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

July 19, 2011 updated by: American Scitech International

Phase III Randomized, Multi-center Study to Evaluate the Effect of R-mabHDI in Patients With Lymphocytic Predominant Hodgkin's Lymphoma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

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 .

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 .

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm II: ABVD
Drug: ABVD
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.
Other Names:
  • Adriamycin, Bleomycin, Vinblastine and Dacarbazine
Active Comparator: Arm I: R-mabHDI and ABVD
Drug: R-mabHDI and ABVD

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.

Other Names:
  • R-mabHDI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional secondary endpoint criterion is the progress free survival (PFS) by Kaplan-Meier at 18 months.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Scitech International

Collaborators

Bristol-Myers Squibb
Eli Lilly and Company

Investigators

  • Study Chair: Ratna Grewal, MD., American Scitech International- eCRO
  • Principal Investigator: Sarath Babu, MD., MedCenter Primary and Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASI-HDIII 0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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