Cord Blood Expansion on Mesenchymal Stem Cells
5 other identifiers
interventional
98
1 country
1
Brief Summary
The goal of this clinical research study is to learn if combining cord blood units will be safe and result in the cells "taking" faster in recipients. The cord blood units will have their cell number increased in the lab using cells from a family member or they will be collected from an unrelated healthy donor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 3, 2007
CompletedFirst Submitted
Initial submission to the registry
July 6, 2007
CompletedFirst Posted
Study publicly available on registry
July 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 28, 2020
October 1, 2016
9.3 years
July 6, 2007
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Engraftment and Time to Engraftment
Engraftment defined as a sustained ANC \> 0.5 x 109/L for 3 consecutive days and evidence of donor chimerism or autologous reconstitution by D+42
100 days after transplant, then every 3 months thereafter
Study Arms (1)
Cord Blood Infusion
OTHERCord blood transplantation performed on day 0. Busulfan 32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4. Fludarabine 10 mg/m2 by vein on Days -7 to -4, 40 mg/m2 by vein on Days -6 to -3 or on Days -5 to -2. Rituximab 375 mg/m2 by vein on Day -9. ATG 1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3, 1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2. Cyclophosphamide 50 mg/kg by vein on Day -6. Clofarabine 30 mg/m2 by vein on Days -7 to -4. Total body irradiation (TBI) 200 cGy at 25 cGy/minute delivered on Day -3. Melphalan 140 mg/m2 by vein on Day -2. Tacrolimus 0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.
Interventions
32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s). 40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy. 40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy. 1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \> 55 and \< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.
30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \>1 and \< 55 years old. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
200 cGy at 25 cGy/minute delivered on Day -3.
140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \>1 and \< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.
0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.
1 gram by vein twice a day Days -3 through Day 100.
5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is \> 2.5 x 109/L.
Eligibility Criteria
You may qualify if:
- Patients must have one of the following hematologic malignancies: Acute Myelogenous Leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics, flt3 mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from MDS, Langerhan's cell histiocytosis, any disease beyond first remission; or,
- Myelodysplastic Syndrome (MDS): Primary or therapy related; or,
- Acute Lymphoblastic Leukemia (ALL): induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease.
- #3, continued: Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease, or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma; or,
- Non-Hodgkin's Lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). Double hit lymphomas in first remission or more advanced disease; or,
- Small Lymphocytic Lymphoma (SLL), or Chronic Lymphocytic Leukemia (CLL) with progressive disease following standard therapy; or,
- CML second chronic phase or accelerated phase; or,
- Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); or,
- Multiple Myeloma: stage II or III, symptomatic, secretory Multiple Myeloma requiring treatment.
- Age greater than or equal to 1 year but less than or equal to 55 years (Myeloablative Regimen 4). Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).
- Age greater than 55 years and less than or equal to 80 years (Nonmyeloablative Regimen 2)
- Age greater than or equal to 1 but less than or equal to 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive reduced intensity regimen 3.
- Performance score of at least 60% by Karnofsky or PS less than 3 (ECOG) (age greater than or equal to 12 years), or Lansky Play-Performance Scale of at least 60% or greater (age \<12 years)
- Left ventricular ejection fraction of at least 40% (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or 30% (Nonmyeloablative Regimen 2)
- Pulmonary function test demonstrating a diffusion capacity of least 50% predicted (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or at least 40% predicted (Nonmyeloablative Regimen 2). For children \< 7 years of age who are unable to perform pulmonary function test (PFT), oxygen saturation \> 92% on room air by pulse oximetry.
- +7 more criteria
You may not qualify if:
- HIV positive
- Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding.
- Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation. (excluding primary disease for which CB transplantation is proposed), or psychiatric condition that would limit informed consent.
- Active central nervous system (CNS) disease in patient with history of CNS malignancy.
- Availability of appropriate, willing, HLA-matched related marrow donor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- ViaCellcollaborator
- National Institutes of Health (NIH)collaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
de Lima M, McNiece I, Robinson SN, Munsell M, Eapen M, Horowitz M, Alousi A, Saliba R, McMannis JD, Kaur I, Kebriaei P, Parmar S, Popat U, Hosing C, Champlin R, Bollard C, Molldrem JJ, Jones RB, Nieto Y, Andersson BS, Shah N, Oran B, Cooper LJ, Worth L, Qazilbash MH, Korbling M, Rondon G, Ciurea S, Bosque D, Maewal I, Simmons PJ, Shpall EJ. Cord-blood engraftment with ex vivo mesenchymal-cell coculture. N Engl J Med. 2012 Dec 13;367(24):2305-15. doi: 10.1056/NEJMoa1207285.
PMID: 23234514DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Shpall, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2007
First Posted
July 10, 2007
Study Start
July 3, 2007
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
February 28, 2020
Record last verified: 2016-10