- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624701
Clinical Ex Vivo Expansion of Human Umbilical Cord Blood Stem and Progenitor Cells
Clinical Ex Vivo Expansion of Human Umbilical Cord Blood Stem and Progenitor Cells: A Pilot Trial in Collaboration With the Massachusetts Institute of Technology
Study Overview
Status
Intervention / Treatment
Detailed Description
- Clinical transplantation of two cord blood units: one ex vivo expanded while another unmanipulated unit to function as a back-up.
Ten patients will be selected from those for whom:
- Allogeneic haematopoietic stem cell transplant is indicated (see details)
- No matched sibling or matched unrelated donor is available quickly enough for the transplant (no fully matched donor found within 1 month of initiation of donor search or donor found but not available for donation within 3 months of donor search).
- At least three unrelated donor cord blood unit can be identified with less than 2 antigens mismatches with the patient but with insufficient cell dose to meet the patient's requirements. If clinical efficacy of this protocol is demonstrated, we will proceed to a multicentre clinical trial with more patients.
- The investigators will obtain haplo-identical MSC from the bone marrow of sibling/parent/offspring of the patient. Although there will be some MSC co-infused with the cord blood cells, this has been shown to be safe in trials of MSC given for patients with graft versus host disease (GVHD) and human leukocyte antigen (HLA) matching of MSC and recipient has been shown to be not important. bone marrow mesenchymal stroma cells (BM-MSCs) derived from related donor bone marrow with a minimum of 2/6 HLA match have been safe for use in patients.1 If the haplo-identical MSC donor is not available, matched unrelated donor MSC would also be used.
Efficacy will be assessed by the following and compared to published literature as well as historical controls:
- Neutrophil and platelet engraftment
- Post transplant 100-day mortality
- Overall and progression-free survival If clinical efficacy of this protocol is demonstrated, the investigators will proceed to a multicentre clinical trial with more patients.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 169608
- Singapore General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be from the Department of Haematology, Singapore General Hospital, who have the diagnoses listed below and who meet the inclusion criteria. They have to be deemed suitable for trial by the respective attending doctor as well as a panel of at least three hematologists. Suitability will be reassessed by the Principal Investigator again
- Patients aged 12 years to 60 years.
- Patient has no currently available HLA-A, B, C, DRB1 and DQB1 matched related or unrelated donor.
- Patient must have a hematologic malignancy requiring allogeneic haematopoietic stem cell transplantation as further defined below (from National Marrow Donor Program and American Society of Blood and Marrow Transplantation Guidelines) and as further agreed upon by a panel of at least three hematologists specializing in transplantation.
Acute myelogenous leukemia (AML): High-risk AML including:
- Antecedent hematological disease (e.g., myelodysplasia (MDS))
- Treatment-related leukemia
- Induction failure
- 1st complete remission (CR1) with poor-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23 etc)
- 2nd complete remission (CR2) and beyond
Acute lymphoblastic leukemia (ALL)
- CR1 up to age 35
- High-risk over age 35 including:
- Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)
- High white cell count (> 30,000/mm3) at diagnosis
- CNS or testicular leukemia
- No CR within 4 weeks of initial treatment
- Induction failure
- CR2 and beyond
Myelodysplastic syndromes (MDS)
- Intermediate-1 (INT-1), intermediate-2 (INT-2) or high IPSS score which includes:
- > 5% marrow blasts
- Other than good risk cytogenetics (not 5q- or normal)
- > 1 lineage cytopenia
Chronic myelogenous leukemia (CML)
- Disease progression
- Accelerated phase
- Blast crisis (myeloid or lymphoid)
Follicular lymphoma
- Poor response to initial treatment
- After second or subsequent relapse
- Transformation to diffuse large B-cell lymphoma
Aggressive T-cell or B-Cell lymphoma
- After second or subsequent relapse
- No CR with initial treatment
- Mantle Cell: After second or subsequent relapse
Hodgkin's lymphoma
- No initial CR
- After second or subsequent relapse
- Multiple myeloma: Patients failing autologous transplantation with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L may be considered for this protocol after initial therapy.
Exclusion Criteria:
Inadequate Organ Function as defined by:
- Renal: Creatinine clearance > 60ml/min
- Hepatic: Bilirubin, AST/ALT < 2x upper limit of normal
- Pulmonary function: DLCOcorr > 50% normal
- Cardiac: left ventricular ejection fraction > 45%
- Karnofsky score (adults) < 70% or Lansky score < 50% (pediatrics)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Expanded
'Ex vivo expanded cord blood cells
|
Cord blood cells will be expanded ex vivo using a combination of stem cell factor (SCF), thrombopoietin (TPO), Flt3 ligand and IGFBP2 with mesenchymal stromal cell (MSC) co-culture.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 1 month
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Number of subjects with infusional toxicities (including fever, renal dysfunction within 72 hours of infusion) and potential immunologic competition (absent chimerism of donor cells by 21 days post transplantation).
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment
Time Frame: 2 months
|
Neutrophil engraftment (ANC>500/ul) in subjects as demonstrated by number of subjects with engraftment <=21 days.
|
2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William YK Hwang, MBBS, FRCP, Singapore General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/925/B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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