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

NCT00462332 | Completed Phase 2 Results

• 2 other identifiers: LLC04052005-002476-15
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 23

Brief Summary

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.

Conditions

Leukemia

Keywords

stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Complete Response

  * Normal clinical or X-ray examination (lymph nodes, liver, spleen) * No symptoms * Lymphocytes higher or equal to 4.0 per 10\^9/L * Neutrophils lower or equal to 1.5 per 10\^9/L * Platelets \>100 per 10\^9/L * Hb \>11.0 g/dL * Bone marrow lymphs according to age, lymphocytes \<30%, no nodules.

  At 2 years from study entry

Secondary Outcomes (4)

• Toxicity

  At 2 years from study entry

• Length of Survival

  At 2 years and a half from study entry

• Event-free Survival

  At 2 years from study entry

• Disease-free Survival

  At 2 years from study entry

Study Arms (2)

High risk patientes

EXPERIMENTAL

Category of risk will be defined according to biological features.

Drug: Fludarabine; Drug: Campath; Procedure: Transplant

Low risk patients

EXPERIMENTAL

Category of risk will be defined according to biological features.

Drug: Fludarabine; Drug: Campath

Interventions

Fludarabine DRUG

Induction therapy

High risk patientes

Campath DRUG

Induction therapy

High risk patientes

Transplant PROCEDURE

Post-induction therapy

High risk patientes

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (23)

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

Alessandria, Italy

Location

Universita Degli Studi di Bari

Bari, 70124, Italy

Location

Universita Cattolica del Sacro Cuore - Campobasso

Campobasso, 86100, Italy

Location

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

Catania, 95124, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Ospedale Civile Cosenza

Cosenza, 87100, Italy

Location

Universita di Ferrara

Ferrara, 44100, Italy

Location

Azienda Ospedaliera di Firenze

Florence, 50011, Italy

Location

Ospedale San Martino

Genova, 16132, Italy

Location

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

Lecce, Italy

Location

Azienda Ospedaliera Papardo

Messina, Italy

Location

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

Messina, Italy

Location

Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

Location

Azienda Ospedaliera Bianchi Melacrino Morelli

Reggio Calabria, 89100, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, 00133, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Università Degli Studi "La Sapienza"

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

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

Siena, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10126, Italy

Location

Policlinico Universitario Udine

Udine, 33100, Italy

Location

Related Links

• GIMEMA Foundation Website

MeSH Terms

Conditions

Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

fludarabine; Alemtuzumab; Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Surgical Procedures, Operative

Results Point of Contact

• Title: Alfonso Piciocchi
• Organization: GIMEMA Foundation Data Center

a.piciocchi@gimema.it

+39 06 70390513

Study Officials

• Roberto Foa, MD

  Universita Degli Studi "La Sapeinza"

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 6, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-08

Locations

IT (23)