Decitabine and Clofarabine in Higher Risk Myelodysplastic Syndromes (MDS)

NCT00903760 | Completed Phase 2 Results DMC

• 2 other identifiers: 2008-0092NCI-2011-00263
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control MDS better than decitabine alone. The safety of this drug combination will also be studied.

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; MDS; Leukemia; Decitabine; clofarabine; Dacogen®; Clolar®

Outcome Measures

Primary Outcomes (1)

• Event Free Survival (EFS) at 1 Year

  Percentage of participants with event free survival at 1 year. Event free survival (EFS) where event is defined as either death or transformation to acute myeloid leukemia (AML) (marrow and/or blood blasts \>/= 20%)

  Assessed at 12 months/1 year

Secondary Outcomes (1)

• Participant Response

  Up to 6 months

Study Arms (2)

Decitabine + Clofarabine

EXPERIMENTAL

Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m\^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m\^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.

Drug: Decitabine; Drug: Clofarabine

Decitabine

EXPERIMENTAL

Decitabine 20 mg/m\^2 IV daily for 5 days for a total of 24 courses.

Drug: Decitabine

Interventions

Decitabine DRUG

Decitabine 20 mg/m\^2 by vein daily over 1-2 hours for 5 days for both Group 1 and Group 2. Group 1 receives decitabine on Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21; and Group 2 is on Days 1-5 of every cycle.

Also known as: Dacogen®

Decitabine; Decitabine + Clofarabine

Clofarabine DRUG

Clofarabine 10 mg/m\^2 by vein daily over 1-2 hours for 5 days on Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24.

Also known as: Clolar®

Decitabine + Clofarabine

Eligibility Criteria

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

You may qualify if:

• Patients with higher risk MDS (IPSS int-2 or high, or \>/= 10% blasts as defined by WHO or FAB). - No prior intensive chemotherapy or high-dose cytarabine (\>/= 1 g/m2). - Prior biologic therapies (\</= 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed. - Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease. - Hydroxyurea is permitted for control of counts prior to treatment. - Hematopoietic growth factors are allowed. .
• Age \>/= 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Have adequate renal function (serum creatinine \</= 1.5 mg/dL)
• Serum bilirubin \</= 1.5 x upper limit of normal (ULN)
• Aspartate transaminase (AST) or alanine transaminase (ALT) \</= 2.5 x ULN
• Alkaline phosphatase \</= 2.5 x ULN
• Provide signed written informed consent.
• Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
• Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment.
• Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.

You may not qualify if:

• Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
• Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
• Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
• Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
• Pregnant or lactating patients.
• Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia

Interventions

Decitabine; Clofarabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Arabinonucleosides; Nucleotides; Ribonucleotides

Results Point of Contact

• Title: Guillermo Garcia-Manero, MD / Professor, Leukemia
• Organization: The University of Texas (UT) MD Anderson Cancer Center

ggarciam@mdanderson.org

713-745-3428

Study Officials

• Guillermo Garcia-Manero, M.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 15, 2018
• Results First Posted: November 15, 2018

Record last verified: 2018-10

Locations

US (1)