Clinical Trials

Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. Talk to your health care providers first before making decisions about participation in a clinical trial.

CURRENTLY ENROLLING PATIENTS

(FHCRC Protocol 2603): Multi-center, open-label randomized study of single or double myeloablative cord blood transplantation with or without infusion of off-the-shelf, ex vivo expanded, cryopreserved cord blood progenitor cells in patients with hematologic malignancies

Males/Females ages 6 months to 45 years

All patients on this trial are patients with hematologic malignancies who undergo a myeloablative cord blood transplant. Eligible patients are randomized to receive non-HLA matched cryopreserved expanded cord blood progenitor cells in addition to their cord blood transplant (experimental arm) or to undergo conventional cord blood transplant without the addition of the expanded cell graft (standard of care arm).  This study will compare the time to neutrophil and platelet recovery, transplant related mortality, incidence and severity of acute graft versus host disease, incidence of infections, and overall survival rates in the two arms.

For more information please click here.

(FHCRC Protocol 2584): Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients with AML or Acute Leukemia of Ambiguous Lineage

Males/Females ages 6 months to 30 years

The primary purpose of this pilot study is to determine whether giving non-HLA matched cryopreserved expanded cord blood progenitor cells (our universal donor progenitor cell therapy) is safe after administration of FLAG consolidation or reinduction chemotherapy in children and young adult patients. This trial is for patients with AML or Acute Leukemia of Ambiguous Lineage.

For more information please click here.

 

COMPLETED TRIALS

(FHCRC Protocol 2044): A Pilot Study to Evaluate the Co-infusion of Ex Vivo Expanded Umbilical Cord Blood Progenitors with an Unmanipulated Cord Blood Graft in Patients Undergoing Umbilical Cord Blood Transplantation for Hematologic Malignancies: A multi-center trial coordinated by the FHCRC

This trial, initiated in 2006, was the first clinical trial to use Notch-mediated ex vivo expanded cord blood stem and progenitor cells in the setting of a myeloablative double cord blood transplant. As a first-in-human study, the primary objective of this trial was safety of infusing our expanded cord blood progenitor cells. All patients on this trial underwent a cord blood transplant with two cord blood units (“double cord blood transplant), each selected on the basis of HLA-matching and cell dose. Approximately two weeks prior to transplant, one unit was thawed and the CD34+ stem cells were isolated and placed into culture. On the day of transplant, the expanded cells were then harvested and infused into the patient 4 hours after infusion of the second unmanipulated cord blood unit. There were no adverse events attributed to the expanded cell product. In addition to safety, this study also examined the time it took for recovery of blood counts (engraftment) to occur and which unit (donor) of cord blood was responsible for the blood count recovery.

Please see Delaney C, Heimfeld S, Brashem-Stein C, Voorhies H, Manger R and Bernstein ID. Notch-mediated expansion of human cord blood progenitor cells capable of rapid myeloid reconstitution. Nature Medicine, 2010 Feb;16(2):232-6, with updated data in ASH abstract: C Delaney, F Milano, I Nicoud, S Heimfeld, C Karanes, J Gutman, J Wagner, F Appelbaum, I Bernstein. Dose Dependent Enhancement of Neutrophil Recovery by Infusion of Notch Ligand Ex Vivo Expanded Cord Blood Progenitors: Results of a Multi-Center Phase I Trial. ASH Annual Meeting, December 2013.

(FHCRC Protocol 2335): Clofarabine in Combination with Cytarabine (Ara-C) and G-CSF Priming Followed by Infusion of Ex Vivo Expanded Cord Blood Progenitors for Patients with AML

The primary purpose of this study was to determine whether giving non-HLA matched cryopreserved expanded cord blood progenitor cells (our universal donor progenitor cell therapy) after intensive chemotherapy is safe in adult patients with AML. Secondary objectives were to assess the ability of the product to provide temporary myeloid engraftment, the kinetics/persistence of potential engraftment, the kinetics of autologous recovery when compared to historical cohorts, and the development of alloimmunization.

For results, please see Delaney C, Becker PS, Milano F, Nicoud IB, Heimfeld S, Riffkin I, Papermaster A, Appelbaum FR, Bernstein ID, Estey EH. Infusion of “off-the-shelf” third party ex vivo expanded cord blood progenitor cells as supportive care following clofarabine with high dose cytarabine and granulocyte colony-stimulating factor priming for the treatment of AML. ASH Annual Meeting, December, 2011

(FHCRC Protocol 2378): Infusion of off–the-shelf ex vivo expanded cryopreserved cord blood progenitor cells to augment single or double myeloablative cord blood transplantation in patients with hematologic malignancies

The primary purpose of this study was to determine whether giving non-HLA matched cryopreserved expanded cord blood progenitor cells (our universal donor progenitor cell therapy) along with one or two unexpanded cord blood units is safe and decreases the time to recovery of blood counts. The in vivo persistence of the ex vivo expanded cord blood product was also examined, as were other clinical outcomes including transplant related mortality, overall survival, relapse rates and rates of acute and chronic GVHD.

For results, please see Milano F, Heimfeld S, Riffkin I, Nicoud I, Appelbaum FR, , Bernstein ID, Delaney C. Infusion of a Non HLA-Matched Off-the-Shelf Ex Vivo Expanded Cord Blood Progenitor Cell Product following Myeloablative Cord Blood Transplantation is Safe, Decreases the Time to Hematopoietic Recovery, and Results in Excellent Overall Survival. ASH Annual Meeting, December 2014

 

Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:

  • Talk to your health care providers first before making decisions about participation in a clinical trial.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study and are detailed in the links above.