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TerminatedNCT01818479Updated Aug 11, 2020

Phase I/II Study of Treg/Tcon Addback to Partially Matched Related Donor Stem Cells With Myeloablative Conditioning and Post-transplant Cyclophosphamide for High Risk Hematologic Malignancies

A Phase 1 interventional study of stem cell transplant and Stem cell transplant in High Risk Hematologic Malignancies, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by University of Utah · Phase 1, Interventional, and Treatment

Why this study was terminated
Trial discontinued prior to starting Phase II portion due to low accrual.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
Up to 70 Years
Sex
All
01

Study summary

Open label, dose finding trial to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells. The maximum tolerated dose will be established using 3 subjects per dose level, with an expansion cohort at the maximum tolerated dose.

02

Conditions studied

  • High Risk Hematologic Malignancies
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 0-70 years 2. Karnofsky or Lansky Performance status >70% 3. High risk hematologic malignancy 4. Acute myeloid leukemia (AML) with one or more of the following criteria: 4a.Poor risk cytogenetics, including -5, 5q-, -7, 7q-, t(9;22); complex cytogenetics (>3 abnormalities); or normal cytogenetics with Flt3 internal tandem duplication (ITD), in first or subsequent complete remission (CR).

4b. Relapsed or primary refractory AML with \<10% blasts in the peripheral blood.

4c. Subjects in first complete remission (CR1) who required two cycles of induction to achieve remission may be included at the discretion of the treating physician.

4d. Standard risk or intermediate risk cytogenetics in second or subsequent CR (enrolled at the discretion of the treating physician).

  1. Acute lymphoblastic leukemia (ALL) with one of the following criteria: 5a. Second or subsequent CR 5b. Any partial remission (PR) (no circulating blasts) 5c. High-risk ALL in first CR including (Ph+, t(4:11), complex karyotype, hypodiploidy (\<44 chromosomes), or positive minimal residual disease (MRD) after induction 6. Myelodysplasia, intermediate -2 (score 1.5-2.0) or high risk (score >2.5) by the International Prognostic Score System.
  1. Myeloproliferative Disorders (include chronic myelomonocytic leukemia (CMML), agnogenic myeloid metaplasia (AMM) or Idiopathic Myelofibrosis, and JMML) with excess blasts (>5%) 8. Chronic myeloid leukemia (CML) with one of the following criteria: 8a. Second or subsequent chronic phase 8b. Accelerated phase 8c. blast crisis 9. Non-Hodgkin's lymphoma (NHL) meeting one of the following criteria: 9a. Relapse after autologous stem cell transplantation with evidence of responsive disease.

9b. Subject with chemosensitive relapse who have no option for autologous stem cell transplantation due to blood or marrow involvement or failure to mobilize autologous stem cells or are not considered eligible for autologous transplant by their treating physician.

9c. Hodgkin's Lymphoma: relapse after autologous hematopoietic cell transplantation (HCT), chemo-refractory disease 9d. Multiple myeloma: per National Comprehensive Cancer Network (NCCN) guidelines. Updated annually at: www.nccn.org 10. No suitable human leukocyte antigen (HLA)-identical sibling donor. 11. No identified 8/8 (based upon A, B, C, DR beta 1 (DRB1) loci) allele matched unrelated donor, or unable to wait sufficient time to procure a 8/8 allele matched unrelated donor 12. Available HLA 3-5/6 matched genotypically haploidentical partially matched related donor 13. Female subjects 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 subjects 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.

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

Exclusion criteria

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- forced expiratory volume at one second (FEV1) or diffusion capacity of lung for carbon monoxide (DLco)\<40% or need for use of supplemental oxygen
    3. Renal- calculated or measured glomerular filtration rate (GFR) \<30 ml/min, dialysis requirement, or prior renal transplant
    4. Hepatic- bilirubin > 2.0, alanine aminotransferase (ALT) > 2.5 X upper limit of normal (ULN), cirrhosis
  4. Subjects with active or uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
  5. Subjects 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    All participants

    Biological: stem cell transplant · Procedure: Stem cell transplant

Interventions

  • Biologicalstem cell transplant

    Open label, dose finding trial with two treatment regimens, Busulfan and Total Body Irradiation (TBI) with four dose escalation cohorts, to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells.

  • ProcedureStem cell transplant
06

What researchers measure

Primary outcomes

  1. Rate of acute GVHD

    Rate of acute Graft Versus Host Disease (GVHD) grade III-IV at Day +100 post transplant

    Time frame: 36 months

Secondary outcomes

  1. Rate of Engraftment

    Day +28 and +100 neutrophil engraftment

    Time frame: 36 months

  2. Survival at Day 100

    Day +100 and one year survival Day +100 and one year transplant related mortality Day +100 and one year relapse rates

    Time frame: 36 months

07

Study locations

1 site
  • Huntsman Cancer Institute
    Salt Lake City, Utah 84112, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01818479
Lead sponsor
University of Utah
Responsible party
Sponsor
First posted
Mar 26, 2013
Start date
Jul 12, 2013
Primary completion
Apr 1, 2019
Completion
Apr 1, 2019
Last update
Aug 11, 2020

Study contacts

Michael Boyer, MD
principal investigator · Huntsman Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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