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Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Immunocytoma/Morbus Waldenström, B-Cell Non-Hodgkin's Lymphoma, B-Cell Chronic Lymphocytic Leukemia

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Trial Information

Phase II Study to Evaluate the Safety and Efficacy of the Treatment With Pentostatin, Cyclophosphamide and Rituximab Followed by Rituximab Maintenance in Previously Untreated and Relapsed Patients With Immunocytoma/Morbus Waldenström, B-CLL and Other Indolent B-Cell Lymphomas


Inclusion Criteria:



- confirmed first diagnosis of or relapsed CD20-positive Immunocytoma, B-CLL or other
indolent B-NHL

- therapy-requiring CLL defined as: Binet stage C or Binet B combined with occurence of
B-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass

- therapy-requiring Immunocytoma as defined by the Consensus Panel Recommendations from
the Second International Workshop on Waldenström´s Macroglobulinemia, 2003)

- age > 18 years

- anticipated life expectancy > 6 months

- ECOG 0-3

- no significant comorbidities

- signed informed consent

- efficient method of contraception during time of therapy (men and women)

Exclusion Criteria:

- age < 18 years

- CD20 negativity

- significant comorbidities interfering with therapy as required by the protocol

- history of HIV infection or active hepatitis

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy: overall response rate

Outcome Time Frame:

after 6 months and after 36 months

Safety Issue:

Yes

Principal Investigator

Anthony D Ho, Ph.D., Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director of Department

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

L-278/2004

NCT ID:

NCT00927797

Start Date:

February 2005

Completion Date:

January 2012

Related Keywords:

  • Immunocytoma/Morbus Waldenström
  • B-cell Non-Hodgkin's Lymphoma
  • B-cell Chronic Lymphocytic Leukemia
  • immunochemotherapy
  • Pentostatin
  • Cyclophosphamide
  • Rituximab
  • Maintenance
  • indolent B-NHL
  • B-CLL
  • B-NHL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

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