NCT00002768

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 II trial to study the effectiveness of peripheral stem cell transplantation following chemotherapy in treating patients with acute myeloid leukemia in second remission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

6.7 years

First QC Date

November 1, 1999

Last Update Submit

June 27, 2016

Conditions

Leukemia

Keywords

adult acute myeloid leukemia in remissionadult acute erythroid leukemia (M6)adult acute myeloblastic leukemia without maturation (M1)adult acute myeloblastic leukemia with maturation (M2)adult acute promyelocytic leukemia (M3)adult acute myelomonocytic leukemia (M4)adult acute monoblastic leukemia (M5a)adult acute megakaryoblastic leukemia (M7)adult acute monocytic leukemia (M5b)adult acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    2 years

Study Arms (1)

Autologous stem cell transplantation

EXPERIMENTAL

Patients receive consolidation chemotherapy followed by autologous stem cell transplantation

Biological: filgrastimDrug: busulfanDrug: cytarabineDrug: etoposideDrug: methotrexateProcedure: peripheral blood stem cell transplantation

Interventions

filgrastimBIOLOGICAL

10 microgram/kg body wt subcutaneously daily beginning on d 14 and con't until peripheral blood collection is completed

Also known as: G-CSF
Autologous stem cell transplantation
busulfanDRUG

1 mg/kg PO q 6 hrs for 16 doses on days -7 thru -4.

Autologous stem cell transplantation
cytarabineDRUG

2000 mg/ sq meter IV over 2 hours q 12 hrs x 8 doses on days 1-4

Also known as: Ara-C
Autologous stem cell transplantation
etoposideDRUG

40 mg/kg (total dose) IV cont infusion over 96 hrs on days 1-4 of consolidation therapy and 60 mg/kg IV over 4 hrs on day -3 of transplant

Autologous stem cell transplantation
methotrexateDRUG

For patients with documented CNS disease at first relapse, 12 mg intrathecal for a total of 6 doses given before and/or after transplantation

Autologous stem cell transplantation
peripheral blood stem cell transplantationPROCEDURE

Infusion on Day 0

Autologous stem cell transplantation

Eligibility Criteria

Age15 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of acute myeloid leukemia (AML) in second complete remission (CR) for 30 days to less than 1 year before study entry Second CR defined by the following: Neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Normal bone marrow morphology with no excess blasts (greater than 5%) No myelodysplasia No extramedullary or CNS leukemia Initial diagnosis of de novo AML (M0-M7) No prior myelodysplasia No myeloproliferative disease No secondary AML Cytogenetics not required No cytogenetic evidence of persistent leukemia if cytogenetics performed PATIENT CHARACTERISTICS: Age: 15 to 69 Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal No cirrhosis or chronic hepatitis Biopsy required if chronic liver disease suspected (history of alcohol abuse or possible hepatitis) Renal: Creatinine less than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow/stem cell transplantation Chemotherapy: Prior non-ablative chemotherapy at initial diagnosis, during initial remission, or as reinduction therapy (to produce current second remission) allowed At least 4 weeks since hospital discharge after reinduction therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior post-remission therapy for second remission

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

Sponsors & Collaborators

Study Sites (3)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94115-0128, United States

Location

Marlene & Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Related Publications (1)

  • Linker CA, Owzar K, Powell B, Hurd D, Damon LE, Archer LE, Larson RA; Cancer and Leukemia Group B. Auto-SCT for AML in second remission: CALGB study 9620. Bone Marrow Transplant. 2009 Sep;44(6):353-9. doi: 10.1038/bmt.2009.36. Epub 2009 Mar 16.

    PMID: 19289999RESULT

MeSH Terms

Conditions

LeukemiaLeukemia, Erythroblastic, AcuteLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Monocytic, AcuteLeukemia, Megakaryoblastic, Acute

Interventions

FilgrastimGranulocyte Colony-Stimulating FactorBusulfanCytarabineEtoposideMethotrexatePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles Linker, MD

    University of California, San Francisco

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
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

April 22, 2004

Study Start

June 1, 1996

Primary Completion

February 1, 2003

Study Completion

March 1, 2009

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

US(3)