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Clinical Trial 18766

Cancer Type: Malignant Hematology
Interventions:Cellcept (Mycophenolate Mofetil); Mycophenolate Mofetil; Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus; busulfan; cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Prevention
Phase of Study: Phase II
Investigators:

  • Ernesto Ayala

Overview

Study Title

A Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haploidentical Peripheral Blood Stem Cell Transplantation

Summary

The purpose of this study is to find out if a combination of drugs (these are called: cyclophosphamide, sirolimus, and mycophenolate mofetil) will protect participants better against graft vs. host disease (GVHD) after receiving a hematopoietic cell transplant from a related partially matched (haploidentical) donor. As part of the treatment for their blood cancer, participants need a hematopoietic cell transplantation (HCT) to improve their chances of cure. In any HCT, after the stem cell infusion is given, a combination of drugs is needed to prevent GVHD and facilitate acceptance of the graft.

Objective

Primary objective is to estimate the cumulative incidence of grade II-IV acute GVHD by day 100 after related haploidentical peripheral blood stem cell transplantation using the GVHD prophylaxis regimen PTCy, sirolimus and mycophenolate mofetil. Secundary objectives are: - To determine the cumulative incidence of chronic GVHD by 1 year. - To examine additional transplantation outcomes including malignancy relapse, overall survival, progression-free survival, non-relapse mortality, and engraftment and immune reconstitution. - To examine peripheral blood markers of immune tolerance development. - To evaluate the impact of the use of haploidentical related donors in the access of ethnic/race minority patients to allogeneic transplantation.

Inclusion Criteria

Patient Participants:

  • Age: Must be older than 18 years, no upper age limit.
  • Karnofsky performance status: Full intensity conditioning, 80-100%; reduced intensity conditioning, 60-100%.
  • Vital organ function: a) Cardiac: Left ventricular ejection fraction must be > 45% assessed by multigated acquisition (MUGA) scan or echocardiogram. No myocardial infarction within 6 months of transplant evaluation. b) Pulmonary: FEV1, FVC, and adjusted diffusing capacity of the lungs for carbon monoxide (DLCO) must be ≥ 50% of predicted values. c) Liver: Transaminases (AST, ALT) less than 2 times upper limit of normal values. d) Kidney: Estimated creatinine clearance ≥ 50 cc/min.
  • Signed informed consent.
  • Included disease conditions and remission status: a) Acute leukemia in First Complete Remission (CR1) or second/subsequent CR. b) Chronic myeloid leukemia, primary myelofibrosis, chronic myelomonocytic leukemia. c) Int-2 or high risk MDS. d) Hodgkin lymphoma beyond CR1 with chemosensitive disease, Stable Disease (SD) may be included if no mass >3 cm. e) Non-Hodgkin lymphoma in high risk CR1 or subsequent CR (by clinical, cytogenetic or molecular criteria), PIF or relapsed with chemosensitive disease. SD may be included if no mass >3 cm. f) Multiple myeloma in CR/Very Good Partial Response (VGPR). Donor Participants:
  • Per Moffitt Cancer Center (MCC) Blood and Marrow Transplant (BMT) program practices, an allele level matched (8/8 HLA A, B, C and DR) sibling or unrelated donor is preferred. If a matched donor is not found, mismatched unrelated or haploidentical donors may be considered.
  • If a haploidentical donor is considered, parents, children, full siblings and in selected cases, extended family, will have high resolution typing at the MCC HLA laboratory. A familiar haploidentical donor is chosen among those who share at least one HLA-A, B, C, DRB1 and DQB1 haplotype with the patient.
  • Patient will be screened for antibodies targeting mismatched HLA antigens in potential haploidentical donors (donor specific antibodies, DSA). Antibody screen and confirmatory testing using Luminex single antigen-bead test will be done.
  • Among several potential donors, will choose in order of priority: a) Matched CMV IgG serologic status between donor and recipient. b) ABO-matched donor preferred, then minor ABO mismatch, then major ABO mismatch. c) Younger donor preferred: child, then sibling, and then parent. d) For male recipient, male donor will be preferred. Avoid mother as a donor unless no other choices.

    • Exclusion Criteria

    Patient Participants:

  • Active bacterial, viral, fungal infection not controlled with appropriate antimicrobial therapy.
  • History of HIV infection.
  • HCT co-morbidity index with total score > 3.28 Adjusted DLCO will not be included in assessment of pulmonary risk, excepting those with DLCO less than 50% which will be excluded.
  • Prior allogeneic HCT.
  • Unwilling to comply with study requirements.
  • Active, progressive or advanced disease based on diagnosis.

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