This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by American Scitech International.
Recruitment status was:  Not yet recruiting
ImClone LLC
Bristol-Myers Squibb
Information provided by:
American Scitech International Identifier:
First received: November 24, 2008
Last updated: July 19, 2011
Last verified: July 2011
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.

Condition Intervention Phase
Hodgkin's Disease Drug: R-mabHD Drug: ABVD Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by American Scitech International:

Primary Outcome Measures:
  • There will be a reduction in the size of the tumor after initiating treatment. [ Time Frame: Six months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Adriamycin, Bleomycin, Vinblastine, Dacarbazine

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00797472

United States, New Jersey
Raritan Bay Medical Center Not yet recruiting
Englishtown, New Jersey, United States, 07726
Contact: Prem A Nandiwada, M.D.    908-941-5480   
Contact: Ratna Grewal, M.D.    908-941-5480   
Sponsors and Collaborators
American Scitech International
ImClone LLC
Bristol-Myers Squibb
Study Chair: Ratna Grewal, M.D. American Scitech International
Principal Investigator: Prem A Nandiwada, M.D. Raritan Bay Medical Center
  More Information

Responsible Party: Dr. R. Grewal, American Scitech International Identifier: NCT00797472     History of Changes
Other Study ID Numbers: ASI-HDII 1108
Study First Received: November 24, 2008
Last Updated: July 19, 2011

Keywords provided by American Scitech International:
Hodgkin's Lymphoma
ABVD treatment
Hodgkin's Disease

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on September 19, 2017