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

An Open-label, International, Multicenter, Dose Escalating, Phase I/II Study of HuMax-CD20 in Patients With Relapsed or Refractory Follicular Lymphoma Grade I-II

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092274

Enrollment

Registered

2004-09-27

Start date

2004-09-30

Completion date

2005-01-31

Last updated

2015-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Follicular

Keywords

Follicular Lymphoma, Non Hodgkin´s Lymphoma

Brief summary

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

Interventions

DRUGHuMax-CD20

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026