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

NCT00002833 | Completed Phase 2

• 5 other identifiers: DM94-078P30CA016672MDA-DM-94078NCI-G96-1001CDR0000065035
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease; Leukemia; Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 - 36 months

Study Arms (2)

Group 1A

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Filgrastim BIOLOGICAL

Donors receive Filgrastim SC (Subcutaneously) every 12 hours for 2 days prior to stem cell collection.

Also known as: G-CSF, Neupogen

Group 1A; Group 1B

Cladribine DRUG

Continuous infusion for 5 days, beginning 4 hours before Ara-C first dose.

Also known as: Leustatin, 2-CdA

Group 1A

Cyclosporine DRUG

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; Group 1B

Cytarabine (Ara-C) DRUG

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

Group 1A; Group 1B

Fludarabine Phosphate DRUG

IV over 30 minutes daily on days -6, -5, -4 and -3.

Also known as: Fludara, Fludarabine

Group 1B

Idarubicin DRUG

IV Days -6, -5 and -4.

Also known as: Idamycin

Group 1A; Group 1B

Methylprednisolone DRUG

Begins 5 days after infusion and is gradually tapered.

Also known as: Depo-Medrol, Medrol, Solu-Medrol

Group 1A; Group 1B

Peripheral Blood Stem Cell Transplantation PROCEDURE

Cell infusion Day 0.

Also known as: PBSCT, Stem Cell Transplant

Group 1A; Group 1B

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Graft vs Host Disease; Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Cladribine; Cyclosporine; Cytarabine; fludarabine phosphate; fludarabine; Idarubicin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Peripheral Blood Stem Cell Transplantation; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Anemia, Refractory; Anemia; Myelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; 2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Hematopoietic Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Sergio Giralt, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 30, 2004
• Study Start: October 1, 1994
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)