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

Sponsor

American Scitech International (Other)

Overall Status

Unknown status

CT.gov ID

NCT00797472

Collaborator

Eli Lilly and Company (Industry), Bristol-Myers Squibb (Industry)

120

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2011

Anticipated Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Apr 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

There will be a reduction in the size of the tumor after initiating treatment. [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. [Eighteen months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.