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LeukemiaPhase 3NCT00025402

Chemotherapy and Biological Therapy With or Without Bone Marrow or Peripheral Stem Cell Transplant in Treating Patients With Chronic Myelogenous Leukemia

A Phase 3 study testing filgrastim, recombinant interferon alfa and busulfan in people with Leukemia, run by III. Medizinische Klinik Mannheim at 188 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Any age
Conditions the study is for
Leukemia
What is being tested?
filgrastim, recombinant interferon alfa and busulfan
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
188 sitesin 5 countries
Study dates
Jul 1997to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic myelogenous leukemia in chronic phase
  • Previously untreated
  • Patients negative for Philadelphia chromosome and BCR-ABL translocation must fulfill at least 1 of the following criteria:
  • Impaired health status with reduced exercise tolerance
  • Spleen-related symptoms in cases of splenomegaly
  • Weight loss greater than 10% in 6 months
  • Fever greater than 38.5 degrees C on 5 consecutive days
  • Clinically relevant bone pain
  • Leukocytosis greater than 5,000/mm^3
  • Thrombocytosis greater than 100,000/mm^3

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • No other concurrent malignancy that is likely to require treatment during study or that is likely to reduce life expectancy
  • No severe concurrent disease or other cause that would preclude study
  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior interferon

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Not specified

Trial locations and contacts

188 sites in 5 countries.

188 sites in 5 countries

Germany167 sites

  • Haematologisch Onkologische Praxis

    Aachen, D-52070

  • Kinderklinik - Universitaetsklinikum Aachen

    Aachen, D-52074

  • Urologische Klinik - Universitaetsklinikum Aachen

    Aachen, D-52074

  • Kreiskrankenhaus

    Aalen, 73430

  • Klinikum St. Marien

    Amberg, D-92224

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • II. Medizinische Klinik

    Aschaffenburg, RG 63739

  • Haematologische Praxis

    Augsburg, 86150

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • Kreiskrankenhaus

    Bad Hersfeld, 36251

  • Krankenhaus Hohe Warte Mediziniche Klinik

    Bayreuth, 95445

  • St. Hedwig Kranken Haus

    Berlin, 10115

  • Tumorzentrum Berlin-Moabit

    Berlin, 10967

  • Wenckebach - Krankenhaus

    Berlin, 12099

  • Helios Klinikum Berlin

    Berlin, 13125

  • Haematologisch-Onkologische Schwerpunktpraxis

    Berlin, 13357

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Onkolog - Haematolog Schwerpunktpraxis

    Berlin, D-10559

  • Krankenhaus Neukoelln

    Berlin, D-12313

  • Charite - Campus Virchow Klinikum

    Berlin, D-13353

  • Kinderklinik der Freier Universitaet Berlin

    Berlin, D-14059

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, D-33602

  • Franziskus Hospital

    Bietigheim, 74321

  • Krankenhaus Bietigheim

    Bietigheim, 74321

  • Kreiskrankenhaus Boeblingen

    Böblingen, 71032

  • Europahochhaus

    Bochum, 44787

  • Universitaetsklinikum Bonn

    Bonn, D-53105

  • Medizinische Poliklinik

    Bonn, D-53111

  • Marienhospital Bottrop gGmbH

    Bottrop, D-46236

  • Staedtisches Klinikum Braunschweig

    Braunschweig, D-38114

  • Klinikum Bremen-Mitte

    Bremen, D-28205

  • St. Joseph Hospital

    Bremerhaven, D-27568

  • Zentralkrankenhaus

    Bremerhaven, N 27574

  • Medizinische Klinik Am Lukas - Krankenhaus

    Bünde, 32257

  • Klinikum Coburg

    Coburg, 96450

  • Praxis Gemeinschaft

    Cologne, D-50676

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046

  • Stadt. KH Dresden - Neustadt

    Dresden, 01129

  • Medizinische Klinik I

    Dresden, D-01307

  • Michael Schaefers und Partner

    Duisburg, D-47051

  • St. Johannes Hospital - Medical Klinik II

    Duisburg, D-47166

  • Krankenhaus Dueren

    Düren, 52351

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

  • Hans - Susemihl - Krankenhaus

    Emden, 26721

  • Internistiche Praxis

    Erfurt, 99084

  • Klinikum Erfurt

    Erfurt, 99089

  • Praxis DR. J. Weniger

    Erfurt, D-99085

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052

  • Medizinische Klinik III - Universitaetsklinikum Erlangen

    Erlangen, D-91054

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239

  • Malteser Krankenhaus

    Flensburg, D-24939

  • Onkolog Gemeinschaftspraxis

    Frankfurt, 60389

  • Klinikum der J.W. Goethe Universitaet

    Frankfurt, D-60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, D-79106

  • II Medizinische Klinik - Klinikum Fuerth

    Fürth, D-90766

  • Kreiskrankenhaus Fuessen

    Füssen, 87629

  • Klinikum Garmisch - Partenkirchen GmbH

    Garmisch-Partenkirchen, D-82467

  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

    Giessen, 35392

  • Klinik und Poliklinik fuer Urologie und Kinderurologie

    Giessen, D-35392

  • Klinik fuer Radioonkologie und Strahlentherapie

    Göppingen, 73035

  • DR Herbert - Nieper Krankenhaus Goslar

    Goslar, 38642

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Allgemeines Krankenhaus Hagen

    Hagen, D-58095

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, D-58095

  • Allgemeines Krankenhaus Altona

    Hamburg, 22763

  • Hermann - Holthusen Institute for Radiotherapy

    Hamburg, D-20099

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, D-20246

  • Onkologischer Schwerpunkt Lerchenfeld

    Hamburg, D-22081

  • Asklepios Klinik Barmbek

    Hamburg, D-22291

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22767

  • Evangelische Krankenhaus Hamm

    Hamm, D-59063

  • St. Marien-Hospital Hamm - Klinik Knappenstrasse

    Hamm, D-59071

  • Haematologie Und Internistische Onkologie

    Hanau, 63450

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Medizinische Universitaetsklinik und Poliklinik

    Heidelberg, 69115

  • Klinikum Herford

    Herford, D-32049

  • Universitaetsklinikum des Saarlandes

    Homburg, 66424

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Praxis am Evangelischen Krankenhaus Bethanien

    Iserlohn, D-58644

  • Klinikum der Friedrich-Schiller Universitaet Jena

    Jena, D-07740

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • Gemeinschaftspraxis Brunoehler

    Karlsruhe, 76135

  • St. Vincentius-Kliniken

    Karlsruhe, D-76137

  • Diakonissen - Krankenhaus

    Karlsruhe-Rueppur, 76199

  • Klinikum Kassel

    Kassel, D-34125

  • Klinikum Kempten Oberallgaeu

    Kempten, D-87439

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24105

  • Klinik Konstanz

    Konstanz, 78461

  • Haematologische / Onkologische Schwerpunktpraxis

    Krefeld, 47798

  • Klinikum Krefeld GmbH

    Krefeld, D-47805

  • Vinzentiuskrankenhaus

    Landau, D-76829

  • Caritas - Krakenhaus Lebach

    Lebach, 66822

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • Luisenkrankenhaus

    Lindenfels, 64678

  • Praxis Fuer Haematologie/Onkologie

    Lübeck, D-23560

  • Klinikum der Stadt Ludwigshafen am Rhein

    Ludwigshafen am Rhein, D-67063

  • St Marienkrankenhaus

    Ludwigshafen, Rhein, D-67067

  • Onkologische Schwerpunktpraxis Lueneburg

    Lüneburg, D-21391

  • Gemeinschaftspraxis

    Mannheim, D-68161

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Philipps-Universitaet Marburg Klinikum

    Marburg, D-35033

  • Kreiskrankenhaus Mellrichstadt

    Mellrichstad, DT-97638

  • Klinikum Minden

    Minden, D-32423

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, DOH-41063

  • Universitaets - Kinderpoliklinik

    München, 80336

  • Gemeinschaftspraxis

    Munich, 80331

  • Study site

    Munich, 80637

  • Krankenhaus Muenchen Schwabing

    Munich, 80804

  • Medizinische Kl. Klinikum Innenstadt Universitaet Muenchen

    Munich, D-80336

  • Praxis fuer Innere Medizin und Haematologie

    Munich, D-80797

  • Study site

    Munich, D-81241

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Krankenhaus Muenchen Neuperlach

    Munich, D-81737

  • Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

    Münster, D-48129

  • Ruppiner Klinikum GMBH

    Neuruppin, 16816

  • Gemeinschaftspraxis

    Niddatel-IIbenstadt, 61194

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Gemeinschaftspraxis

    Nuremberg, D-90402

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Klinikum Nuernberg - Klinikum Sued

    Nuremberg, D-90471

  • Hematologische Praxis

    Oldenburg, 26121

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Paracelsus - Klinik Osnabrueck

    Osnabrück, D-49076

  • Staedtisches Krankenhaus

    Pforzheim, 75175

  • Kreiskrankenhaus Radebeul

    Radebeul, D-01445

  • St. Elisabeth Krankenhaus

    Ravensburg, 88212

  • Prosper-Hospital Recklinghausen

    Recklinghausen, D-45659

  • Hematologische Onkologische Praxis

    Regensburg, 93047

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Klinikum der Universitaet Regensburg

    Regensburg, D-93053

  • Klinikum Remscheid GmbH

    Remscheid, D-42859

  • Jakobi Krankenhaus

    Rheine, 48431

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Schwerpunktpraxis fuer Haematologie und Onkologie

    Saarbrücken, D-66113

  • Saechsische Schweiz Klinik

    Sebnitz, D-01855

  • Staedt Krankenhaus

    Sebnitz, D-01855

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Kreiskrankenhaus Siegen

    Siegen, D-57076

  • Klinikum Der Hansestadt Stralsund - Klin. West

    Stralsund, D-18410

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Haematologische Praxis

    Stuttgart, D-70173

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54219

  • Study site

    Trier, D-54290

  • Praxis Fuer Internistische Haematologie / Onkologie

    Troisdorf, 53840

  • Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie

    Tübingen, D-72072

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

  • Bundeswehr Krakenhaus

    Ulm, D-89070

  • Universitaetsklinikum Ulm

    Ulm, D-89081

  • St. Irmgardis Krankenhaus

    Viersen-Suechteln, 41749

  • Klinikum Der Stadt Villingen - Schwenningen

    Villingen-Schwenningen, D-78054

  • Krankenhaus St. Michael

    Voeklingen, 66333

  • Kreiskrankenhaus

    Waldroel, 51545

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, D-65191

  • St. Willehad Hospital

    Wilhelmshaven, D-26382

  • Praxis Fuer Haemotologie Und Internistischer Onkologie

    Wuppertal, 42105

  • Helios Kliniken Wuppertal University Hospital

    Wuppertal, D-42283

  • Kliniken St. Antonius

    Wuppertal, D-42283

Other trials in Germany

Switzerland17 sites

  • Kantonspital Aarau

    Aarau, CH-5001

  • Facharzt FMH Fuer Innere Medizin and Oncology

    Baar, CH-6340

  • Study site

    Basel, CH 4051

  • Universitaetsspital-Basel

    Basel, CH-4031

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

  • Facharzt Fuer Onkologie-Hematologie

    Bern, 3013

  • Inselspital Bern

    Bern, CH-3010

  • Inneremedizin FMH

    Breitenbach, 4226

  • Bezirksspital Dornach

    Dornach, CH-4143

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • FMH f. Innere Medizin and Hematologie

    Gross Höchstetten, 3506

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital, Luzerne

    Luzerne, CH-6016

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

  • Institut Central des Hopitaux Valaisans

    Sion, CH-1951

  • Klinik Hirslanden

    Zurich, CH-8008

  • UniversitaetsSpital Zuerich

    Zurich, CH-8091

Other trials in Switzerland

Poland2 sites

  • Medical University of Gdansk

    Gdansk, 80-211

  • Silesian Medical Academy

    Katowice, 40-029

Other trials in Poland

Czechia1 site

  • Masaryk University Hospital

    Brno, 62500

Other trials in Czechia

Spain1 site

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

Other trials in Spain

About this study

Official title: Randomized Multicenter Treatment Optimization Study In Chronic Myeloid Leukemia (CML) Interferon-a Vs. Allogeneic Stem Cell Transplantation Vs. High-Dose Chemotherapy Followed By Autografting And Interferon-a Maintainance In Early Chronic Phase

RATIONALE: Giving chemotherapy, such as hydroxyurea, cytarabine, idarubicin, and etoposide before a donor bone marrow transplant or stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Interferon alfa may interfere with the growth of cancer cells and slow the growth of cancer. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether chemotherapy is more effective with or without interferon alfa and/or bone marrow or stem cell transplant in treating patients with chronic myelogenous leukemia.

PURPOSE: This randomized phase III trial is studying chemotherapy and biological therapy to see how well it works compared with chemotherapy, biological therapy, and donor bone marrow transplant or autologous stem cell transplant in treating patients with chronic phase chronic myelogenous leukemia.

Read the detailed description

OBJECTIVES:

  • Compare survival in patients with chronic myelogenous leukemia in early chronic phase treated with allogeneic bone marrow transplantation vs drug treatment with or without autologous peripheral blood stem cell transplantation.
  • Compare survival of patients with late-phase disease treated with high-dose cytarabine vs low-dose cytarabine followed by autografting and interferon alfa maintenance.
  • Compare survival of patients not responding cytogenetically to treatment with continued interferon alfa vs hydroxyurea.
  • Determine frequency, time-point, and duration of hematological and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCR-ABL-positive cells on the various treatments.
  • Correlate the quality of hematological and cytogenetic remissions with survival time in patients treated with these regimens.
  • Compare the course of the terminal phase in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Determine the effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time in patients treated with these regimens.
  • Compare the effect of early vs late high-dose therapy plus autografting on feasibility, toxicity, and survival times in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to eligibility for transplantation (yes vs no).

All patients undergo cytoreduction comprising hydroxyurea (HU) IV daily.

Patients who are ineligible for or refuse transplantation are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive interferon alfa (IFN) subcutaneously (SC) daily. After 2 weeks of IFN therapy, patients also receive low-dose cytarabine (ARA-C) SC once daily for 10-15 days each month. Patients who do not achieve cytogenetic remission within 12 months continue to receive HU.
  • Arm II: Patients receive IFN SC daily. After 2 weeks of IFN therapy, patients also receive low-dose ARA-C SC daily for 10-15 days each month. Patients who do not achieve cytogenetic remission within 12 months continue to receive IFN therapy SC daily.

Patients who are eligible for transplantation with a related donor undergo allogeneic bone marrow transplantation. Patients may receive HU or IFN prior to transplantation. Patients may also receive oral high-dose busulfan daily for 4 days with or without cyclophosphamide or cyclophosphamide with total body irradiation.

Patients who are eligible for transplantation but do not have a related donor undergo peripheral blood stem cell (PBSC) harvest and are randomized to 1 of 2 treatment arms.

  • Arm III: Patients receive IFN and low-dose ARA-C as in arm I. Patients who accelerate on treatment may undergo autologous PBSC transplantation.
  • Arm IV: Patients receive idarubicin IV, ARA-C IV over 2 hours, and etoposide IV on days 1-3. Patients then undergo leukapheresis. Beginning on day 8, patients receive filgrastim (G-CSF) SC daily until end of leukapheresis. Patients then receive oral high-dose busulfan daily for 4 consecutive days. The following day, patients undergo reinfusion of autologous PBSC. After blood count recovery, patients receive maintenance IFN 3 times weekly for 8 weeks and then daily.

Patients are followed every 3 months for 3 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within 5 years.

Conditions
Leukemia
Being tested
filgrastim, recombinant interferon alfa, busulfan, cyclophosphamide, cytarabine
Keywords
chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, Philadelphia chromosome negative chronic myelogenous leukemia, childhood chronic myelogenous leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative
Medical subject headings
Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

  2. Frequency, time-point, and duration of hematologic and cytogenetic remissions and of Philadelphia chromosome-negative and/or BCL-ABL-positive cells

  3. Correlation of quality of hematological and cytogenetic remission with survival time

  4. Course of the terminal phase

  5. Toxicity

  6. Effect of prognostic criteria and normal or subnormal WBC on chronic phase duration and survival time

  7. Effect of early vs late high-dose therapy and autografting on feasibility, toxicity and survival times

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00025402
Sponsor's protocol ID
CDR0000068957
Other IDs
III-MK-CML-3A, EU-20118
Status last verified
Jul 2002
First submitted
11 Oct 2001
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, recombinant interferon alfa and busulfan in people with Leukemia, run by III. Medizinische Klinik Mannheim at 188 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 188 sites in Germany, Switzerland, Poland, Czechia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00025402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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