  7. Serum creatinine upto one fold
  8. Serum bilirubin upto one fold
  9. Hepatitis B surface antigen negative
  10. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I: R-mabHD
Anti-hodgkin disease agent
Drug: R-mabHD
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.
Active Comparator: Arm II: ABVD
Drug: ABVD
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.
Other Names:
  • Adriamycin, Bleomycin, Vinblastine, Dacarbazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
There will be a reduction in the size of the tumor after initiating treatment.
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
There will be an improvement in the general condition of the patient and it will be possible to estimate the event free survival rate.
Time Frame: Eighteen months
Eighteen months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Scitech International

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company

Investigators

  • Study Chair: Ratna Grewal, M.D., American Scitech International
  • Principal Investigator: Prem A Nandiwada, M.D., Raritan Bay Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-HDII 1108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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