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Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies After Matched Allogeneic Hematopoietic Stem Cell Transplantation


Phase 1
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

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Trial Information

Infusion of Donor Lymphocytes Depleted of CD25+ Regulatory T-cells in Patients With Relapsed Hematologic Malignancies After Matched Allogeneic Hematopoietic Stem Cell Transplantation


- The original marrow/stem cell donor will undergo one or two white blood cell collection
procedures called leukopheresis. The cells collected from the first leukopheresis will
be sent to the laboratory where the amount of white blood cells collected will be
measured. If the number of cells collected at the first leukopheresis is not enough,
the donor will have a second leukopheresis procedure.

- Once enough lymphocytes are collected from the donor, the CliniMACS CD25 Reagent System
device will reduce the number of CD25+ Tregs. The CD25+ depleted donor lymphocytes
will then be infused to the participant intravenously. Participants will be observed
for about one hour after the infusion.

- One, two, four and eight weeks after the DLI, participants will return to the clinic
for follow-up visits. At each visit a physical exam, questions about the participants
general health, and blood tests will be performed.


Inclusion Criteria:



- Patients with hematologic malignancies that have relapsed after HLA-A, -B, -C,
and-DRBI matched allogeneic hematopoietic stem cell transplantation

- At least 2 months following hematopoietic stem cell transplantation

- Off any systemic immunosuppressive medication for treatment or prevention of GVHD,
for a minimum of 2 weeks prior to study entry

- Recipient with donor chimerism of 20% or greater within 6 weeks prior to DLI

- Patient with less than 50% bone marrow involvement (% cellularity) and less than 5cm
lymph nodes, in the 6 weeks prior to DLI

- 18 years of age or older

- ECOG Performance Status score 0-2

- Prior stem cell donor is medically fit to undergo leukapheresis procedure

Exclusion Criteria:

- Relapsed CML in chronic phase

- Prior donor lymphocyte infusion or other immunotherapy treatment within 8 weeks prior
to enrollment

- Chemotherapy within 4 weeks prior to enrollment

- Clinically significant and active autoimmune disease in donor or patient. This is
defined as autoimmune disease resulting in organ dysfunction and/or requiring
systemic therapy

- Evidence of active acute or chronic GVHD

- Uncontrolled infection

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the feasibility of using the ClinMACS CD25 Reagent device to engineer a DLI product outlined in the protocol

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

John Koreth, MBBS, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

07-193

NCT ID:

NCT00675831

Start Date:

December 2007

Completion Date:

January 2013

Related Keywords:

  • Hematologic Malignancies
  • CD25+
  • Tregs
  • DLI
  • Donor lymphocyte infusion
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Dana-Farber Cancer Institute Boston, Massachusetts  02115