Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma

American Scitech International

Status and phase

Unknown

Phase 3

Conditions

Hodgkin's Lymphoma

Treatments

Drug: R-mabHDI and ABVD

Drug: ABVD

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00816959

ASI-HDIII 0109

Details and patient eligibility

About

Objective:

The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.

The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI .

The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.

Full description

The primary objective of the study is to evaluate the effect of R-mabHDI in Patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma.

A total of 1200 subjects will be recruited to the study from various centers. Enrollment period will last for up to one and half year and treatment period is for six months. Treatment will be considered a failure if the tumor size and signs of LPHD does not decrease after 3 months.

Subjects having late stage HD, widespread HD or recurrent HD fulfilling the inclusion and exclusion criteria will be recruited in this study. Females who are nursing babies or are pregnant will be excluded from the study.

All subjects will receive the drugs according to the randomization process. The eligible subjects will be randomly assigned to 1 of 2 "treatment" groups after screening. No matter which group the subjects are assigned to, the doses of the drugs will be the standard doses that are currently used to treat lymphoma.

Group 1: subjects assigned to group 1 will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will to be given for 6 cycles.

The subjects will also receive R-mabHDI intravenously, separately for about 7 hours on days 1,8,15 and 22 (once a week) of every cycle. Each cycle is 4 weeks. R-mabHDI will be given for 2 cycles.

Group 2: subjects assigned to group 2 will receive the ABVD combination intravenously for about 1 hour on day 1 and 15 of every cycle (every 2 weeks). Each cycle is 4 weeks. ABVD will to be given for 6 cycles.

Subjects in group 2 will not receive R-mabHDI .

Enrollment

1,200 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must sign the informed consent form
Patients with proven diagnosis of Lymphocytic Predominant Hodgkin's Lymphoma in late stage HD, widespread HD and recurrent HD on histology.
Patients of both gender
Patients between ages of 16 and 65 years
Patients must have bi-dimensionally measurable disease
Patients with adequate bone marrow reserve (ANC>1500/mm3 ; Platelets> 50,000/ mm3)
LVEF >/= 50% as measured by echocardiogram
Serum creatinine < 2mg/dl
Serum bilirubin < 2mg/dl; AST or ALT < 2x ULN
International Prognostic Score of >2 (Patients must have > 2 of the following risk features: Male >/= 45 years of age, Stage IV, Albumin <4, WBC >/= 15, Lymphocytes < 8% or < 600, Hb < 10.5)

Exclusion criteria

Classic Hodgkin's disease
Known HIV infection
Pregnant women and women of child bearing capacity, tests positive on a urine/blood pregnancy test, is lactating/nursing, has had three or more days of amenorrhea at the time of first dose of the treatment, is contemplating pregnancy in next six months or is not using an efficient contraceptive method.
Severe pulmonary disease as judged by the Principal Investigator including COPD and asthma
Acute infection requiring treatment with intravenous therapy
Presence of CNS lymphoma
Concomitant malignancies or previous malignancies within the last 5 years
Active Hepatitis B or C infection
Uncontrolled active infection
Concurrent prednisone or systemic steroid therapy