- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00477542
A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT
A Phase I Trial of Myeloablative Conditioning Using Clofarabine and High-Dose Busulfan for Patients With Refractory Hematological Malignancies Undergoing Allogeneic HSCT
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University Cancer Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Documentation of disease. Patients must have one of the following disease types:
Acute myeloid leukemia (AML) with either:
- Primary refractory to induction chemotherapy
- Relapsed and refractory AML with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
- Patients in second or subsequent complete remission (CR2, CR3, etc.).
Acute lymphoblastic leukemia (ALL) with one of the following criteria:
- Primary refractory to induction chemotherapy.
- Relapsed and refractory ALL with >5% blasts in bone marrow or extramedullary disease (excluding active disease of the central nervous system).
- Patients in second or subsequent complete remission (CR2, CR3, etc.).
- Myelodysplasia, refractory anemia with excess blasts with 11-20% blasts in the bone marrow (RAEB II).
Chronic myelogenous leukemia (CML) with one of the following criteria:
- Accelerated phase.
- Patients in blast crisis.
Patients with aggressive non-Hodgkin's lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria:
- Failure to achieve complete remission to primary induction therapy
- Relapsed NHL, refractory to at least one line of salvage systemic therapy
- Patients who relapse < 6 months following autologous stem cell transplantation are not eligible.
- Patient age 18-60 years
- Availability of a consenting HLA-matched donor
- Performance status ECOG 0-1
- No active infection. Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection.
- No HIV disease. Patients with immune dysfunction are at a significantly higher risk of infection from intensive immunosuppressive therapies.
- Non-pregnant and non-nursing. Treatment under this protocol would expose a fetus to significant risks. Women of childbearing potential should have a negative pregnancy test prior to study entry. Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives (Norplant®), or double barrier method (diaphragm plus condom).
Required baseline laboratory values:
- LVEF > 45% corrected
- DLCO > 50% of predicted value (corrected for hemoglobin)
- Serum creatinine ≤ 2.0 mg/dl or estimated creatinine clearance of ≥60 ml/min
- Bilirubin < 1 x upper limit of normal value
- AST and ALT < 1 x upper limit of normal value
- Signed written informed consent. Patient must be capable of understanding the investigational nature of the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Exclusion Criteria:
- Patients who relapse < 6 months following autologous stem cell transplantation are not eligible
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Determine the MTD of clofarabine in association with a myeloablative dose of busulfan as a preparative regimen in patients with refractory hematological malignancies undergoing allogeneic HSCT.
Lasso di tempo: 1 year
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1 year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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• Assessment of the toxicity of the combination of clofarabine and busulfan • Assess clofarabine and busulfan pharmacokinetics with combination therapy • Describe the response rate • Describe relapse rate and event-free survival
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Sherif Farag, MD, PhD, Indiana University
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0704-30 IUCRO-0186
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .