Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other OSHO #73 NCT00385125

Trial Description

Summary

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.

Further Study 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. 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.

Eligibility Criteria

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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Martin Mohren, PD

Principal Investigator

Martin Mohren, PD		Ph: 0049 231 6713266
		Email: martin.mohren@medizin.uni-magdeburg.de

Germany
	Magdeburg
	Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
		Martin Mohren, PD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00385125
Information obtained from ClinicalTrials.gov on May 27, 2008