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Leukeran (Chlorambucil) - Summary



LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).




LEUKERAN (chlorambucil) was first synthesized by Everett et al. It is a bifunctional alkylating agent of the nitrogen mustard type that has been found active against selected human neoplastic diseases.

LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin's disease. It is not curative in any of these disorders but may produce clinically useful palliation.

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Published Studies Related to Leukeran (Chlorambucil)

Phase III randomized study of bendamustine compared with chlorambucil in previously untreated patients with chronic lymphocytic leukemia. [2009.09.10]
PURPOSE: This randomized, open-label, parallel-group, multicenter study was designed to compare the efficacy and safety of bendamustine and chlorambucil in previously untreated patients with advanced (Binet stage B or C) chronic lymphocytic leukemia (CLL)... CONCLUSION: Bendamustine offers significantly greater efficacy than chlorambucil, and a manageable toxicity profile, when used as first-line therapy in patients with advanced CLL.

Beneficial effect of chlorambucil in steroid-dependent and cyclophosphamide-resistant minimal change nephrotic syndrome. [2009.09]
Background: Little information is available on the effect of second cytotoxic therapy in steroid-dependent children with minimal change nephrotic syndrome (MCNS). Methods: Response to second cytotoxic therapy and side effects were reviewed in 33 steroid-dependent and cyclophosphamide-resistant children with MCNS who received chlorambucil (n=11, group 1) or cyclophosphamide (n=22, group 2)...

Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. [2007.12.10]
PURPOSE: We conducted a randomized trial to evaluate the efficacy and safety of intravenous alemtuzumab compared with chlorambucil in first-line treatment of chronic lymphocytic leukemia (CLL)... CONCLUSION: As first-line treatment for patients with CLL, alemtuzumab demonstrated significantly improved PFS, time to alternative treatment, ORR and CR, and minimal residual disease-negative remissions compared with chlorambucil, with predictable and manageable toxicity.

The addition of oral idarubicin to a chlorambucil/dexamethasone combination has a significant impact on time to treatment failure but none on overall survival in patients with low grade non-Hodgkin's lymphoma: Results of the Scotland and Newcastle Lymphoma Group randomized NHL VIII trial. [2006.11]
Two hundred untreated patients with low grade NHL (KIEL), including 155 follicular NHL, were randomized to six courses of treatment with chlorambucil 20 mg m-2 for 3 days and dexamethasone 4 mg bd for 5 days (CD) vs the same regimen plus oral idarubicin 10 mg m-2 for 3 days (CID)... CID is a potential for combination with antibody therapy particularly in older patient groups.

Combined cyclophosphamide, vincristine, doxorubicin, and prednisone (CHOP) improves response rates but not survival and has lower hematologic toxicity compared with combined mitoxantrone, chlorambucil, and prednisone (MCP) in follicular and mantle cell lymphomas: results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group. [2006.09.01]
BACKGROUND: In patients with advanced-stage follicular lymphoma (FL) and mantle cell lymphoma (MCL), conventional chemotherapy remains a noncurative approach, and no major improvement in overall survival has been achieved in recent decades... CONCLUSIONS: Taking into account that, currently, chemotherapy regularly is combined with rituximab as first-line therapy for FL and MCL, the data from this study may have an impact on the type of chemotherapy to be applied in such combinations. Particularly in younger, high-risk patients who are candidates for autologous stem cell transplantation, CHOP should be preferred over MCP.

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Clinical Trials Related to Leukeran (Chlorambucil)

Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL) [Recruiting]
This is a phase I-II multicenter, open label study in previously untreated and elderly patients (> 60 years) with CLL ,which includes 2 sections:

Induction phase with Chlorambucil and Lenalidomide (CL):

- Phase 1: a non-comparative phase aimed at defining the MTD of lenalidomide given in

combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination;

- Phase 2: a non-comparative phase aimed at defining the overall response rate of

lenalidomide given at the MTD in combination with chlorambucil.

Maintenance versus clinical observation:

- A comparative phase including lenalidomide or clinical observation aimed at defining the

benefit of lenalidomide given as maintenance therapy.

Ofatumumab + Chlorambucil vs. Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia [Recruiting]
The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial) [Recruiting]
The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.

Trial Comparing Chlorambucil to Fludarabine in Patients With Advanced Waldenstr�m Macroglobulinemia [Recruiting]
Waldenström's macroglobulinaemia (WM) is a lymphoproliferative disorder characterized by a monoclonal IgM paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the cells are IgM+, IgD+, CD19+ and CD20+ but usually CD5-, CD10- and CD23-. The treatment efficacy is difficult to assess because of the lack of clear diagnostic criteria , good response criteria, and of randomized trials.

The actual treatment is Chlorambucil, an alkylating agent. A purine analogue such as Fludarabine has proven its efficacy on 30 % to 80 % as first line therapy

This study is a phase II b open, prospective, international multicenter trial (England, Dr Johnson, Dr Catovsky, Australia: Dr Seymour) promoted by the French Cooperative Group on Chronic Lymphoid Leukemia in untreated WM, or closely related disorders ( Lymphoplasmacytic lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180 patients in France. Patients will be stratified according to the lymphoproliferative disorder.

The patients will receive Chlorambucil by oral route for 10 days every 28 days (12 cycles) (8 MG/M², 6 MG/M² if patient is more than 75 years old) or Fludarabine by oral route for 5 days every 28 days (6 cycles) (40MG/M², 30 MG/M² if patient is more than 75 years old).

The primary objective is to compare the efficacy (response rate) of Chlorambucil to Fludarabine in previously untreated patients. The secondary objectives are the duration of response, the improvement of hematological parameters, the toxicity, the quality of life, the event free survival and the overall survival.

A Phase I/II, Open-label Study of Ofatumumab Added to Chlorambucil in Previously Untreated Japanese Patients With Chronic Lymphocytic Leukemia [Recruiting]
This is an open-label study to evaluate tolerability, safety, efficacy and pharmacokinetic profile of ofatumumab in combination with chlorambucil in Japanese patients with previously untreated Chronic Lymphocytic Leukemia (CLL).

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Reports of Suspected Leukeran (Chlorambucil) Side Effects

Mouth Ulceration (4)Squamous Cell Carcinoma of Skin (4)Pyrexia (3)Malaise (3)Dehydration (3)Hypophagia (3)Respiratory Tract Infection Viral (2)Ear Infection (2)Respiratory Tract Infection (2)Lymphadenopathy (1)more >>

Page last updated: 2009-10-20

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