Trial Title:
Fludarabine Phosphate, Cytarabine, Filgrastim-sndz, Gemtuzumab Ozogamicin, and Idarubicin Hydrochloride in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
NCT ID:
NCT00801489
Condition:
Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1
de Novo Myelodysplastic Syndrome
High Risk Myelodysplastic Syndrome
Inv(16)
Myelodysplastic Syndrome With Excess Blasts
t(16;16)
t(8;21)
Untreated Adult Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Anemia, Refractory, with Excess of Blasts
Syndrome
Cytarabine
Fludarabine
Fludarabine phosphate
Decitabine
Idarubicin
Gemtuzumab
Calicheamicins
Lenograstim
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cytarabine
Description:
Given IV
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
.beta.-Cytosine arabinoside
Other name:
1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone
Other name:
1-.beta.-D-Arabinofuranosylcytosine
Other name:
1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone
Other name:
1-Beta-D-arabinofuranosylcytosine
Other name:
1.beta.-D-Arabinofuranosylcytosine
Other name:
2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-
Other name:
2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-
Other name:
Alexan
Other name:
Ara-C
Other name:
ARA-cell
Other name:
Arabine
Other name:
Arabinofuranosylcytosine
Other name:
Arabinosylcytosine
Other name:
Aracytidine
Other name:
Aracytin
Other name:
Aracytine
Other name:
Beta-cytosine Arabinoside
Other name:
CHX-3311
Other name:
Cytarabinum
Other name:
Cytarbel
Other name:
Cytosar
Other name:
Cytosine Arabinoside
Other name:
Cytosine-.beta.-arabinoside
Other name:
Cytosine-beta-arabinoside
Other name:
Erpalfa
Other name:
Starasid
Other name:
Tarabine PFS
Other name:
U 19920
Other name:
U-19920
Other name:
Udicil
Other name:
WR-28453
Intervention type:
Drug
Intervention name:
Decitabine
Description:
Given IV
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
5-Aza-2'-deoxycytidine
Other name:
Aza-TdC
Other name:
Dacogen
Other name:
Decitabine for Injection
Other name:
Deoxyazacytidine
Other name:
Dezocitidine
Intervention type:
Biological
Intervention name:
Filgrastim-sndz
Description:
Given SC
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
Filgrastim Biosimilar Filgrastim-sndz
Other name:
Zarxio
Intervention type:
Drug
Intervention name:
Fludarabine Phosphate
Description:
Given IV
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
2-F-ara-AMP
Other name:
9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-
Other name:
Beneflur
Other name:
Fludara
Other name:
SH T 586
Intervention type:
Drug
Intervention name:
Gemtuzumab Ozogamicin
Description:
Given IV
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
Calicheamicin-Conjugated Humanized Anti-CD33 Monoclonal Antibody
Other name:
CDP-771
Other name:
CMA-676
Other name:
gemtuzumab
Other name:
hP67.6-Calicheamicin
Other name:
Mylotarg
Other name:
WAY-CMA-676
Intervention type:
Drug
Intervention name:
Idarubicin
Description:
Given IV
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Other name:
4-Demethoxydaunomycin
Other name:
4-demethoxydaunorubicin
Other name:
4-DMDR
Intervention type:
Other
Intervention name:
Laboratory Biomarker Analysis
Description:
Correlative studies
Arm group label:
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
Summary:
This phase II trial studies the side effects and how well fludarabine phosphate,
cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in
treating patients with newly diagnosed acute myeloid leukemia or high-risk
myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate,
cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of
cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab
ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug,
called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to
specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors,
and delivers calicheamicin to kill them. Colony-stimulating factors, such as
filgrastim-sndz, may increase the number of immune cells found in bone marrow or
peripheral blood and may help the immune system recover from the side effects of
chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab
ozogamicin, and idarubicin hydrochloride may kill more cancer cells.
Detailed description:
PRIMARY OBJECTIVES:
I. Evaluate the safety of a regimen incorporating fludarabine phosphate (fludarabine),
high-dose cytarabine, filgrastim-sndz, gemtuzumab ozogamicin and idarubicin hydrochloride
(idarubicin) in patients with untreated inv(16) or t(8;21) acute myeloid leukemia (AML).
II. Evaluate the complete remission rates achieved in this population with this regimen.
SECONDARY OBJECTIVES:
I. Assess the proportion of patients with untreated inv(16) or t(8;21) AML who, having
entered complete remission (CR) on this regimen, remain alive in CR two years from CR
date.
II. Assess whether the quantitative polymerase chain reaction (Q-PCR) results can be used
in detecting relapse in these patients.
OUTLINE:
REMISSION INDUCTION: Patients receive filgrastim-sndz subcutaneously (SC) once daily (QD)
beginning on day -1 and continuing until blood count recovery. Patients also receive
fludarabine phosphate intravenously (IV) over 30 minutes on days 1-5, cytarabine IV over
4 hours on days 1-5, gemtuzumab ozogamicin IV over 2 hours on day 1. Patients not in
remission after their first induction therapy may repeat remission induction therapy.
POST-REMISSION THERAPY: Patients receive filgrastim-sndz SC on day -1, fludarabine
phosphate IV over 30 minutes on days 1-3, cytarabine IV over 4 hours on days 1-3,
gemtuzumab ozogamicin IV over 2 hours on day 1 of courses 1 or 2 and 5 or 6, and
idarubicin hydrochloride IV over 30 minutes on days 2 and 3 of one post-remission course
(post-remission courses 3 or 4) determined by the treating physician after discussion
with the PI if suboptimal qPCR response (qPCR > 0.01 after post-remission cycle 2 or 3).
Treatment repeats every 4-6 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
FURTHER MODIFICATION OF POST-REMISSION THERAPY: Patients older than 60, with significant
comorbidities, experiencing life-threatening complications, prolonged cytopenias, or not
achieving complete molecular response may receive decitabine IV over 1 hour daily for 5
days after discussion with the principal investigator. Treatment repeats every 4-6 weeks
for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for 2 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have untreated AML, or high-risk myelodysplastic syndromes (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
- Patients must provide written consent
- Participants will not be excluded based on performance status; for patients with
Eastern Cooperative 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, cardiac ejection fraction =<
50%, total bilirubin >=2 and aspartate aminotransferase [AST]/alanine
aminotransferase [ALT] >= 3 times upper limit of normal [ULN]), dose
adjustments/omissions 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:
- Pregnant and lactating females will be excluded
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gautam Borthakur
Phone:
713-563-1586
Investigator:
Last name:
Gautam Borthakur
Email:
Principal Investigator
Start date:
April 4, 2007
Completion date:
December 30, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00801489
http://www.mdanderson.org
