Fludarabine, Cytarabine, Filgrastim and Idarubicin in Core Binding Factor (CBF) Leukemias
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00801489
First received: December 2, 2008
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to learn if idarubicin 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 idarubicin will increase the long-term chances of patients remaining disease free.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myelogenous Leukemia |
Drug: Fludarabine Drug: Cytarabine Drug: G-CSF (Filgrastim, Neupogen) Drug: Idarubicin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Fludarabine
Idarubicin hydrochloride
Idarubicin
Fludarabine phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Complete Response (CR) Rate and Toxicity Rate [ Time Frame: Weekly blood tests, bone marrow aspirate Days 18-24 and at 4 + 7 months, blood tests every 2-3 months for 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 102 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fludarabine + Cytarabine + Idarubicin + G-CSF
G-CSF = Filgrastim or Neupogen
|
Drug: Fludarabine
30 mg/m^2 intravenously days 1, 2, 3, 4, and 5 (infusion time approximately 30 minutes). Post-Remission Therapy will consist of 3 days rather than 5 days.
Other Name: Fludara®
Drug: Cytarabine
2 g/m^2 intravenously over 4 hours daily days 1, 2, 3, 4, and 5; each infusion begins 3.5 hours after completion of that day's fludarabine infusion - Post-Remission Therapy will consist of 3 days rather than 5 days.
Other Names:
Drug: G-CSF (Filgrastim, Neupogen)
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. (G-CSF 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.
Other Names:
Drug: Idarubicin
6 mg/m2 by vein over 30 minutes to be given immediately after fludarabine administration on Days 3 and 4. Idarubicin will be administered as in induction cycle, in one post-remission cycle (from cycle 3-6). Idarubicin will be given immediately after fludarabine administration on Days 2 and 3.
Other Name: Idamycin
|
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 (the safety of GO in patients <18 years is not determined and advantage of fludarabine, cytarabine, idarubicin-based regimen in CBF leukemias in children is not demonstrated).
- 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, cardiac ejection fraction </= 50%, total bilirubin >/=2 and AST/ALT >/= 3 times 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:
1) Pregnant and lactating females will be excluded since the safety of GO or FLAG + Ida 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:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00801489 History of Changes |
| Other Study ID Numbers: | 2007-0147 |
| Study First Received: | December 2, 2008 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia Acute Myelogenous Leukemia AML |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Fludarabine monophosphate Vidarabine Fludarabine Idarubicin Lenograstim Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 19, 2013