Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-06-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.

PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.

Detailed Description

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OBJECTIVES:

Primary

* Determine the antitumor activity of induction therapy comprising fludarabine phosphate with either alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplantation or alemtuzumab in patients with advanced or progressive chronic lymphocytic leukemia.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine the length of survival, event-free survival, and disease-free survival of patients treated with this regimen.
* Evaluate the relationship between different clinical and biological disease characteristics, therapeutic response, and survival.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to biological risk profile (high vs low risk).

* Group 1 (high-risk patients):

* Induction therapy: Patients receive fludarabine phosphate IV and alemtuzumab IV on days 1-3. Treatment repeats for 4 courses.

Patients with no response (no good clinical partial response, steady disease, or progressive disease) after induction therapy are removed from the study. Other patients proceed to post-induction therapy based on response to induction therapy.

* Post-induction therapy:

* Complete clinical, cytometric, and molecular response: Patients undergo peripheral blood stem cell (PBSC) mobilization with cytarabine IV twice daily on days 1-3 and filgrastim (G-CSF) followed by no further therapy.
* Response to induction therapy and evidence of residual disease (complete clinical and cytometric response with molecular evidence of disease; complete clinical response only; or good clinical partial response): Patients without an HLA familial matched donor undergo PBSC mobilization with cytarabine IV twice daily on days 1-3 and G-CSF. Patients with sufficient harvested autologous PBSCs undergo autologous PBSC transplantation (with BEAM conditioning regimen \[carmustine, etoposide, cytarabine, and melphalan\]). Patients without sufficient harvested
* PBSCs receive alemtuzumab subcutaneously (SC) weekly for 6 weeks. Patients who do not achieve molecular remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment. Patients with an HLA familial matched
* undergo reduced-intensity allogeneic stem cell transplantation (with cyclophosphamide, thiotepa, and fludarabine phosphate as conditioning regimen).

* Group 2 (low-risk patients):
* Induction therapy: Patients receive fludarabine phosphate and cyclophosphamide on days 1-3. Treatment repeats every month for 4 courses. Patients achieving at least a partial response receive 2 additional courses.

Patients achieving complete clinical response with cytometric and molecular response; complete clinical response with a cytometric response; or complete clinical response after completion of induction therapy (i.e., partial response or greater) receive no further treatment. Patients with no response or disease progression proceed to post-induction therapy.

* Post-induction therapy: Patients receive alemtuzumab SC weekly for 6 weeks. Patients who do not achieve complete remission after 6 weeks of alemtuzumab receive 6 additional weeks of treatment.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions

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Leukemia

Keywords

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stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of chronic lymphocytic leukemia (CLL)

* Advanced or progressive disease with ≥ 2 active clinical signs

PATIENT CHARACTERISTICS:

* Fertile patients must use adequate contraception
* No positive Coomb's test with signs of hemolysis
* No active infection
* No uncontrolled severe disease
* No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
* No other malignancies within the past 2 years except for adequately treated malignancies
* No significant traumatic injury within the past 4 weeks
* No coexisting medical or psychological condition that would limit study compliance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior treatment for CLL
* No major surgery within the past 4 weeks
* No prior chemotherapy

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roberto Foa, MD

Role: PRINCIPAL_INVESTIGATOR

Universita Degli Studi "La Sapeinza"

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Italy

Other Identifiers

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LLC0405

Identifier Type: OTHER

Identifier Source: secondary_id

2005-002476-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LLC0405

Identifier Type: -

Identifier Source: org_study_id

Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

High risk patientes

Fludarabine

Campath

Transplant

Campath

Low risk patients

Fludarabine

Campath

Campath

Interventions

Fludarabine

Campath

Transplant

Campath

Fludarabine

Campath

Campath

Eligibility Criteria

Inclusion Criteria

Sponsors

Gruppo Italiano Malattie EMatologiche dell'Adulto

Responsible Party

Principal Investigators

Roberto Foa, MD

Locations

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

Universita Degli Studi di Bari

Universita Cattolica del Sacro Cuore - Campobasso

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Ospedale Regionale A. Pugliese

Ospedale Civile Cosenza

Universita di Ferrara

Azienda Ospedaliera di Firenze

Ospedale San Martino

ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE

Azienda Ospedaliera Papardo

Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

Ospedale Maggiore Policlinico

Azienda Ospedaliera - Universitaria di Modena

U.O. Ematologia Clinica - Azienda USL di Pescara

Azienda Ospedaliera Bianchi Melacrino Morelli

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Ospedale Sant' Eugenio

Università Degli Studi "La Sapienza"

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Policlinico Universitario Udine

Countries

Related Links

Other Identifiers

LLC0405

2005-002476-15

LLC0405