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

NCT00002831 | Completed Phase 1

• 5 other identifiers: DM94-064P30CA016672MDA-DM-94064NCI-G96-0999CDR0000065033
• Study Type: interventional
• Target: 24
• 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. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  Study Duration 3 Years

Study Arms (1)

Deoxyazacytidine + Busulfan + Cyclophosphamide

EXPERIMENTAL

Deoxyazacytidine + Busulfan + Cyclophosphamide With Allogeneic Stem Cell Transplantation

Biological: Filgrastim; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Cyclosporine; Drug: Decitabine (DAC); Drug: Methotrexate; Drug: Methylprednisolone; Drug: Tacrolimus; Procedure: Allogeneic Bone Marrow Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation

Interventions

Filgrastim BIOLOGICAL

Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.

Also known as: C-CSF, Neupogen

Deoxyazacytidine + Busulfan + Cyclophosphamide

Busulfan DRUG

Administered orally every 6 hours on consecutive days -6 through -4.

Also known as: Busulfex, Myleran

Deoxyazacytidine + Busulfan + Cyclophosphamide

Cyclophosphamide DRUG

Given intravenously (IV) over 1 hour on consecutive days -3 and -2.

Also known as: Cytoxan, Neosar

Deoxyazacytidine + Busulfan + Cyclophosphamide

Cyclosporine DRUG

Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.

Also known as: Sandimmune, CYA, Cyclosporin A

Deoxyazacytidine + Busulfan + Cyclophosphamide

Decitabine (DAC) DRUG

IV over 4 hours on days -8 and -7.

Also known as: Dacogen

Deoxyazacytidine + Busulfan + Cyclophosphamide

Methotrexate DRUG

Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.

Deoxyazacytidine + Busulfan + Cyclophosphamide

Methylprednisolone DRUG

Given according to clinical grade of GVHD procedures.

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

Deoxyazacytidine + Busulfan + Cyclophosphamide

Tacrolimus DRUG

IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.

Also known as: Prograf

Deoxyazacytidine + Busulfan + Cyclophosphamide

Allogeneic Bone Marrow Transplantation PROCEDURE

Infusion of stem cells on Day 0.

Also known as: ABMT

Deoxyazacytidine + Busulfan + Cyclophosphamide

Peripheral Blood Stem Cell Transplantation PROCEDURE

Stem cell infusion on Day 0.

Also known as: PBSCT

Deoxyazacytidine + Busulfan + Cyclophosphamide

Eligibility Criteria

• Age: 15 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Acute leukemia past first remission or induction failure Chronic myelogenous leukemia in accelerated phase or blast crisis PATIENT CHARACTERISTICS: Age: 15 to 55 Performance status: Zubrod 0-2 Life expectancy: Life expectancy not severely limited by concurrent illness Hematopoietic: Not specified Hepatic: No evidence of chronic active hepatitis or cirrhosis Bilirubin no greater than 2 times upper limit of normal SGPT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 50% No uncontrolled arrhythmias or symptomatic cardiac disease Pulmonary: FEV1, FVC, and DLCO at least 50% No symptomatic pulmonary disease Other: Related donor who is HLA-identical required No effusion or ascites greater than 1 L prior to drainage HIV negative Not pregnant No active CNS disease 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

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Accelerated Phase; Blast Crisis

Interventions

Filgrastim; Busulfan; Cyclophosphamide; Cyclosporine; Decitabine; Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Tacrolimus; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; 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; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Azacitidine; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Macrolides; Lactones; Hematopoietic Stem Cell Transplantation; 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 1
• Allocation: NA
• 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 29, 2004
• Study Start: August 1, 1995
• Primary Completion: December 31, 2002
• Study Completion: December 31, 2002
• Last Updated: October 26, 2018

Record last verified: 2018-10

Locations

US (1)