A Phase 2 interventional study of Filgrastim and Cladribine in Graft Versus Host Disease, Leukemia and Myelodysplastic Syndromes, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-07-30.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
815 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 53 is above the median of 35 across 643 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →M.D. Anderson Cancer Center is the lead sponsor of 3,044 studies on the registry; 578 are open to participants now.
Of its 608 completed or terminated interventional studies of FDA-regulated products, 407 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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.
Biological: Filgrastim · Drug: Cladribine · Drug: Cyclosporine · Drug: Cytarabine (Ara-C) · Drug: Idarubicin · Drug: Methylprednisolone · Procedure: Peripheral Blood Stem Cell Transplantation
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.
Biological: Filgrastim · Drug: Cyclosporine · Drug: Cytarabine (Ara-C) · Drug: Fludarabine Phosphate · Drug: Idarubicin · Drug: Methylprednisolone · Procedure: Peripheral Blood Stem Cell Transplantation
Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.
Also known as: G-CSF, Neupogen
Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.
Also known as: Leustatin, 2-CdA
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.
Also known as: Sandimmune, CYA, Cyclosporin A
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.
Also known as: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
IV over 30 minutes daily on days -6, -5, -4 and -3.
Also known as: Fludara, Fludarabine
IV Days -6, -5 and -4.
Also known as: Idamycin
Begins 5 days after infusion and is gradually tapered.
Also known as: Depo-Medrol, Medrol, Solu-Medrol
Cell infusion Day 0.
Also known as: PBSCT, Stem Cell Transplant
Toxic Effects of Peripheral Stem Cell Transplantation + Filgrastim
Effectiveness as determined by toxic effects and feasibility of using filgrastim in promoting hematopoietic recovery and leukemia control after intensive but nonmyeloablative salvage chemotherapy
Time frame: 24 - 36 months
The record gives a start of Oct 1994, a primary completion of Apr 2002 and a completion of Apr 2002. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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