RECRUITING

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

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Conditions

AML

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.

Official Title

A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease

Quick Facts

Study Start:2025-07-22
Study Completion:2030-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06973668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 65 and \< 75 years are eligible if they have one of the following diseases.
  2. 1. Acute Myeloid Leukemia
  3. 2. Myelodysplastic syndrome
  4. 3. Chronic myelomonocytic leukemia
  5. 2. Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor.
  6. 3. Peripheral blood stem cells as a graft source
  7. 4. Subject must voluntarily sign an informed consent.
  8. 5. Adequate organ function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN - Bilirubin \<1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin) - Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 40 mL/min/1.73 m2 (as reported in epic using 2021 CKD-EPI creatinine equation)
  9. * DLCO ≥ 50% of predicted
  10. * Ejection Fraction ≥ 50%
  11. * The effects on the developing human fetus are unknown. For this reason and as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  12. * Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  13. * History of hysterectomy or bilateral salpingo-oophorectomy.
  14. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  15. * History of bilateral tubal ligation or another surgical sterilization procedure.
  1. 1. Subject is known to be positive for HIV.
  2. 2. Subject has acute promyelocytic leukemia.
  3. 3. Subject has known active CNS involvement with AML.
  4. 4. Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of \>5
  5. 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
  6. 1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
  7. 2. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or subjects with positive anti-HBc antibody but negative Hep B DNA may participate.
  8. 6. Cardiac history of CHF requiring treatment or Ejection Fraction \< 50% or unstable angina or MI within 1 year of study entry
  9. 7. Major Adverse Cardiac Events such as MI/Stroke and PE/DVT within 6 months
  10. 8. Current and/or history of active TB
  11. 9. White Blood Cell count \> 25 X 109 /L.
  12. 10. Pregnant women are excluded from this study because the study agent has unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study agent. These potential risks may also apply to other agents used in this study.

Contacts and Locations

Study Contact

Uday Popat, MBA,MD
CONTACT
(713) 563-0812
upopat@mdanderson.org

Principal Investigator

Uday Popat, MBA,MD
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Uday Popat, MBA,MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-22
Study Completion Date2030-01-31

Study Record Updates

Study Start Date2025-07-22
Study Completion Date2030-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • AML