Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)

NCT00813124 | Completed Phase 2 Results

• 2 other identifiers: 2008-0087NCI-2012-02122
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stem Cell Transplantation; Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Molecular Response

  Molecular Remission defined as two consecutive bone marrow samples done one month apart with negative PCR( polymerase chain reaction) tor CML.

  12 month post BMT

Study Arms (1)

Azacytidine Maintenance after allotx

EXPERIMENTAL

Busulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx)

Drug: Fludarabine; Drug: Busulfan; Drug: Thymoglobulin; Drug: Azacitidine; Procedure: Stem Cell Transplant

Interventions

Fludarabine DRUG

40 mg/m\^2 by vein over 60 minutes on Day -5 through Day -2.

Also known as: Fludarabine Phosphate

Azacytidine Maintenance after allotx

Busulfan DRUG

Busulfan administered at the dose calculated to achieve an area under curve (AUC) of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).

Also known as: Busulfex, Myleran

Azacytidine Maintenance after allotx

Thymoglobulin DRUG

2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.

Also known as: Antithymocyte globulin, ATG

Azacytidine Maintenance after allotx

Azacitidine DRUG

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.

Also known as: 5-Azacitidine, 5-Aza, 5-AZC, Ladakamycin, NSC-102816, Vidaza

Azacytidine Maintenance after allotx

Stem Cell Transplant PROCEDURE

Stem cell infusion on day 0 administered by vein after collected from donor.

Also known as: allotx, allogeneic stem cell transplantation

Azacytidine Maintenance after allotx

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (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)
• Serum glutamate pyruvate transaminase (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.

You may not qualify if:

• 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 human chorionic gonadotropin (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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Celgene Corporation: 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

Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Graft vs Host Disease

Interventions

fludarabine; fludarabine phosphate; Busulfan; thymoglobulin; Antilymphocyte Serum; Azacitidine; Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Richard E. Champlin, MD/Chair, Stem Cell Transplantation
• Organization: University of Texas (UT) MD Anderson Cancer Center

rchampli@mdanderson.org

713-792-3618

Study Officials

• Richard E. Champlin, MD, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 18, 2008
• First Posted: December 22, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 11, 2021
• Results First Posted: January 7, 2021

Record last verified: 2021-01

Locations

US (1)