Decitabine, Cytarabine, GCSF for Refractory AML/MDS

NCT00740181 | Terminated Phase 2 Results DMC

• 2 other identifiers: BrUOG-AML-217MGI Pharma#DAC 022/2007
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.

Conditions

Myelodysplasia; Leukemia

Keywords

myelodysplasia; refractory leukemia; acute leukemia

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Complete Response/Complete Remission: Complete remission (CR) is defined as the presence of all of the following: * Peripheral blood - No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * No Auer rods * Less than 5% blast cells. * CBC and bone marrow criteria must be met within one week of each other. * Hemoglobin 9g/dl or greater * Neutrophil count \>1000 and platelet count \>100,000. * RBC Transfusion free for 2 weeks.

  within 30 days of last treatment

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5

Drug: chemotherapy

Interventions

chemotherapy DRUG

Chemotherapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must have histological confirmation of disease prior to enrollment on study.
• Patients with de novo AML who are not eligible for induction chemotherapy are eligible. Patients with refractory, relapsed AML are eligible.
• Patients with AML evolving from prior MDS or secondary to prior chemotherapy are eligible provided they are not eligible for standard induction chemotherapy.
• Patients with MDS and with blasts \> 10% (RAEB-II) are eligible.
• Patients with extramedullary relapse only (i.e., leukemia cutis or other extramedullary site) are eligible as long as disease can be monitored.
• Patients who have relapsed after standard autologous and/or allogeneic bone marrow transplant are eligible as long as they meet all other eligibility criteria.
• Patients must not have had any chemotherapy, except hydrea, or radiation for at least 4 weeks prior.
• Patients must be \> 18 years of age.
• Patients with an active second malignancy other than non-melanoma skin cancers are not eligible.
• Patients must have an expected life expectancy of \> 12 weeks at the time of enrollment.
• Patients with visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled. Patients with fungal lung infections must have had treatment for at least one month and have proof of regression prior to enrollment. Patients may be on antimicrobials at the time of therapy.
• Initial required laboratory values:
• Total Bilirubin \< 2 X upper limit of normal.
• AST \& ALT \< 3 X upper limit of normal (if elevated liver enzymes thought likely due to Leukemic infiltrate discuss with the Principal Investigator and the BrUOG Central Office).
• Creatinine \< 2 mg/dl.

Sponsors & Collaborators

• Brown University: lead
• Memorial Hospital of Rhode Island: collaborator
• Roger Williams Medical Center: collaborator

Study Sites (1)

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Anemia, Refractory, with Excess of Blasts; Leukemia

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Anemia, Refractory; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: James Butera
• Organization: Brown Univeristy Oncology Research Group

Kayla_Rosati@brown.edu

401-863-3000

Study Officials

• James Butera

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 21, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 14, 2022
• Results First Posted: July 2, 2013

Record last verified: 2022-01

Locations

US (1)