Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

NCT01019317 | Completed Phase 2 Results

• 1 other identifier: 2009-0781
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.

Conditions

Leukemia; AML; MDS; CML

Keywords

Acute Myelogenous Leukemia; High-Risk Myelodysplastic Syndrome; Chronic myeloid leukemia; CML; Blast crisis; Cytarabine; Ara-C; Cytosar; DepoCyt; Cytosine arabinosine hydrochloride; Arabinosine Hydrochloride; Fludarabine; Fludarabine Phosphate; Fludara; Gemtuzumab Ozogamicin; Mylotarg

Outcome Measures

Primary Outcomes (1)

• Participants With a Complete Response

  Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.

  Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles)

Study Arms (1)

Cytarabine + Fludarabine

EXPERIMENTAL

Fludarabine 15 mg/m\^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m\^2 IV over 2 hours every 12 hours for 5 days.

Drug: Cytarabine; Drug: Fludarabine

Interventions

Cytarabine DRUG

0.5 grams/m\^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients \> 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3).

Also known as: Ara-C, Cytosar, DepCyt, Cytosine arabinosine hydrochloride

Cytarabine + Fludarabine

Fludarabine DRUG

15 mg/m\^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients \> 65 years and 3 days in patients with PS \> 3).

Also known as: Fludara, Fludarabine Phosphate

Cytarabine + Fludarabine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign an Internal Review Board (IRB)-approved informed consent document.
• Age \>/= 12 years.
• Diagnosis of AML \[other than acute promyelocytic leukemia (APL)\] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or \>/=10% blasts) MDS will also be eligible. Patients with chronic myeloid leukemia (CML) in blast crisis will be eligible as well.
• Eastern Cooperative Oncology Group (ECOG) performance status of \</= 3 at study entry.
• Organ function as defined below (unless due to leukemia):
• i. Serum creatinine \</= 3 mg/dL; ii. Total bilirubin \</= 3 mg/dL; iii. Alanine aminotransferase (ALT)(Serum Glutamic Pyruvate Transaminase (SGPT)) \</= 5 times upper limit of normal (ULN) or \</= 10 times ULN if related to disease.
• Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days . Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

You may not qualify if:

• Pregnant or breastfeeding females.
• Diagnosis of acute promyelocytic leukemia (M3).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis

Interventions

Cytarabine; fludarabine; fludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Elias Joseph Jabbour MD/Assistant Professor
• Organization: University of Texas (UT) MD Anderson Cancer Center

eharriso@mdanderson.org

713-792-4764

Study Officials

• Elias Jabbour, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 15, 2016
• Results First Posted: December 3, 2013

Record last verified: 2013-10

Locations

US (1)