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Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, High-Grade

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Trial Information

Phase II Study for Treatment of Patients With Relapsed or Primary Refractory Aggressive B- Cell NHL and Anthracycline Chemotherapy Pretreatment, Who Received or Did Not Qualify for Autologous Stem Cell Transplantation.


Phase II study for treatment of patients with relapsed or primary refractory aggressive B-
cell NHL and anthracycline chemotherapy pretreatment, who received or did not qualify for
autologous stem cell transplantation. Aim is to find response rates and duration of
combination chemotherapy (bendamustine/rituximab) in patients with relapsed or refractory CD
20 positive B cell NHL.


Inclusion Criteria:



- Histologically proven high grade B-NHL (CD 20 >= 20 % positive)

- Age >= 18 years

- At least one pretreatment with anthracycline polychemotherapy +/- radiatio:

- first relapse nad contraindication for aggressive salvage therapy e.g. high dose
therapy with autologous stem cell transplantation

- second relapse (after aggressive salvage therapy)

- patient's refusal of aggressive salvage therapy in first relapse

- informed consent

Exclusion Criteria:

- untreated patients

- pretreatment with bendamustine

- primary CNS- lymphoma

- Karnofsky index < 50 (except caused by lymphoma)

- HIV positive, hepatitis B or C

- serious concurrent disease

- non-compensated heart failure (>=NYHA 3)

- non-compensated hypertension

- renal insufficiency (creatinine > 2.0 mg/dl), not related to lymphoma

- hepatic insufficiency with transaminase values greater than 3-fold of normal values
and/or bilirubin levels > 200 µmol/l, not related to lymphoma

- missing compliance respective incapability to comply (e.g.cerebral dysfunction

- pregnancy

- hematopoetic insufficiency not lymphoma related (leucocyte count <= 2500/µl,
granulocyte count <= 1000/µl, platelet count <= 80000/µl)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Principal Investigator

Martin Mohren, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Magdeburg, Department of Hematology and Oncology

Authority:

Germany: Ethics Commission

Study ID:

OSHO #73

NCT ID:

NCT00385125

Start Date:

August 2004

Completion Date:

August 2010

Related Keywords:

  • Lymphoma, High-Grade
  • relapsed
  • refractory
  • CD 20 positive
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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