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

NCT00816959 | Unknown Phase 3

• 1 other identifier: ASI-HDIII 0109
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hodgkin's Lymphoma

Keywords

Lymphocytic Predominant Hodgkin's Lymphoma; Late, widespread and recurrent LPHD

Outcome Measures

Primary Outcomes (1)

• The primary efficacy criterion is the response rates (RR) by Kaplan-Meier at 3,6,12, and 18 months.

  18 months

Secondary Outcomes (1)

• Additional secondary endpoint criterion is the progress free survival (PFS) by Kaplan-Meier at 18 months.

  18 months

Study Arms (2)

Arm I: R-mabHDI and ABVD

ACTIVE COMPARATOR

Drug: R-mabHDI and ABVD

Arm II: ABVD

ACTIVE COMPARATOR

Drug: ABVD

Interventions

R-mabHDI and ABVD DRUG

The subjects will 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. Also the subjects 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 be given for 6 cycles.

Also known as: R-mabHDI

Arm I: R-mabHDI and ABVD

ABVD DRUG

The subjects 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 be given for 6 cycles.

Also known as: Adriamycin, Bleomycin, Vinblastine and Dacarbazine

Arm II: ABVD

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• American Scitech International: lead
• Eli Lilly and Company: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

MedCenter

East Brunswick, New Jersey, 08816, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ABVD protocol; Doxorubicin; Bleomycin; Vinblastine; Dacarbazine

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Ratna Grewal, MD.

  American Scitech International- eCRO

  STUDY CHAIR

• Sarath Babu, MD.

  MedCenter Primary and Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ratna Grewal, MD

CONTACT

908-941-5480; rgreywal@americanscitech.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2009
• First Posted: January 6, 2009
• Study Start: July 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 20, 2011

Record last verified: 2011-07

Locations

US (1)