Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Follicular Lymphoma (FL).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

NCT00394836

Lymphoma, Follicular

COMPLETED PHASE2

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

NCT02082977

Cancer Neoplasms

TERMINATED PHASE1

Clinical Trial of HuMax-CD4, a New Drug to Treat Early Stage T-Cell Lymphoma in the Skin.

NCT00071071

Cutaneous T-Cell Lymphoma

COMPLETED PHASE2

Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

NCT00494780

Lymphoma, Follicular

COMPLETED PHASE2

Clinical Trial of HuMax-CD4, a New Drug to Treat Advanced Stage T-Cell Lymphoma in the Skin.

NCT00071084

Cutaneous T-Cell Lymphoma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, Follicular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HuMax-CD20

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Relapsed or refractory follicular lymphoma grade I-II
* Tumor verified to be CD20 positive
* CT scan showing demarcated lesions

Exclusion Criteria

* Previous treatment with rituximab resulting in less than partial response
* Previous radioimmunotherapy
* Previous stem cell transplantation
* Received the following treatments within 4 weeks prior to entering this study:

1. Anti-cancer therapy
2. Glucocorticosteroids unless less than 10 mg prednisolone/day
3. Radiotherapy
* Received Mitomycin C or Nitrosoureas within 6 weeks prior to entering this trial
* HIV positivity
* Hepatitis B or hepatitis C
* Uncontrolled or chronic bacterial, fungal or viral infection
* Other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
* Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
* WHO performance status of 3 or 4
* If you are participating in another trial with a different new drug 4 weeks before you enter this trial
* Current participation in any other clinical study
* Pregnant or breast-feeding women
* Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No