A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

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Brief Title

A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

Official Title

A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas

Brief Summary

      This is a phase I study designed to determine the feasibility of transplantation using a
      novel transplant approach that employs a two-stage haploidentical cell infusion following
      myeloablative conditioning. This strategy, which includes selective depletion of naïve T
      cells, may speed immune reconstitution thereby potentially reducing the limitations of
      traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its
      potential therapeutic application. Additionally, the investigators intend to explore overall
      survival, event-free survival, hematopoietic cell recovery and engraftment as well as
      infection rates and complications in these patients.
    

Detailed Description

      Twelve participants and 12 donors will be enrolled on this study. Donors will undergo seven
      days of hematopoietic stem cell (HSC) mobilization followed by two apheresis collections.
      Each apheresis collection will be processed by the CliniMACS system.

      DONORS: A mobilization regimen of granulocyte colony stimulating factor (G-CSF) will be used
      to obtain a peripheral blood stem cell (PBSC) product from the donor. Apheresis will be
      performed for a minimum of two consecutive days, including one day for each cell product
      delivered.

      STUDY PARTICIPANTS: Participants will undergo a two-stage haploidentical cell infusion
      following myeloablative conditioning. The first cell infusion will be a CD3-depleted product
      and the second infusion will be a CD45RA-depleted product.

      Primary Objective:

        -  To determine the feasibility of haploidentical HSCT using two infusions engineered by
           negative selection on the Miltenyi CliniMACS system- the first by selective depletion of
           CD3+ cells, followed by a second depleted of CD45RA+ cells, in children with relapsed or
           refractory solid tumors or lymphomas.

      Secondary Objectives:

        -  To estimate hematopoietic cell recovery and engraftment rates for the patients.

        -  To estimate infection rates and complications.

        -  To estimate the one-year overall survival (OS) and event-free survival (EFS) for the
           study patients.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Feasibility of haploidentical HSCT

Secondary Outcome

 hematopoietic cell recovery and engraftment rates

Condition

Ewing Sarcoma

Intervention

alemtuzumab

Study Arms / Comparison Groups

 Treatment
Description:  Participants to undergo transplantation. They receive alemtuzumab, fludarabine, sirolimus, busulfan, melphalan, and stem cells.
Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy.
Cells for infusion are prepared using the CliniMACS System.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

23

Start Date

August 20, 2012

Completion Date

February 10, 2020

Primary Completion Date

February 10, 2020

Eligibility Criteria

        Inclusion Criteria - Transplant Recipients:

          -  At least 2 years of age and less than or equal to 21 years of age.

          -  Histologically confirmed solid tumor or lymphoma at original diagnosis:

               -  Ewing Sarcoma Family of Tumors (ESFT)

               -  Gastrointestinal tumors

               -  Germ Cell tumors

               -  Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma)

               -  Lymphoma (including Hodgkin and non-Hodgkin lymphoma)

               -  Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and
                  renal cell carcinoma)

               -  Melanoma

               -  Neuroblastoma

               -  Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft
                  tissue sarcoma)

          -  Malignancy has no reasonable expectation of cure with available alternative salvage
             therapy.

          -  Has a suitable human leukocyte antigen (HLA) haploidentical donor available.

          -  At least two weeks since receipt of any biological therapy, chemotherapy, and/or
             radiation therapy.

          -  Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute
             non-hematologic toxicities from prior therapy per the judgment of the PI.

          -  Shortening fraction greater than or equal to 25%.

          -  Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50
             mL/min/1.73 m2.

          -  Pulse oximetry greater than or equal to 92% on room air

          -  Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3
             times the upper limit of the institution-established normal range.

          -  Direct bilirubin less than or equal to 3.0 mg/dL.

          -  Karnofsky or Lansky performance score of greater than or equal to 50.

        Exclusion Criteria - Transplant Recipients:

          -  Newly diagnosed patients with no prior attempt at curative therapy.

          -  Any primary or active central nervous system (CNS) malignancy, including metastatic
             disease.

          -  Any active or prior malignant or pre-malignant condition of the bone marrow, excluding
             metastasis of the primary malignancy.

          -  Prior allogeneic hematopoietic stem cell transplant.

          -  Prior autologous stem cell transplant within previous 3 months.

          -  Allergy to murine products or positive human anti-mouse antibody (HAMA).

          -  (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted
             within 7 days prior to enrollment).

          -  (Female only) Breast feeding.

        Inclusion Criteria - Donors:

          -  At least 18 years of age.

          -  Partially HLA matched family member.

          -  Human immunodeficiency virus (HIV) negative.

        Exclusion Criteria - Donors:

          -  (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted
             within 7 days prior to enrollment).

          -  (Female only) Breast feeding.
      

Gender

All

Ages

2 Years - 21 Years

Accepts Healthy Volunteers

No

Contacts

Brando Triplett, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01625351

Organization ID

RADIANT

Secondary IDs

NCI-2012-00588

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 CURE Childhood Cancer, Inc.

Study Sponsor

Brando Triplett, MD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

October 2020