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Study Summary
No. 2007-0147:.......Leukemia......Gautam Borthakur......Leukemia
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Study Summary Title
Study Summary
Number:		2007-0147
Study Title:A Phase 2 Study of Fludarabine, cytarabine, Filgrastim and Gemtuzumab Ozogamicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
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Physician New Patient Referral
Name:Gautam BorthakurPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1586
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Once a month for approximately 7 months
Treatment
Agents:		ARA-C
Fludarabine
G-CSF
Gemtuzamab Ozogamicin		Home Care:Supportive care that includes blood transfusions, antibiotics or growth factors
including G-CSF as per protocol can be administered by local oncologist.
Patients can be instructed to self-administer G-CSF.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients will be admitted for the duration of induction chemotherapy. Patients
over the age of 50 years will be given the option of staying in the "protected
environment" for the approximately 4 weeks of induction to remission.
Description/
Intervention:		The goal of this clinical research study is to learn if gemtuzumab can be added
to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim)
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.
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Study Objectives / Outcomes
      Primary:
      Evaluate the safety of a regimen incorporating fludarabine, high-dose cytarabine, filgrastim and gemtuzamab ozogamicin, but excluding anthracyclines, in patients with untreated inv(16) or t(8;21) AML.

      Evaluate the complete remission rates achieved in this population with this regimen
      Secondary:
      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 relapse in these patients.
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Study Status Information
Study Activation / Registration Date:04/04/2007
IRB Review and Approval Date:04/04/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) 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.

2) Age equal to or greater than 18 years

3) Patients must provide written consent.

4) 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.

5) Patients with organ dysfunction will not be excluded from the study. For patients with evidence of organ dysfunction (creatininie >/= 1.5, Bilirubin >/=2 and AST/ALT >/= 3 times ULN, dose adjustments will be made.

6) 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.

7) Patients of child bearing potential should practice effective methods of contraception.
Exclusion Criteria:1) Pregnant and lactating females will be excluded since the safety of GO in pregnancy and lactation is unknown.
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Links
Registration Number: NCT00801489
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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