Fludarabine, Cytarabine, G-CSF and Gemtuzumab Ozogamicin in CBF Leukemias - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00801489

Purpose

The goal of this clinical research study is to learn if gemtuzumab can be added to the combination of fludarabine, cytarabine, and Neupogen (G-CSF) without increasing the risk of side effects. This study will also look at whether the addition of gemtuzumab will increase the long-term chances of patients remaining disease free.

Condition	Intervention	Phase
Acute Myelogenous Leukemia	Drug: Fludarabine Drug: Cytarabine Drug: Filgrastim (Neupogen, G-CSF) Drug: Gemtuzumab Ozogamicin	Phase II

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

Drug Information available for: Cytarabine hydrochloride Fludarabine Fludarabine monophosphate Filgrastim Granulocyte colony-stimulating factor Gemtuzumab ozogamicin Cytarabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim and Gemtuzumab Ozogamicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Evaluate the safety of a regimen incorporating fludarabine, high-dose Ara-C, filgrastim and gemtuzumab ozogamicin, but excluding anthracyclines, in patients with untreated inv(16) or t(8;21) AML. [ Time Frame: April 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the proportion of patients with untreated inv(16) or t(8;21) AML who, having entered CR on this regimen, remain alive in CR two years from CR date Assess whether the quantitative polymerase chain reaction (Q-PCR) results can be used in detecting [ Time Frame: April 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Fludarabine, cytarabine, Filgrastim & Gemtuzumab Ozogamicin	Drug: Fludarabine fludarabine 30 mg/m2 intravenously days 1, 2, 3, 4, and 5 (infusion time approximately 30 minutes). Post-Remission Therapy will consist of 4 days rather than 5 days. Drug: Cytarabine cytarabine 2 g/m2 intravenously over 4 h daily days 1, 2, 3, 4, and 5; each infusion begins 3.5 h after completion of that day's fludarabine infusion - Post-Remission Therapy will consist of 4 days rather than 5 days. Drug: Filgrastim (Neupogen, G-CSF) filgrastim 5 mcg/kg body weight (rounded off to the nearest number) starting day-1 till recovery of absolute neutrophil count (ANC) to 1.0 x 109/L or above. (filgrastim will be started on day 2 for patients with presenting WBC count > 10 x 109/L. Post-Remission Therapy will consist of 4 days rather than 5 days. Drug: Gemtuzumab Ozogamicin Gemtuzumab ozogamicin 3 mg/m2 intravenously over 2 hours on Day 1. Post-remission therapy Gemtuzumab Ozogamicin will be administered as in induction cycle, in post-remission cycle 2 or 3 and cycle 5 or 6.

Arms

Assigned Interventions

1: Experimental

Fludarabine, cytarabine, Filgrastim & Gemtuzumab Ozogamicin

Drug: Fludarabine

fludarabine 30 mg/m2 intravenously days 1, 2, 3, 4, and 5 (infusion time approximately 30 minutes). Post-Remission Therapy will consist of 4 days rather than 5 days.

Drug: Cytarabine

cytarabine 2 g/m2 intravenously over 4 h daily days 1, 2, 3, 4, and 5; each infusion begins 3.5 h after completion of that day's fludarabine infusion - Post-Remission Therapy will consist of 4 days rather than 5 days.

Drug: Filgrastim (Neupogen, G-CSF)

filgrastim 5 mcg/kg body weight (rounded off to the nearest number) starting day-1 till recovery of absolute neutrophil count (ANC) to 1.0 x 109/L or above. (filgrastim will be started on day 2 for patients with presenting WBC count > 10 x 109/L. Post-Remission Therapy will consist of 4 days rather than 5 days.

Drug: Gemtuzumab Ozogamicin

Gemtuzumab ozogamicin 3 mg/m2 intravenously over 2 hours on Day 1. Post-remission therapy Gemtuzumab Ozogamicin will be administered as in induction cycle, in post-remission cycle 2 or 3 and cycle 5 or 6.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have untreated AML, or high-risk MDS [refractory anemia with excess blasts, (RAEB), or RAEB "in transformation" (RAEB-t)] characterized by t(8;21), inv(16), or t(16;16).The presence of additional abnormalities is irrelevant.
Age equal to or greater than 18 years
Patients must provide written consent.
Because of the high possibility of CR in CBF leukemias, participants will not be excluded based on performance status.For patients with Eastern Co-operative Oncology Group (ECOG) performance status >/= to 3 the dosing schedule will be discussed with study chairman.
Patients with organ dysfunction will not be excluded from the study. For patients with evidence of organ dysfunction (creatinine >/= 1.5, Bilirubin >/=2 and AST/ALT >/= 3 times ULN, dose adjustments will be made.
Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed. If the patient is in remission from induction therapy, he/she will receive post-remission therapy. If the patient is not in remission then he/she will receive induction therapy.
Patients of child bearing potential should practice effective methods of contraception.

Exclusion Criteria:

Patients less than 18 years of age.
Pregnant and lactating females will be excluded since the safety of GO in pregnancy and lactation is unknown.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801489

Contacts

Contact: Gautam Borthakur, MD

713-563-1586

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, MD 713-563-1586
Principal Investigator: Gautam Borthakur, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Gautam Borthakur, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

M.D. Anderson Cancer Center's website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	The University of Texas M.D. Anderson Cancer Center ( Gautam Borthakur M.D./Assistant Professor )
Study ID Numbers:	2007-0147
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801489 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Leukemia
Acute Myelogenous Leukemia
AML

Study placed in the following topic categories:

Antimetabolites
Immunologic Factors
Leukemia, Myeloid
Fludarabine monophosphate
Leukemia, Myeloid, Acute
Gemtuzumab
Immunosuppressive Agents
Antiviral Agents

Antibodies, Monoclonal
Leukemia
Acute Myelocytic Leukemia
Antibodies
Acute Myeloid Leukemia, Adult
Fludarabine
Cytarabine
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid
Fludarabine monophosphate
Leukemia, Myeloid, Acute

Gemtuzumab
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Antibodies, Monoclonal
Leukemia
Neoplasms
Therapeutic Uses
Fludarabine
Cytarabine

ClinicalTrials.gov processed this record on May 07, 2009