NCT00050531

Brief Summary

The goal of this clinical research study is to learn if giving PEG-Alpha Interferon (PEG-Intron) and Sargramostim (GM-CSF) to patients receiving treatment with high dose Gleevec (imatinib mesylate) is more effective in treating CML in chronic phase than therapy with imatinib mesylate alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 12, 2002

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2003

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 11, 2016

Status Verified

August 1, 2015

Enrollment Period

4 years

First QC Date

December 12, 2002

Last Update Submit

May 9, 2016

Conditions

Leukemia, Myeloid, Chronic

Keywords

Chronic Myelogenous LeukemiaCMLEarly Chronic Phase Chronic Myelogenous LeukemiaImatinib MesylateGleevecPeg-Alpha InterferonPeg-IntronSargramostimGM-CSF

Outcome Measures

Primary Outcomes (2)

  • Duration of Pathological Complete Response Negativity or Cytogenetic Response

    Duration measured in time from first response to disease progression; Cytogenetic (or FISH), and PCR quantification every 3-4 months as indicated in year one then FISH every 1-3 years and PCR every year

    Molecular response at 12 Months and Polymerase Chain Reaction (PCR) testing once a year (+/- 3 months)

  • Number of Participants with Complete Hematologic Remission (CHR) Classification of Complete Cytogenetic Response

    Complete Hematologic Remission (CHR) - normalization \>4 weeks of bone marrow (less than 5% blasts) \& peripheral blood with white blood count (WBC)\<10x10\^9/L \& no peripheral blasts, promyelocytes or myelocytes, disappearance of all signs \& symptoms of disease. Partial Hematologic Response (PHR) = CHR except persistence of immature cells (myelocytes, metamyelocytes), or splenomegaly \<50% of pretreatment, or thrombocytosis \>450x10\^9/L but \<50% of pretreatment. Complete hematologic remission further classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or fluorescence in situ hybridization (FISH): a) No cytogenetic response - Ph positive 100% of pretreatment value; b) Minor cytogenetic response - Ph positive 35-90% of pretreatment value; c) Partial cytogenetic response - Ph positive 1-34% of pretreatment value; d) Complete cytogenetic response - Ph positive 0%.

    Molecular response at 12 Months

Study Arms (2)

Gleevec

EXPERIMENTAL

Gleevec 400 mg orally twice daily.

Drug: GleevecDrug: Peg-alpha interferon (Peg-Intron)

Gleevec + Peg-Intron + GM-CSF

EXPERIMENTAL

Gleevec 400 mg orally twice daily. Peg-Intron 0.5 mcg/kg each week subcutaneously. GM-CSF 125 mcg/m\^2 three times per week subcutaneously.

Drug: GleevecDrug: Peg-alpha interferon (Peg-Intron)Drug: Sargramostim (GM-CSF)

Interventions

GleevecDRUG

400 mg orally twice daily.

Also known as: Imatinib Mesylate, STI-571
GleevecGleevec + Peg-Intron + GM-CSF
Peg-alpha interferon (Peg-Intron)DRUG

PEG-IFN 0.5 mcg/kg each week subcutaneously.

Also known as: PEG Interferon, Interferon Alfa-2b (PEG conjugate)
GleevecGleevec + Peg-Intron + GM-CSF
Sargramostim (GM-CSF)DRUG

125 mcg/m\^2 three times per week subcutaneously.

Also known as: LeukineTM, Granulocyte-Macrophage Colony Stimulating Factor
Gleevec + Peg-Intron + GM-CSF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Ph-positive CML in early chronic phase CML who have received no or minimal prior therapy, (\<1 month of prior IFN-alpha (with or without ara-C) and/or Gleevec).
  • Eastern Cooperative Oncology Group (ECOG) performance of 0-2.
  • Adequate end organ function, defined as the following: total bilirubin \< 1.5 x upper limit of normal (ULN), serum glutamate pyruvate transaminase (SGPT) \< 2.5 x ULN, creatinine \< 1.5 x ULN
  • Signed informed consent.

You may not qualify if:

  • New York Heart Association (NYHA) cardiac class 3-4 heart disease.
  • Psychiatric disability (psychosis)
  • Pregnant or lactating females
  • Late chronic phase, accelerated or blastic phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • Jain P, Kantarjian H, Boddu PC, Nogueras-Gonzalez GM, Verstovsek S, Garcia-Manero G, Borthakur G, Sasaki K, Kadia TM, Sam P, Ahaneku H, O'Brien S, Estrov Z, Ravandi F, Jabbour E, Cortes JE. Analysis of cardiovascular and arteriothrombotic adverse events in chronic-phase CML patients after frontline TKIs. Blood Adv. 2019 Mar 26;3(6):851-861. doi: 10.1182/bloodadvances.2018025874.

    PMID: 30885996DERIVED

  • Issa GC, Kantarjian HM, Gonzalez GN, Borthakur G, Tang G, Wierda W, Sasaki K, Short NJ, Ravandi F, Kadia T, Patel K, Luthra R, Ferrajoli A, Garcia-Manero G, Rios MB, Dellasala S, Jabbour E, Cortes JE. Clonal chromosomal abnormalities appearing in Philadelphia chromosome-negative metaphases during CML treatment. Blood. 2017 Nov 9;130(19):2084-2091. doi: 10.1182/blood-2017-07-792143. Epub 2017 Aug 23.

    PMID: 28835440DERIVED

  • Jain P, Kantarjian H, Nazha A, O'Brien S, Jabbour E, Romo CG, Pierce S, Cardenas-Turanzas M, Verstovsek S, Borthakur G, Ravandi F, Quintas-Cardama A, Cortes J. Early responses predict better outcomes in patients with newly diagnosed chronic myeloid leukemia: results with four tyrosine kinase inhibitor modalities. Blood. 2013 Jun 13;121(24):4867-74. doi: 10.1182/blood-2013-03-490128. Epub 2013 Apr 25.

    PMID: 23620574DERIVED

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

Imatinib Mesylatepeginterferon alfa-2bInterferon alpha-2sargramostimGranulocyte-Macrophage Colony-Stimulating FactorColony-Stimulating Factors

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth Factors

Study Officials

  • Jorge E Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2002

First Posted

February 7, 2003

Study Start

April 1, 2003

Primary Completion

April 1, 2007

Study Completion

August 1, 2015

Last Updated

May 11, 2016

Record last verified: 2015-08

Locations

US(1)