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Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002833
  Purpose

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.


Condition Intervention Phase
Graft Versus Host Disease
Leukemia
Myelodysplastic Syndromes
Drug: cladribine
Drug: cyclosporine
Drug: cytarabine
Drug: filgrastim
Drug: fludarabine phosphate
Drug: idarubicin
Drug: methylprednisolone
Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Filgrastim    Cytarabine    Cytarabine hydrochloride    Idarubicin    Idarubicin hydrochloride    Methylprednisolone    Fludarabine    Fludarabine monophosphate    Cyclosporine    Cyclosporin    Granulocyte colony-stimulating factor    Cladribine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   15
Study Start Date:   October 1994

Detailed Description:

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. Methyprednisolone 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.

  Eligibility
Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002833

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Sergio Giralt, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000065035, MDA-DM-94078, NCI-G96-1001
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002833
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia  
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  
blastic phase chronic myelogenous leukemia  
adult acute myeloid leukemia in remission  
Philadelphia chromosome positive chronic myelogenous leukemia
refractory anemia with excess blasts
refractory anemia with excess blasts in transformation
chronic myelomonocytic leukemia
graft versus host disease

Study placed in the following topic categories:
Cladribine
Philadelphia Chromosome
Blast Crisis
Cyclosporine
Precancerous Conditions
Chronic myelogenous leukemia
Clotrimazole
Methylprednisolone
Chronic myelomonocytic leukemia
Refractory anemia
Graft versus host disease
Miconazole
Prednisolone acetate
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid, Acute
Cyclosporins
Leukemia
Preleukemia
Anemia, Refractory
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Cytarabine
Methylprednisolone Hemisuccinate
Myelodysplastic syndromes
Hematologic Diseases
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myelodysplasia
Tioconazole
Anemia

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Antibiotics, Antineoplastic
Hormones
Neuroprotective Agents
Pathologic Processes
Therapeutic Uses
Antifungal Agents
Syndrome
Dermatologic Agents
Disease
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2008




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