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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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.
Tijdsspanne: 1 year
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1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: 1 year
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1 year
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sherif Farag, MD, PhD, Indiana University
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0704-30 IUCRO-0186
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