Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)
This study is currently recruiting participants.
Verified June 2011 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
Collaborator:
Genzyme
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01352650
First received: April 18, 2011
Last updated: June 29, 2011
Last verified: June 2011
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Purpose
The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will improve treatment outcomes via mobilization of leukemia stem cells and alteration of the pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of combining two different doses of plerixafor with a fixed dose and schedule of decitabine.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: plerixafor Drug: decitabine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Induction Therapy With Decitabine and Plerixafor Priming for Patients ≥ 60 Years With Acute Myeloid Leukemia |
Resource links provided by NLM:
Further study details as provided by Weill Medical College of Cornell University:
Primary Outcome Measures:
- response to treatment [ Time Frame: after every cycle (every month) - average subject will be on study for 4-6 months ] [ Designated as safety issue: No ]blood and bone marrow testing will be done to determine response to treatment every month
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Cohort 2B
Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 580 mcg/kg IV on days 1-5 Cycle 2 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 580 mcg/kg IV on days 1-5 Cycle 4 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10
|
Drug: plerixafor
Cohort 1 will receive plerixafor at a dose of 320 mcg/kg and cohort 2 will receive plerixafor at a dose of 580 mcg/kg. Schedule A will receive plerixafor on the 2nd and 4th cycles and Schedule B will receive plerixafor on the 1st and 3rd cycles of treatment.
Other Name: MOZOBIL
Drug: decitabine
decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles
Other Name: Dacogen
|
|
Active Comparator: Cohort 2A
Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 580 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 580 mcg/kg IV on days 1-5
|
Drug: plerixafor
Cohort 1 will receive plerixafor at a dose of 320 mcg/kg and cohort 2 will receive plerixafor at a dose of 580 mcg/kg. Schedule A will receive plerixafor on the 2nd and 4th cycles and Schedule B will receive plerixafor on the 1st and 3rd cycles of treatment.
Other Name: MOZOBIL
Drug: decitabine
decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles
Other Name: Dacogen
|
|
Active Comparator: Cohort 1B
Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10
|
Drug: plerixafor
Cohort 1 will receive plerixafor at a dose of 320 mcg/kg and cohort 2 will receive plerixafor at a dose of 580 mcg/kg. Schedule A will receive plerixafor on the 2nd and 4th cycles and Schedule B will receive plerixafor on the 1st and 3rd cycles of treatment.
Other Name: MOZOBIL
Drug: decitabine
decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles
Other Name: Dacogen
|
|
Active Comparator: Cohort 1A
Cycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5
|
Drug: plerixafor
Cohort 1 will receive plerixafor at a dose of 320 mcg/kg and cohort 2 will receive plerixafor at a dose of 580 mcg/kg. Schedule A will receive plerixafor on the 2nd and 4th cycles and Schedule B will receive plerixafor on the 1st and 3rd cycles of treatment.
Other Name: MOZOBIL
Drug: decitabine
decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles
Other Name: Dacogen
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO criteria) excluding: i) acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA; ii)acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1; iii) acute myeloid leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11.
- AML patients with an antecedent hematologic disorder or myelodysplastic syndrome (MDS)are eligible for treatment on this trial provided that they have not received prior treatment with decitabine or prior cytotoxic treatment for AML.
- AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have not received chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for >6 months.
- Age ≥ 60 years.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Prior treatment with decitabine
- Prior treatment with plerixafor
- Ongoing treatment for another malignancy.
- Patients with good-risk molecular or cytogenetics features
- Patient has a medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational drug treatment.
- Patient has a psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
- Patient has an inability or unwillingness, in the opinion of the investigator, to comply with the protocol requirements.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352650
Contacts
| Contact: Gail Roboz, MD | gar2001@med.cornell.edu |
Locations
| United States, New York | |
| Weill Cornell Medical College | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Gail Roboz, MD gar2001@med.cornell.edu | |
| Principal Investigator: Gail Roboz, MD | |
Sponsors and Collaborators
Weill Medical College of Cornell University
Genzyme
Investigators
| Principal Investigator: | Gail Roboz, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gail Roboz, MD, Weill Cornell Medical College |
| ClinicalTrials.gov Identifier: | NCT01352650 History of Changes |
| Other Study ID Numbers: | 1104011617 |
| Study First Received: | April 18, 2011 |
| Last Updated: | June 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Weill Medical College of Cornell University:
|
leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Decitabine JM 3100 Antimetabolites, Antineoplastic Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013