Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Patients With Acute Promyelocytic Leukemia
Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Apr 10, 2003
Trial Information
Current as of March 16, 2025
Unknown status
Keywords
ClinConnect Summary
OBJECTIVES:
* Determine the complete remission (CR) rate in patients with acute promyelocytic leukemia treated with induction comprising tretinoin (ATRA) and idarubicin (IDA).
* Determine the presence of the promyelocyte-retinoic acid receptor alpha (PML-RARa) transcript using polymerase chain reaction (PCR) in patients with CR after 3 sequential consolidation regimens comprising cytarabine (ARA-C) plus IDA, followed by mitoxantrone plus etoposide, and then IDA, ARA-C, and thioguanine.
* Determine the percentage of patients who complete the protocol, including PML-RARa-positive patients tr...
Gender
ALL
Eligibility criteria
- DISEASE CHARACTERISTICS:
- • Newly diagnosed acute promyelocytic leukemia
- • Must have promyelocyte-retinoic acid receptor alpha transcript at disease presentation
- PATIENT CHARACTERISTICS:
- Age:
- • 16 to 74
- Performance status:
- • Not specified
- Life expectancy:
- • Not specified
- Hematopoietic:
- • Not specified
- Hepatic:
- • Bilirubin no greater than 3 times upper limit of normal (ULN)
- • AST no greater than 3 times ULN
- • Alkaline phosphatase no greater than 3 times ULN
- Renal:
- • Creatinine no greater than 2.5 mg/dL
- Cardiovascular:
- • No cardiac contraindication to anthracycline chemotherapy
- Other:
- • No active serious infection not controlled by antibiotics
- • No severe concurrent psychiatric disease
- • No other malignancy except basal cell carcinoma
- • Not pregnant or nursing
- • Negative pregnancy test
- PRIOR CONCURRENT THERAPY:
- Biologic therapy:
- • Not specified
- Chemotherapy:
- • No concurrent cytotoxic chemotherapy
- Endocrine therapy:
- • Prior corticosteroids for leukemia allowed
- Radiotherapy:
- • No concurrent radiotherapy
- Surgery:
- • Not specified
- Other:
- • No prior antileukemic therapy
Trial Officials
Petra Muus, MD, PhD
Study Chair
Universitair Medisch Centrum St. Radboud - Nijmegen
Franco Mandelli, MD
Study Chair
Azienda Policlinico Umberto Primo
About European Organisation For Research And Treatment Of Cancer Eortc
The European Organisation for Research and Treatment of Cancer (EORTC) is a prominent non-profit organization dedicated to advancing cancer research and improving patient care through innovative clinical trials. Established in 1962, EORTC fosters collaboration among international researchers, healthcare professionals, and institutions to develop and implement rigorous clinical studies that evaluate novel therapies and treatment strategies. With a strong commitment to enhancing the quality of life for cancer patients, EORTC focuses on multidisciplinary approaches and the integration of patient-reported outcomes, ensuring that its findings translate effectively into clinical practice and contribute to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, , Belgium
Milano, , Italy
Pavia, , Italy
Nijmegen, , Netherlands
Rotterdam, , Netherlands
Antwerp, , Belgium
Brugge, , Belgium
Brussels (Bruxelles), , Belgium
Brussels (Bruxelles), , Belgium
Brussels, , Belgium
Lyon, , France
Nice, , France
Paris, , France
Paris, , France
Suresnes, , France
Villejuif, , France
'S Gravenhage (Den Haag, The Hague), , Netherlands
'S Hertogenbosch, , Netherlands
Leiden, , Netherlands
Edegem, , Belgium
Amsterdam, , Netherlands
Groningen, , Netherlands
Lille, , France
Rome, , Italy
Liege, , Belgium
Zagreb (Agram), , Croatia
Zagreb, , Croatia
Munich (Muenchen), , Germany
Alessandria, , Italy
Ancona, , Italy
Avellino, , Italy
Bari, , Italy
Brindisi, , Italy
Cagliari, , Italy
Catania, , Italy
Catanzaro, , Italy
Cremona, , Italy
Cuneo, , Italy
Foggia, , Italy
Gallarate Varese, , Italy
Latina, , Italy
Lodi, , Italy
Milano (Milan), , Italy
Naples (Napoli), , Italy
Naples (Napoli), , Italy
Naples (Napoli), , Italy
Naples (Napoli), , Italy
Nuoro, , Italy
Palermo, , Italy
Palermo, , Italy
Parma, , Italy
Perugia, , Italy
Pesaro, , Italy
Pescara, , Italy
Potenza, , Italy
Rome, , Italy
Rome, , Italy
San Giovanni Rotondo, , Italy
Sassari, , Italy
Taranto, , Italy
Turin (Torino), , Italy
Verviers, , Belgium
Firenze (Florence), , Italy
Montefiascone, , Italy
Innsbruck, , Austria
Prague, , Czech Republic
Duisburg, , Germany
Genoa (Genova), , Italy
Padova (Padua), , Italy
Turin (To), , Italy
Ankara, , Turkey
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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