LeukemiaPhase 2NCT00055653
Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
A Phase 2 study testing anti-thymocyte globulin, filgrastim and busulfan in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 25 sites in United States.
Trial summary
RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- What is being tested?
- anti-thymocyte globulin, filgrastim and busulfan
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 25 sitesUnited States
- Study dates
- Jan 2003to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia (AML)*
- With or without history of myelodysplastic syndromes (MDS)
- Patients in first complete remission (CR) (no greater than 5% blasts in marrow) with translocations t(8;21) and inv(16) are allowed provided they failed first-line induction therapy
- Patients in first CR (no greater than 5% blasts in marrow) with translocations t(15;17) are allowed provided at least 1 of the following is true:
- Failed first-line induction therapy
- Molecular evidence of persistent disease
- No patients in first CR and with Down syndrome
- Acute lymphoblastic leukemia (ALL)*, meeting 1 of the following criteria:
- Not in first CR (no greater than 5% blasts in marrow)
- In first CR and high risk as defined by 1 of the following:
- Hypoploidy (no more than 44 chromosomes)
- Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14) (excluding B-ALL) or +MLL gene rearrangement
- One of the following elevated WBC levels:
- WBC greater than 100,000/mm^3 if 6 to 12 months of age
- WBC greater than 200,000/mm^3 if between 10 and 17 years of age
- WBC greater than 20,000/mm^3 if 18 years of age and over (adult [over 18 years of age] patient stratum closed to accrual)
- Failed to achieve CR after 4 weeks of induction therapy
- B-ALL that is not in first CR or that meets at least 1 of the high-risk criteria specified above
- No translocation t(8;14)
- No blasts with surface immunoglobulins
- CD10 negative
- Undifferentiated leukemia*
- Infant leukemia*
- Biphenotypic leukemia*
- Chronic myelogenous leukemia, meeting 1 of the following criteria:
- Accelerated phase
- Chronic phase
- At least 1 year from diagnosis without an identified matched unrelated bone marrow donor AND unresponsive to or unable to tolerate interferon
- Blast crisis* (greater than 30% promyelocytes plus blasts in the marrow)
- One of the following MDS:
- Refractory anemia
- Refractory anemia with ringed sideroblasts
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Paroxysmal nocturnal hemoglobinuria
- Hodgkin's or non-Hodgkin's lymphoma beyond first CR or failed primary induction therapy
- Tumor displays chemosensitivity (greater than 50% reduction in mass size after the most recent therapy) NOTE: *Patients in third or greater medullary relapse or refractory disease (other than primary induction failures) or blast crisis receive the study busulfan/melphalan conditioning regimen)
OR
- Diagnosis of one of the following nonmalignant diseases :
- Acquired severe aplastic anemia (stratum closed to accrual)
- Unresponsive to medical therapy with anti-thymocyte globulin and/or cyclosporine
- Inborn errors of metabolism, including, but not limited to the following:
- Hurler's syndrome
- Adrenoleukodystrophy
- Maroteaux-Lamy syndrome
- Globoid cell leukodystrophy
- Metachromatic leukodystrophy
- Fucosidosis
- Mannosidosis
- Fanconi anemia documented by increased chromosomal fragility assays and meeting 1 of the following criteria (stratum closed to accrual):
- Severe pancytopenia
- Absolute neutrophil count less than 500/mm^3
- Platelet count less than 20,000/mm^3
- Hemoglobin less than 8 g/dL
- Morphologic evidence of MDS with clonal chromosomal abnormalities
- Leukemia transformation
- Other marrow failure syndromes, including any of the following (stratum closed to accrual):
- Blackfan-Diamond syndrome that is unresponsive to medical therapy
- Kostmann's congenital agranulocytosis unresponsive to medical therapy
- Congenital amegakaryocytic thrombocytopenia
- Thrombocytopenia absent radius
- Combined immune deficiencies including, but not limited to the following:
- Severe combined immunodeficiency (SCID)
- Wiskott-Aldrich syndrome
- Leukocyte adhesion defect
- Chediak-Higashi disease
- X-linked lymphoproliferative disease
- Adenosine deaminase deficiency
- Purine nucleoside phosphorylase deficiency
- X-linked SCID
- Common variable immune deficiency
- Nezeloff's syndrome
- Cartilage hair hypoplasia
- Reticular dysgenesis
- No active CNS leukemia (cerebrospinal fluid with WBC greater than 5/mm^3 and malignant cells on cytospin)
- No SCID patients who do not require cytoreduction
- No dyskeratosis congenita
- No primary myelofibrosis
- No grade 3 or greater myelofibrosis
- Familial erythrophagocytic lymphohistiocytosis patients must not have any of the following:
- Abnormal brain MRI
- Neurologic symptoms
- Lymphocytes and monocytes greater than 7/mm^3 in the cerebrospinal fluid
- No available 5/6 or 6/6 HLA-matched related donor
PATIENT CHARACTERISTICS:
Age
- 55 and under (over 18 closed to accrual)
Performance status
- Karnofsky 70-100% OR
- Lansky 50-100% (patients under 16 years old)
Life expectancy
- Not specified
Hematopoietic
- See Disease Characteristics
Hepatic
- SGOT less than 5 times upper limit of normal
- Bilirubin less than 2.5 mg/dL
Renal
- Creatinine normal for age OR
- Creatinine clearance or glomerular filtration rate greater than 50% of lower limit of normal
Cardiovascular
- LVEF greater than 40% at rest and must improve with exercise* OR
- Shortening fraction greater than 26%* NOTE: *If symptomatic
Pulmonary
- DLCO greater than 45% of predicted* (corrected for hemoglobin)
- FEV_1 and FEC greater than 45% of predicted (corrected for hemoglobin) OR
- Room air oxygen saturation greater than 85%* NOTE: *If symptomatic
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled viral, bacterial, or fungal infection
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- More than 12 months since prior allogeneic stem cell transplantation with cytoreductive preparative therapy
- More than 6 months since prior autologous stem cell transplantation
Chemotherapy
- See Biologic therapy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior enrollment on this study
- No continuous life support (e.g., mechanical ventilation) within 1 year after study transplantation (for patients with inborn errors of metabolism)
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
Medical City Dallas Hospital
Dallas, Texas, 75230
Children's Medical Center of Dallas
Dallas, Texas, 75235
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Spectrum Health and DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
North Shore University Hospital
Manhasset, New York, 11030
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6310
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
Children's Hospital of Orange County
Orange, California, 92868
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Texas Transplant Institute
San Antonio, Texas, 78229
Children's Medical Center, University of California San Francisco
San Francisco, California, 94143-1278
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104-1095
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation
RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
Read the detailed description
OBJECTIVES:
- Determine 180-day survival in patients with malignant or nonmalignant hematologic diseases treated with allogeneic umbilical cord blood transplantation. (Severe aplastic anemia, Fanconi anemia, and marrow failure syndromes strata are closed to accrual; adult [over 18 years of age] patient stratum is closed to accrual.)
- Determine disease-free and long-term survival in patients treated with this regimen.
- Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and red blood cell engraftment in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the incidence of complications, including infection, veno-occlusive disease, and interstitial pneumonitis, in patients treated with this regimen.
- Determine the incidence of relapse, other malignancies, lymphoproliferative disorders, and posttransplantation myelodysplasia in patients treated with this regimen.
- Determine the immune reconstitution in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are grouped according to the following strata:
- Stratum I: Malignant disease, 5/6 or 6/6 HLA match, age 18 and under
- Stratum II: Malignant disease, 4/6 HLA match, age 18 and under
- Stratum III: Malignant disease, 3/6 HLA match, age 18 and under
- Stratum IV: Malignant disease, 2/6 or 1/6 HLA match, age 18 and under
- Stratum V (closed to accrual): Severe aplastic anemia, Fanconi anemia, or other marrow failure syndrome
- Stratum VI: Inborn errors of metabolism/storage diseases and other nonmalignant diseases not included in stratum V
- Stratum VII: Malignant disease receiving alternative conditioning regimen comprising busulfan and melphalan
- Stratum VIII (closed to accrual): Adult patients (over age 18)
- Conditioning therapy: Patients are assigned to 1 of 5 groups according to diagnosis.
- Group I (malignant disease or severe aplastic anemia [severe aplastic anemia closed to accrual]): Patients undergo total body irradiation (TBI) once or twice daily on days -8 to -4. Patients then receive cyclophosphamide IV on days -3 and -2, methylprednisolone IV on days -3 to 0, and antithymocyte globulin (ATG) IV once or twice daily on days -3 to -1.
- Group II (Fanconi anemia [closed to accrual]): Patients undergo TBI on day -6, and then receive cyclophosphamide IV and fludarabine IV on days -5 to -2, and methylprednisolone IV and ATG IV on days -5 to -1.
- Group III (inborn errors of metabolism/storage disease): Patients receive oral busulfan 4 times daily on days -9 to -6, cyclophosphamide as in group II, and methylprednisolone and ATG as in group I.
- Group IV (other nonmalignant diseases): Patients receive conditioning therapy as in group III. Patients with familial erythrophagocytic lymphohistiocytosis or Langerhans cell histiocytosis also receive etoposide on days -5 to -3.
- Group V (non-TBI regimen for leukemia patients under 2 years of age): Patients receive oral busulfan 4 times daily on days -8 to -5, melphalan IV on days -4 to -2, and methylprednisolone and ATG as in group I.
- Allogeneic umbilical cord blood transplantation: All patients undergo umbilical cord blood transplantation on day 0. Beginning on day 0 or 1, patients receive filgrastim (G-CSF) IV or subcutaneously daily until blood counts recover.
- Graft-versus-host disease prophylaxis: Patients receive cyclosporine (IV or oral) beginning between days -3 and -1 and continuing for 1 year after transplantation and methylprednisolone twice daily beginning on day 1 and continuing until blood counts recover.
Patients are followed weekly for 14 weeks, at 100 days, and at 4, 5, 6, 9, 12, 18, 24, and 36 months.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
- Being tested
- anti-thymocyte globulin, filgrastim, busulfan, cyclophosphamide, cyclosporine
- Keywords
- refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, acute undifferentiated leukemia, recurrent/refractory childhood Hodgkin lymphoma, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent childhood small noncleaved cell lymphoma, untreated childhood acute lymphoblastic leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies
- Medical subject headings
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Anemia, Refractory, with Excess of Blasts, Anemia, Refractory, Leukemia, Myelomonocytic, Chronic, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulinBiological
filgrastimBiological
busulfanDrug
cyclophosphamideDrug
cyclosporineDrug
melphalanDrug
umbilical cord blood transplantationProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startJan 2003
- Primary completionSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Philip L. McCarthy, MD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055653
- Sponsor's protocol ID
- CDR0000270487
- Other IDs
- RPCI-DS-00-22
- Status last verified
- Mar 2011
- First submitted
- 6 Mar 2003
- Last updated
- 7 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation
- ClinicalTrials.gov ID
- NCT00055653
- Acronym / sponsor ID
- CDR0000270487
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases
- Keywords
- refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia, chronic myelomonocytic leukemia, childhood acute myeloid leukemia in remission, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2003
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 7 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Umbilical cord blood transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
Detailed description
OBJECTIVES:
- Determine 180-day survival in patients with malignant or nonmalignant hematologic diseases treated with allogeneic umbilical cord blood transplantation. (Severe aplastic anemia, Fanconi anemia, and marrow failure syndromes strata are closed to accrual; adult [over 18 years of age] patient stratum is closed to accrual.)
- Determine disease-free and long-term survival in patients treated with this regimen.
- Determine the incidence of neutrophil engraftment, primary and secondary graft failure, platelet engraftment, and red blood cell engraftment in patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen.
- Determine the incidence of complications, including infection, veno-occlusive disease, and interstitial pneumonitis, in patients treated with this regimen.
- Determine the incidence of relapse, other malignancies, lymphoproliferative disorders, and posttransplantation myelodysplasia in patients treated with this regimen.
- Determine the immune reconstitution in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are grouped according to the following strata:
- Stratum I: Malignant disease, 5/6 or 6/6 HLA match, age 18 and under
- Stratum II: Malignant disease, 4/6 HLA match, age 18 and under
- Stratum III: Malignant disease, 3/6 HLA match, age 18 and under
- Stratum IV: Malignant disease, 2/6 or 1/6 HLA match, age 18 and under
- Stratum V (closed to accrual): Severe aplastic anemia, Fanconi anemia, or other marrow failure syndrome
- Stratum VI: Inborn errors of metabolism/storage diseases and other nonmalignant diseases not included in stratum V
- Stratum VII: Malignant disease receiving alternative conditioning regimen comprising busulfan and melphalan
- Stratum VIII (closed to accrual): Adult patients (over age 18)
- Conditioning therapy: Patients are assigned to 1 of 5 groups according to diagnosis.
- Group I (malignant disease or severe aplastic anemia [severe aplastic anemia closed to accrual]): Patients undergo total body irradiation (TBI) once or twice daily on days -8 to -4. Patients then receive cyclophosphamide IV on days -3 and -2, methylprednisolone IV on days -3 to 0, and antithymocyte globulin (ATG) IV once or twice daily on days -3 to -1.
- Group II (Fanconi anemia [closed to accrual]): Patients undergo TBI on day -6, and then receive cyclophosphamide IV and fludarabine IV on days -5 to -2, and methylprednisolone IV and ATG IV on days -5 to -1.
- Group III (inborn errors of metabolism/storage disease): Patients receive oral busulfan 4 times daily on days -9 to -6, cyclophosphamide as in group II, and methylprednisolone and ATG as in group I.
- Group IV (other nonmalignant diseases): Patients receive conditioning therapy as in group III. Patients with familial erythrophagocytic lymphohistiocytosis or Langerhans cell histiocytosis also receive etoposide on days -5 to -3.
- Group V (non-TBI regimen for leukemia patients under 2 years of age): Patients receive oral busulfan 4 times daily on days -8 to -5, melphalan IV on days -4 to -2, and methylprednisolone and ATG as in group I.
- Allogeneic umbilical cord blood transplantation: All patients undergo umbilical cord blood transplantation on day 0. Beginning on day 0 or 1, patients receive filgrastim (G-CSF) IV or subcutaneously daily until blood counts recover.
- Graft-versus-host disease prophylaxis: Patients receive cyclosporine (IV or oral) beginning between days -3 and -1 and continuing for 1 year after transplantation and methylprednisolone twice daily beginning on day 1 and continuing until blood counts recover.
Patients are followed weekly for 14 weeks, at 100 days, and at 4, 5, 6, 9, 12, 18, 24, and 36 months.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-thymocyte globulin | Biological | – |
| filgrastim | Biological | – |
| busulfan | Drug | – |
| cyclophosphamide | Drug | – |
| cyclosporine | Drug | – |
| fludarabine phosphate | Drug | – |
| melphalan | Drug | – |
| methylprednisolone | Drug | – |
| umbilical cord blood transplantation | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip L. McCarthy, MD study chair
Roswell Park Cancer Institute
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anti-thymocyte globulin, filgrastim and busulfan in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2011.