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Phase I/II Study of Treg/Tcon Addback to CD34 Selected Partially Matched Related Donor Stem Cells With Myeloablative Conditioning for High Risk Hematologic Malignancies


Phase 1/Phase 2
N/A
70 Years
Not Enrolling
Both
High Risk Hematologic Malignancies

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Trial Information

Phase I/II Study of Treg/Tcon Addback to CD34 Selected Partially Matched Related Donor Stem Cells With Myeloablative Conditioning for High Risk Hematologic Malignancies


Inclusion Criteria:



1. Age 0-70 years

2. Karnofsky or Lansky Performance status >70%

3. High risk hematologic malignancy (see section 5.1)

4. No suitable HLA-identical sibling donor

5. No identified 8/8 allele matched unrelated donor, or unable to wait sufficient time
to procure a 8/8 allele matched unrelated donor

6. Available HLA 3-5/6 matched genotypically haploidentical partially matched related
donor

7. Female patients must be surgically sterile, postmenopausal (minimum 1 year without
menses), or agree to use approved form of contraception from the time of signing the
informed consent form through Day +100. Male patients must also agree to use an
approved form of birth control for either themselves or their partner, as
appropriate, from the time of signing the informed consent form through Day +100.

8. Able to provide informed consent and have signed an approved consent form that
conforms to federal and institutional guidelines.

Exclusion Criteria:

1. Available HLA identical matched sibling donor (unless having failed a prior
allogeneic transplant from an HLA identical matched sibling)

2. Recipient HLA antibodies against donor HLA

3. Any of the following organ dysfunctions:

1. Cardiac- left ventricular ejection fraction <40%, symptomatic coronary artery
disease, or uncontrolled arrhythmias

2. Pulmonary- FEV1 or DLco<50% or need for use of supplemental oxygen

3. Renal- calculated or measured GFR <30 ml/min, dialysis requirement, or prior
renal transplant

4. Hepatic- bilirubin > 2 X ULN, ALT> 2.5 X ULN, cirrhosis

4. Patients with active or uncontrolled bacterial, viral, or fungal infections requiring
systemic therapy.

5. Patients who have tested positive for HIV.

6. Pregnant women, nursing mothers or women of child-bearing potential who are unwilling
to use medically accepted methods of contraception.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of acute GVHD

Outcome Description:

Rate of acute GVHD grade II-IV at Day +100 post transplant Absolute CD4+ count at day +100

Outcome Time Frame:

36 months

Safety Issue:

Yes

Principal Investigator

Michael Boyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Huntsman Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

HCI61077

NCT ID:

NCT01818479

Start Date:

May 2013

Completion Date:

May 2016

Related Keywords:

  • High Risk Hematologic Malignancies
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Huntsman Cancer InstituteSalt Lake City, Utah  84112