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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

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ClinicalTrials.gov Identifier: NCT01818479
Recruitment Status : Terminated (Trial discontinued due to low accrual.)
First Posted : March 26, 2013
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
High Risk Hematologic Malignancies Biological: stem cell transplant Procedure: Stem cell transplant Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 12, 2013
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: All participants Biological: stem cell transplant
Open label, dose finding trial with two treatment regimens, Busulfan and TBI with four dose escalation cohorts, to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells.

Procedure: Stem cell transplant



Primary Outcome Measures :
  1. Rate of acute GVHD [ Time Frame: 36 months ]
    Rate of acute GVHD grade III-IV at Day +100 post transplant


Secondary Outcome Measures :
  1. Rate of Engraftment [ Time Frame: 36 months ]
    Day +28 and +100 neutrophil engraftment

  2. Survival at Day 100 [ Time Frame: 36 months ]
    Day +100 and one year survival Day +100 and one year transplant related mortality Day +100 and one year relapse rates



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ITD, in first or subsequent complete remission (CR).

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

4c. Subjects in 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).

5. Acute lymphoblastic leukemia (ALL) with one of the following criteria: 5a. Second or subsequent CR 5b. Any PR (no circulating blasts) 5c. High-risk ALL in first CR including (Ph+, t(4:11), complex karyotype, hypodiploidy (<44 chromosomes), or positive MRD after induction 6. Myelodysplasia, intermediate -2 (score 1.5-2.0) or high risk (score >2.5) by the International Prognostic Score System.

7. Myeloproliferative Disorders (include CMML, 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 HCT, chemo-refractory disease 9d. Multiple myeloma: per NCCN guidelines. Updated annually at: www.nccn.org 10. No suitable HLA-identical sibling donor. 11. No identified 8/8 (based upon A, B, C, 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.

14. 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<40% 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 > 2.0, ALT> 2.5 X 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818479


Locations
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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Michael Boyer, MD Huntsman Cancer Institute

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01818479     History of Changes
Other Study ID Numbers: HCI61077
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Neoplasms
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists