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

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ClinicalTrials.gov Identifier: NCT00797472
Recruitment Status : Unknown
Verified July 2011 by American Scitech International.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2008
Last Update Posted : July 20, 2011
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by:
American Scitech International

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.

Condition or disease Intervention/treatment Phase
Hodgkin's Disease Drug: R-mabHD Drug: ABVD Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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.
Study Start Date : July 2011
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

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 Name: Adriamycin, Bleomycin, Vinblastine, Dacarbazine

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

Secondary Outcome Measures :
  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. [ Time Frame: Eighteen months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797472

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United States, New Jersey
Raritan Bay Medical Center
Englishtown, New Jersey, United States, 07726
Contact: Prem A Nandiwada, M.D.    908-941-5480    rgreywal@americanscitech.com   
Contact: Ratna Grewal, M.D.    908-941-5480    rgreywal@americanscitech.com   
Sponsors and Collaborators
American Scitech International
Eli Lilly and Company
Bristol-Myers Squibb
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Study Chair: Ratna Grewal, M.D. American Scitech International
Principal Investigator: Prem A Nandiwada, M.D. Raritan Bay Medical Center
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Responsible Party: Dr. R. Grewal, American Scitech International
ClinicalTrials.gov Identifier: NCT00797472    
Other Study ID Numbers: ASI-HDII 1108
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011
Keywords provided by American Scitech International:
Hodgkin's Lymphoma
ABVD treatment
Hodgkin's Disease
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators