Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia
Use of G-CSF Stimulated HLA-Identical Allogeneic Peripheral Blood Stem Cells for Patients With High Risk Acute Myelogenous Leukemia or CML in Blast Crisis
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
Studieoversikt
Status
Detaljert beskrivelse
OBJECTIVES: I. Determine the toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy. II. Determine the engraftment kinetics and degree of chimerism achievable.
OUTLINE: The trial will have 2 patient groups. Patients not in remission are assigned to group 1, while patients in remission are assigned to group 2. Then, groups are divided into 2 treatment arms. Patients failing fludarabine therapy receive cytarabine (Ara-C) IV over 2 hours on days -7, -6, -5, -4 and -3. Beginning 4 hours before the first dose of Ara-C, patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) by continuous infusion for 5 days. Patients without prior fludarabine therapy receive fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after the beginning of the fludarabine infusion and continues for 4 hours. Idarubicin IV is given on days -6, -5 and -4. Donors receive filgrastim SC every 12 hours for 2 days prior to stem cell collection. Cells are infused on day 0. For GVHD prophylaxis, all patients receive cyclosporine via continuous IV infusion. Oral cyclosporine is administered once patients tolerate oral feeding and continued for 6 months postinfusion. Then, the dose of cyclosporine is tapered 10% weekly until discontinued. Methylprednisolone begins 5 days after infusion and is gradually tapered.
PROJECTED ACCRUAL: A maximum of 15 patients per arm are likely to be entered in 24 to 36 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Texas
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Houston, Texas, Forente stater, 77030
- University of Texas - MD Anderson Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS: Acute leukemia with poor risk cytogenetic features (-5,-7, +8) in first complete remission Poor risk myelodysplasia Refractory anemia with excess blasts (RAEB) RAEB in transformation (RAEB-T) Chronic myelomonocytic leukemia (CMML) Chronic myelogenous leukemia (CML) in late chronic phase Acute leukemia with greater than first complete remission or transformed CML or CMML
PATIENT CHARACTERISTICS: Age: 55 to 65 65 to 70 (at the discretion of study chairperson on basis of performance status) 55 and under (if declined for conventional high dose chemotherapy due to concurrent medical conditions (i.e. ejection fraction less than 50, FEV1, FVC, or DLCO less than 50%, abnormal LFTs) Performance status: Zubrod less than 2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Serum creatinine less than 2 mg/dL Cardiovascular: Ejection fraction greater than 40% per MUGA scan Pulmonary: Not specified Other: No active uncontrolled infection HLA compatible donor capable of donating stem cells via apheresis
PRIOR CONCURRENT THERAPY: Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Group 1A
Group 1A - With or Without Remission + Failing Fludarabine therapy: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3 with Cladribine continuous infusion for 5 days, beginning 4 hours before Ara-C first dose. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered. |
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Andre navn:
Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
Andre navn:
For GVHD prophylaxis, cyclosporine via continuous IV infusion.
Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion.
Then dose tapered 10% weekly until discontinued.
Andre navn:
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Andre navn:
IV Days -6, -5 and -4.
Andre navn:
Begins 5 days after infusion and is gradually tapered.
Andre navn:
Cell infusion Day 0.
Andre navn:
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|
Eksperimentell: Group 1B
Group 1B: With or Without Remission, No previous Fludara Therapy Fludarabine IV over 30 minutes daily on days -6, -5, -4 and -3. Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours. Idarubicin IV Days -6, -5 and -4. Cells infused on day 0. Cyclosporine via continuous IV infusion, oral cyclosporine administered for 6 months postinfusion (tapered 10% weekly until discontinued). Methylprednisolone begins 5 days after infusion then gradually tapered. |
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Andre navn:
For GVHD prophylaxis, cyclosporine via continuous IV infusion.
Oral cyclosporine administered once tolerating oral feeding and continued for 6 months postinfusion.
Then dose tapered 10% weekly until discontinued.
Andre navn:
Group 1A: Ara-C IV over 2 hours on days -7, -6, -5, -4 and -3; Group 1B: Ara-C IV begins 4 hours after fludarabine infusion, continues for 4 hours.
Andre navn:
IV Days -6, -5 and -4.
Andre navn:
Begins 5 days after infusion and is gradually tapered.
Andre navn:
Cell infusion Day 0.
Andre navn:
IV over 30 minutes daily on days -6, -5, -4 and -3.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Toxic Effects of Peripheral Stem Cell Transplantation + Filgrastim
Tidsramme: 24 - 36 months
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Effectiveness as determined by toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy
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24 - 36 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Sergio Giralt, MD, M.D. Anderson Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- refraktær anemi med overflødig blaster
- refraktær anemi med overskytende blaster i transformasjon
- kronisk myelomonocytisk leukemi
- kronisk fase kronisk myelogen leukemi
- tilbakevendende akutt myeloid leukemi hos voksne
- akutt myeloid leukemi hos voksne i remisjon
- blastisk fase kronisk myelogen leukemi
- tilbakefallende kronisk myelogen leukemi
- Philadelphia kromosom positiv kronisk myelogen leukemi
- akselerert fase kronisk myelogen leukemi
- graft versus host sykdom
Ytterligere relevante MeSH-vilkår
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Benmargssykdommer
- Hematologiske sykdommer
- Myeloproliferative lidelser
- Myelodysplastiske syndromer
- Leukemi
- Leukemi, myeloid
- Leukemi, myelogen, kronisk, BCR-ABL positiv
- Graft vs vertssykdom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Antivirale midler
- Enzymhemmere
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Nevrobeskyttende midler
- Beskyttende agenter
- Topoisomerase II-hemmere
- Topoisomerasehemmere
- Dermatologiske midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Calcineurin-hemmere
- Prednisolon
- Metylprednisolonacetat
- Metylprednisolon
- Metylprednisolon Hemisuccinat
- Prednisolonacetat
- Prednisolon hemisuccinat
- Prednisolonfosfat
- Fludarabin
- Fludarabinfosfat
- Cytarabin
- Idarubicin
- Kladribin
- Syklosporin
- Syklosporiner
Andre studie-ID-numre
- DM94-078
- P30CA016672 (U.S. NIH-stipend/kontrakt)
- MDA-DM-94078 (Annen identifikator: UT MD Anderson Cancer Center)
- NCI-G96-1001
- CDR0000065035 (Registeridentifikator: NCI PDQ)
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