Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01235468
Other study ID # SHEBA-10-7959-AN-CTIL
Secondary ID
Status Withdrawn
Phase Phase 1
First received November 2, 2010
Last updated December 1, 2015
Start date June 2012
Est. completion date November 2015

Study information

Verified date December 2015
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.


Description:

Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- age > 18 years

- hematological malignancy

- standard indication for allogeneic transplantation

- expected survival time over 12 weeks

- no related or unrelated donor

- availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status >2

- Prior allogeneic transplantation

- Pregnant or nursing women

- Positive serology for hepatitis B or C

- HIV positive

- Left ventricular ejection fraction < 50%

- DLCO < 50%

- Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study

- Treatment with other investigational drugs within 4 weeks of enrolling in this protocol

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
ex vivo expansion
ex-vivo expansion of cord blood for transplantation

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Dr. Avichai Shimoni MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Number of patients with adverse events during infusion 1 month Yes
Primary engraftment Time to engraftment 3 months Yes
Primary treatment-related toxicity Type and severity of adverse events after transplantation using the NCI CTC scale 3 months Yes
Primary GVHD Number of patients with acute and chronic GVHD after transplantation 1 year Yes
Secondary Immunological reconstruction immunological reconstruction after transplantation measured by lymphocyte number and function 5 years No
Secondary relapse rate of disease recurrence 5 years No
See also
  Status Clinical Trial Phase
Terminated NCT03248479 - Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies Phase 1
Recruiting NCT05454241 - CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies Phase 2
Recruiting NCT06041815 - Correlation Between Gut Microbiota and Clinical Response to CAR-T Treatment for Hematological Malignancies
Active, not recruiting NCT05005442 - A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004) Phase 2
Recruiting NCT02300571 - Observational Study of the Combination of Post-transplant High Dose Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Acute Graft-versus-Host Disease in Patients Eligible to Allogeneic Hematopoietic Stem Cell Transplant N/A
Active, not recruiting NCT01428973 - Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens Phase 2
Completed NCT00379587 - Rituximab for Prevention of Chronic GVHD Phase 1/Phase 2
Terminated NCT00506948 - Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD) Phase 2
Completed NCT01162096 - Reduced Intensity Haploidentical Transplant for Hematological Malignancies Phase 1/Phase 2
Active, not recruiting NCT04557098 - A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Phase 2
Recruiting NCT04283097 - Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects Phase 1
Completed NCT03067155 - CMV Specific T Cell Therapy After Allogeneic Stem Cell Transplantation. Phase 2
Completed NCT01725555 - A Study to Assess the Effect of Food on the Bioavailability of the IGF-1R Inhibitor AXL1717 in Patients With Advanced Malignant Tumors Phase 1
Completed NCT00438178 - Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies Phase 1
Completed NCT03711604 - Compassionate Use Study of Tenalisib (RP6530) Phase 1/Phase 2
Withdrawn NCT01168882 - Safety and Tolerability of RGB-286638 in Patients With Selected, Relapsed or Refractory Hematological Malignancies Phase 1
Completed NCT01246206 - Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT Phase 2
Completed NCT01172132 - The Use of Intensive Care in Critically Ill Cancer Haematological Patients: "TRIAL-OH" N/A
Completed NCT00506402 - A Phase 1 Study of MKC-1 in Patients With Refractory Hematologic Malignancies Phase 1
Active, not recruiting NCT00163644 - RCT to Investigate Whether an Exercise Programme Improves the Physical Performance and QOL After BMT N/A