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Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, Splenic Marginal Zone Lymphoma

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Trial Information

Randomized Trial Comparing the Efficacy of Chlorambucil to Fludarabine in Patients With Advanced Waldenström Macroglobulinemia,Lymphoplasmacytic Lymphoma or Splenic Marginal Zone Lymphoma


Inclusion Criteria:



Established diagnosis of Waldenström macroglobulinemia (the 2nd Workshop on Waldenstrom's
macroglobulinemia) or Lymphoplasmacytic lymphoma or Splenic Marginal Zone Lymphoma,
needing a treatment

- Life expectancy > 6 months

- Creatinine < 200 µmol/l

- SGPT and SGOT < 2x ULN

- A negative direct Coombs test

- Written informed consent

Exclusion Criteria:

- Past chemotherapy/radiotherapy/immunotherapy prior to the study for Waldenström
macroglobulinemia

- Previous malignancy less than 5 years ago except carcinoma in situ of the cervix and
non-melanoma skin cancer

- Positive HIV serology

- Active Hepatitis B or C

- Lactation/pregnancy

- Impossible good compliance with the study protocol

- Active infection not controlled

- Psychological condition hampering understanding of the study

- Transformation into large B cell lymphoma

- Peripheral neuropathy > grade II

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Patient overall response

Outcome Time Frame:

At the end of treatment whether 6 or 12 months

Safety Issue:

Yes

Principal Investigator

Véronique LEBLOND, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

French Study Group on Chronic Lymphoid Leukemia

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

WM1

NCT ID:

NCT00566332

Start Date:

June 2001

Completion Date:

December 2008

Related Keywords:

  • Waldenström Macroglobulinemia
  • Lymphoplasmacytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Lymphoplasmacytic lymphoma
  • Splenic Marginal Zone Lymphoma
  • Fludarabine
  • Chlorambucil
  • Lymphoma
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell, Marginal Zone

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