Know Cancer

or
forgot password

Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma

Thank you

Trial Information

Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas


Inclusion Criteria:



- Patients with histological verified CD20-positive B-Cell-Lymphomas of the following
entities:

- Follicular lymphoma grade 1 and 2

- Immunocytoma and lymphoplasmocytic lymphoma

- Marginal zone lymphoma, nodal and generalised

- Mantle cell lymphoma

- lymphocytic lymphoma (CLL without leucaemic characteristics)

- non-specified/classified lymphomas of low malignancy

- Recurrent disease (remission duration minimum 3 months), independent of type or
quantity of prior therapies, except of Rituximab containing regimens, or if remission
duration is > 1 year after Rituximab containing regimen, or refractory to prior
therapy (progression under therapy or during 3 months after completion), except
refractory disease to purin analogs or Bendamustine

- Need for therapy, except mantle cell lymphomas

- Stadium II (bulky disease, 7.5 cm), II or IV

- Written informed consent

- Performance status WHO 0-2

- Histology not older than 6 months

Exclusion Criteria:

- Patients not establishing all above mentioned prerequisites

- Option of a primary, potentially curative radiation therapy

- Patients refractory to Rituximab containing regimens

- Comorbidities excluding a study conform therapy:

heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe
functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or
kidney (creatinine > 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma

- Active auto immunohemolytic anemia (AIHA)

- HIV positive patients

- Active hepatitis infection

- Severe psychiatric diseases

- No compliance or non-compliance to be expected

- Pregnant or breast feeding women

- Anamnestic malignancies or secondary malignancies, not proven

- Cured/curable by surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event Free Survival

Outcome Description:

From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year

Outcome Time Frame:

Observation till event or death, minimum 1 year

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NHL 2-2003

NCT ID:

NCT01456351

Start Date:

September 2003

Completion Date:

December 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Event free survival
  • Remission rates
  • Toxicity
  • Overall survival
  • Efficiency costs
  • Recurrent low grade
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location