Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00813124
First received: December 18, 2008
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
| Condition | Intervention | Phase |
|---|---|---|
|
Stem Cell Transplantation Leukemia |
Drug: Fludarabine Drug: Busulfan Drug: Thymoglobulin Drug: Azacitidine Procedure: Stem Cell Transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML) |
Resource links provided by NLM:
Drug Information available for:
Busulfan
Azacitidine
Fludarabine
Fludarabine phosphate
Antilymphocyte Serum
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Complete Molecular Remission Rate [ Time Frame: 1 Month ] [ Designated as safety issue: No ]Molecular Remission defined as 2 negative consecutive quantitative PCR tests done with a sensitivity of at least 1 in 105 cells, done at least one month apart.
| Estimated Enrollment: | 32 |
| Study Start Date: | December 2008 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Azacytidine Maintenance after allotx
Busulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx)
|
Drug: Fludarabine
40 mg/m^2 by vein over 60 minutes on Day -5 through Day -2.
Other Name: Fludarabine Phosphate
Drug: Busulfan
Busulfan administered at the dose calculated to achieve an AUC of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).
Other Names:
Drug: Thymoglobulin
2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.
Other Names:
Drug: Azacitidine
Start cycles of 32 mg/m^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.
Other Names:
Procedure: Stem Cell Transplant
Stem cell infusion on day 0 administered by vein after collected from donor.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with age <= 75 years with CML in first chronic phase, which has failed to achieve a cytogenetic or molecular complete remission or has progressed after imatinib treatment. Criteria for failure are the international consensus criteria (Appendix H). Patients intolerant to tyrosine kinase inhibitor therapy are also eligible.
- Patients with age <= 75 with CML in accelerated phase or blast crisis that have <= 15% blasts in the blood and bone marrow at study entry.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
- Age 18 to 75 years.
- Zubrod performance status <= 2.
- Left ventricular ejection fraction => 40%.
- Pulmonary function test within the following parameters: FEV1, FVC and DLCO => 50% of expected, corrected for hemoglobin.
- Serum creatinine < 1.5 mg/dL or creatinine clearance greater or equal than 40 cc/min.
- Serum direct bilirubin < 1.5 mg/dL (unless Gilbert's syndrome)
- SGPT <= 200 IU/L unless related to patient's malignancy.
- Patients treated with any tyrosine kinase inhibitor, interferon or any experimental therapy are eligible.
- Patients with age <75 years with CML in second or subsequent chronic phase.
Exclusion Criteria:
- Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
- Pleural/pericardial effusion or ascites estimated to be >1L.
- HIV-positive.
- Breast feeding or pregnancy. Pregnancy means a positive beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients with advanced malignant hepatic tumors.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813124
Contacts
| Contact: Richard E. Champlin, MD, BS | 713-792-8750 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Richard E. Champlin, MD, BS | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00813124 History of Changes |
| Other Study ID Numbers: | 2008-0087 |
| Study First Received: | December 18, 2008 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Chronic Myelogenous Leukemia CML Donor stem cell transplant Allogeneic stem cell transplantation Stem cell transplant ATG Antithymocyte globulin Vidaza Azacitidine 5-Azacitidine 5-Aza 5-AZC Ladakamycin NSC-102816 allotx |
Busulfan Busulfex Myleran Fludarabine Fludarabine Phosphate Tacrolimus Methotrexate Azacitidine maintenance therapy molecular remission HLA compatible donor Engraftment Chimerism Graft vs host disease GVHD |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Antilymphocyte Serum Busulfan Fludarabine monophosphate Azacitidine Vidarabine Fludarabine Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents Myeloablative Agonists Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013