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A Phase II Trial of Primary Transplant or Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation


Phase 2
N/A
N/A
Open (Enrolling)
Both
Cytomegalovirus

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Trial Information

A Phase II Trial of Primary Transplant or Third Party Donor Derived CMVpp65 Specific T-cells for The Treatment of CMV Infection or Persistent CMV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation


Inclusion Criteria:



- Each patient must satisfy at least one of the following criteria:

1. The patient must have a clinically documented condition associated with CMV
(e.g. interstitial pneumonia, hepatitis, retinitis, colitis) Or

2. The patient must have microbiological evidence of CMV viremia or tissue invasion
as attested by viral culture, or detection of levels of CMV DNA in the blood or
body fluids consistent with CMV infection.

Patient must also satisfy at least one of the following criteria:

1. The patient's CMV infection is clinically progressing or CMV viremia is persistent or
increasing (as evidenced by quantitation of CMV DNA in the blood) despite two weeks
induction therapy with antiviral drugs.

Or

2. The patient has developed CMV viremia as attested by viral culture, or detection of
levels of CMV DNA in blood or body fluids while receiving prophylactic doses of
antiviral drugs to prevent CMV infection post transplant.

Or The patient is unable to sustain treatment with antiviral drugs due to drug associated
toxicities (e.g. myelosuppression [ANC< 1000μl/ml without GCSF support] or nephrotoxicity
[corrected creatinine clearance ≤ 60 ml/min/1.73 m2 or serum creatinine > 2 mg/dl]) CMV
infections are life threatening, and may involve multiple organ systems such as the lungs,
liver, gastrointestinal tract, hematopoietic and central nervous systems. Antiviral drugs
used for treatment may also compromise renal and hematopoietic function. Therefore,
dysfunctions of these organs will not affect eligibility for this protocol Patients must
meet the following clinical criteria to receive CMVpp65-CTL infusions

1. Stable blood pressure and circulation, not requiring pressor support

2. Evidence of adequate cardiac function as demonstrated by EKG and/or echocardiography.

3. A life expectancy of at least 3 weeks, even if requiring artificial ventilation.

4. There are no age restrictions

Exclusion Criteria:

- Patients requiring high doses of glucocorticosteroids (≥ 0.3 mg/kg prednisone or its
equivalent) 2. Patients who are moribund 3. Patients with other conditions not
related to CMV infection (e.g. uncontrolled bacterial sepsis or invasive fungal
infection) which are also life-threatening and which would preclude evaluation of the
effects of a T-cell infusion. 3.4. Patients who are pregnant 6.1.3 Donor Inclusion
Criteria 6.1.3a Donors in Group 1 (Historical Donors) Donors in Group 1 (Section 5.1)
would have already been determined to be eligible and will have donated blood or
leukocytes to establish CMV-specific T-cells under IRB # 05-065, 07-055, 95-024, or
11-130. There are no additional eligibility requirements for these donors.

6.1.3b Donors in Groups 2 & 3 (Prospective and Volunteer Donors) Transplant donors and
healthy HLA typed volunteers who agree to provide T-cells for Third-party donation
(section 5.1, Groups 2 and 3), however, will need to meet the following eligibility
requirements prior to donation:

1. Donors must satisfy the criteria specified in FDA 21 CFR 1271.

2. Donors must be typed for HLA-A, B, C and DR

3. Donors must have a hemoglobin value > 10g/dl

4. Donors must be capable of undergoing, at least, a single standard 2 blood volume
leukapheresis or a donation of one unit of whole blood 6.1.4 Donor Exclusion Criteria

1. HTLV/HIV(+) or Hepatitis B or C antigen(+) donors 2. Donors who are known CMV
seronegative

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

efficacy CMV specific T cells

Outcome Description:

The endpoint of this study is complete response, defined as the clearance of the CMV infection 3-7 weeks following completion of the last cycle of CMV CTLs. The evaluation of treatment efficacy will be assessed separately for 1) patients receiving CMV specific T cells from their transplant donor and 2) patients receiving CMV specific T cells from a matched third party donor.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Richard O'Reilly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-086

NCT ID:

NCT01646645

Start Date:

July 2012

Completion Date:

July 2015

Related Keywords:

  • Cytomegalovirus
  • CMVpp65 specific T-cells
  • Stem Cell Transplantation
  • 12-086
  • Cytomegalovirus Infections
  • Viremia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021