Decitabine Followed by Partially Matched Related Bone Marrow Transplant for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
This study is currently recruiting participants.
Verified October 2012 by University of Wisconsin, Madison
Sponsor:
University of Wisconsin, Madison
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01707004
First received: October 8, 2012
Last updated: October 12, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to test the results of chemotherapy and radiation given before and after a bone marrow transplant from a partially mismatched related donor.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Procedure: Bone marrow transplant Drug: Decitabine Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Tacrolimus Radiation: 12 Gy Total body radiation |
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: | Decitabine Followed by Partially Matched Related Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia. |
Resource links provided by NLM:
Drug Information available for:
Cyclophosphamide
Decitabine
Mycophenolic acid
Mycophenolate sodium
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
U.S. FDA Resources
Further study details as provided by University of Wisconsin, Madison:
Primary Outcome Measures:
- Overall survival [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]The primary objective is to determine overall survival at 100 days after transplantation following decitabine and a HLA-haploidentical bone marrow transplantation using a myeloablative preparative regimen and post-transplantation cyclophosphamide.
Secondary Outcome Measures:
- Neutrophil recovery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: neutrophil recovery.
- Assessment of graft failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Graft failure.
- Asessment of Acute GVHD and Chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Acute graft-versus-host disease (GVHD)and chronic GVHD.
- Incidence of infection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Incidence of infection.
- Treatment-related mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Treatment-related mortality.
- Platelet recovery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: platelet recovery.
- Time to relapse/progression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Time to relapse/progression.
- Overall patient survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Overall survival.
- Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Patients enrolled in this study will also be followed for the following endpoints: Progression-free survival.
| Estimated Enrollment: | 20 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Decitabine, bone marrow transplant
Patients will receive decitabine 20 mg/m2 IV for 10 consecutive days. Beginning 7 - 14 days later, patients will receive 12 Gy total body radiation followed by bone marrow transplant. GVHD prophylaxis will consist of high dose cyclophosphamide, mycophenolate mofetil, and tacrolimus.
|
Procedure: Bone marrow transplant Drug: Decitabine Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Tacrolimus Radiation: 12 Gy Total body radiation |
Detailed Description:
This study is a Phase II study of decitabine followed by myeloablative conditioning, transplantation of partially HLA-mismatched bone marrow and post-transplantation cyclophosphamide in patients with acute myelogenous leukemia, and high-risk myelodysplastic syndrome.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Acute myelogenous leukemia
- Myelodysplastic syndromes
- Available related donor that is at least a high resolution (allele level) haplotype match at HLA A, B, C, DRB1 and DQB1.
Exclusion Criteria:
- Active CNS leukemia within two weeks of registration
- New or active infection
- Active HIV, hepatitis A, B or C infection
- Allergy or hypersensitivity to agents used within the treatment protocol.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707004
Contacts
| Contact: Mark B Juckett, M.D. | 608-263-0338 | mbj@medicine.wisc.edu |
Locations
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | Recruiting |
| Madison, Wisconsin, United States, 53719 | |
| Contact: Mark B Juckett, M.D. 608-263-0338 mbj@medicine.wisc.edu | |
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
| Principal Investigator: | Mark B Juckett, M.D. | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT01707004 History of Changes |
| Other Study ID Numbers: | HO11421 |
| Study First Received: | October 8, 2012 |
| Last Updated: | October 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
|
Relapsed Refractory |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cyclophosphamide Mycophenolate mofetil Tacrolimus Decitabine Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Enzyme Inhibitors Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 23, 2013