Leukemia, Myeloid, AcutePhase 2/3NCT01015742
Unrelated Double Umbilical Cord Blood Units Transplantation
A Phase 2/3 study testing Stem cell Transplantation in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis. Read more about this study
- Who is it for?
- Ages 1 year to 50 years
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid, Chronic
- What is being tested?
- Stem cell Transplantation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Nov 2009to Jan 2013
- Phase
- Phase 2/3
- 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 1 year to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hematologically \& Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission
- Aged 1 year to 50 years
- Absence of HLA compatible related or other related donor.
- Availability of suitable UCB units.
- karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100
- Adequate renal function defined as:Serum creatinine <1.5 x normal,
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- Adequate liver function defined as:Total bilirubin <1.5 x normal, or SGOT (AST) or SGPT (ALT) <3.0 x normal
- Adequate cardiac function defined as: Ejection fraction >50% by echocardiogram.
- Adequate pulmonary function defined as:Uncorrected DLCO 50% by pulmonary function test.For children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air
Who cannot join
- Age: < 1year or > 50 year
- Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor
- karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80
- HIV positive patients.
- Female patients who are pregnant or breast feeding
- Life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
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- Serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
- Serious psychiatric/ psychological disorders
- Absence of /inability to provide informed consent
- Clinical or Paraclinical evidence of CNS or PNS involvement
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Hematology-Oncology & SCT Research Center
Tehran, Tehran Province, 14114
Amir Ali Hamidieh, MD, 84902645 ext. +98-21, aahamidieh@sina.tums.ac.ir
Ardeshir Ghavamzadeh, MD
About this study
Official title: Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.
- Being tested
- Stem cell Transplantation
- Keywords
- AML, ALL, CML
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell TransplantationDrug
Busulfan: 3.2 mg/kg IV daily on days -7 to -4
Cyclophosphamide : 60 mg/m² daily on days -3 to -2
Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2
Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90
Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Stem cell Transplant using two unrelated umbilical cord blood units. Receives: Drug: Stem cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
Measured: Until end of study
Secondary outcomes (4)
Neutrophil and platelet engraftment
Measured: 1 year
Severity of acute graft-vs-host disease(GvHD
Measured: 1 year
Early transplant related mortality
Measured: 100 days
Overall and disease free survival at one years
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Ali Hamidieh, MD, Principal investigator, Hematology-Oncology and SCT Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015742
- Sponsor's protocol ID
- HORCSCT-0902
- Status last verified
- May 2012
- First submitted
- 17 Nov 2009
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01015742
- Acronym / sponsor ID
- HORCSCT-0902
- Keywords
- AML, ALL, CML
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 18 Nov 2009 (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.
The purpose of this study is to determine the safety and feasibility of unrelated double umbilical cord blood units Transplantation in patients with haematological malignancies using Antithymocyte Globulin Cyclophosphamide, busulfan as conditioning and cyclosporin, methylprednisolone as GVHD prophylaxis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Stem cell TransplantationStem cell Transplant using two unrelated umbilical cord blood units. |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Hematologically \& Histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in Remission
- Aged 1 year to 50 years
- Absence of HLA compatible related or other related donor.
- Availability of suitable UCB units.
- karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100
Key exclusion criteria (10 listed)
- Age: < 1year or > 50 year
- Patients with an available 5-6/6 HLA-A, -B, -DRB1 matched sibling or other related donor
- karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80
- HIV positive patients.
- Female patients who are pregnant or breast feeding
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 |
|---|---|---|
| Stem cell TransplantationBusulfan: 3.2 mg/kg IV daily on days -7 to -4 Cyclophosphamide : 60 mg/m² daily on days -3 to -2 Rabbit Thymoglobulin 2.5mg/kg IV daily on days -3 to -2 Cyclosporin will begin on day -2 (IV or oral) for at least 180 days. Target trough level for cyclosporin is 200 ng/ml. In the absence of GVHD, Cyclosporin tapering will begin on day +90 Methyl prednisolone (1mg/kg/d IV) will begin on day -2 to +7 and then 0.5mg/kg until +14 posttransplant. | Drug | Experimental |
Primary outcome
To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies
Time frame: Until end of study
4 secondary outcomes
Neutrophil and platelet engraftment
Time frame: 1 year
Severity of acute graft-vs-host disease(GvHD
Time frame: 1 year
Early transplant related mortality
Time frame: 100 days
Overall and disease free survival at one years
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2012.
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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.
Amir Ali Hamidieh, MD principal investigator
Hematology-Oncology and SCT Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stem cell Transplantation in people with Leukemia, Myeloid, Acute and Leukemia, Lymphoblastic, Acute, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ardeshir Ghavamzadeh, MD (84902635 ext. +98-21, ghavamza@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the Benefit and Side Effects of Double Umbilical Cord Blood Units Stem Cell Transplantation in Hematologic Malignancies (time frame: Until end of study). It is what the study was designed to measure, not a finding.
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 4 Jun 2012.