Symptoms and General Pathology

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All Drugs and Chemicals

Antineoplastic Agents

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Anti-Infective Agents

Tacrolimus

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Mycophenolic Acid

Busulfan

Immunologic Factors

Immunosuppressive Agents

Mesna

Antineoplastic Agents, Alkylating

Alkylating Agents

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Antitubercular Agents

Patients receive:

* Busulfan (≥ 9 mg/kg total dose) IV or PO on days -6 to -3
* Fludarabine (150 mg/m2 total dose) IV on days -6 to -2

Patients receive a peripheral blood stem cell (PBSC) graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Fludarabine (90 mg/m2 total dose) IV on days -7 to -5
* Total body irradiation (TBI) (1200 cGy total dose) on days -4 to -1

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Fludarabine (120-180 mg/m2 total dose) IV on days -6 to -2
* Busulfan (less than or equal to 8 mg/kg PO or 6.4 mg/kg IV) on days -5 and -4

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Fludarabine (120-180 mg/m2 total dose) IV on days -7 to -3
* Melphalan (100-140 mg/m2) IV on day -1

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Fludarabine (150 mg/m2 total dose) IV on days -6 to -2
* Cyclophosphamide (29-50 mg/kg) IV on days -6 and -5
* TBI (200 cGy) on day -1

Patients receive a PBSC graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Busulfan (dosed by age and weight per institutional standards to target goal pharmacokinetic (PK) in range noted in protocol.) on days -6 to -3
* Cyclophosphamide (100 mg/kg total dose) IV on days -2 and -1

Patients receive a bone marrow (BM) graft infusion from a mismatched unrelated donor on Day 0.

Patients receive:

* Cyclophosphamide (100 mg/kg total dose) IV on days -5 and -4
* TBI (1200 cGy total dose) on days -3, -2 and -1

Patients receive a BM graft infusion from a mismatched unrelated donor on Day 0.

Given IV or PO pre-transplant as part of conditioning regimen

Given IV pre-transplant as part of conditioning regimen

Administered pre-transplant as part of conditioning regimen

Total-body irradiation

Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.

PBSC Hematopoietic Stem Cell Transplantation (HSCT)

Bone marrow graft is infused from a mismatched unrelated donor on Day 0.

Bone Marrow Hematopoietic Stem Cell Transplantation

Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.

Post-transplant Cyclophosphamide

Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.

Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body weight (IBW) starting on Day +5 post-transplant with taper recommended at 90-100 days post HCT.

Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO from Day +5 to Day +35 post-transplant.

Mycophenolate Mofetil

Survey assessments will be administered to study participants pre- and post-transplant.

Patient-Reported Outcomes

Sarah Smith, RN, BSN

Erin Leckrone

Monzr Al Malki, MD

Aaron Logan, MD

Sally Arai, MD

Alireza Eghtedar, MD

Zenia Al-Mansour, MD

Antonio M Jimenez Jimenez, MD

Farhad Khimani, MD

Muna Qayed, MD

Amelia Langston, MD

Kehinde Adekola, MD

Satyajit Kosuri, MD

Nancy Hardy, MD

Javier Bolanos Meade, MD

Zheng (Frank) Zhou, MD

Mahasweta Gooptu, MD

Dipenkumar Modi, MD

William Hogan, MD

Ramzi Abboud, MD

Philip McCarthy, MD

Ran Reshef, MD

Brian Shaffer, MD

Katarzyna Jamieson, MD

Ruby Khoury, MD

Karilyn Larkin, MD

Hannah Choe, MD

Rachel Cook, MD

Alison Loren, MD

Usama Gergis, MD

Michelle Hudspeth, MD

Jeremy Pantin, MD

Haydar Frangoul

Bhagirathbhai Dholaria, MD

Aravind Ramakrishnan

George Carrum

Jose Carlos Cruz, MD

Karen Ballen, MD

John McCarty, MD

Aric Hall, MD

Medhi Hamadani, MD

Steven Devine, MD

This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies.

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide for Patients With Hematologic Malignancies

Defined as graft failure, relapse or progression of underlying disease, death, grade 3-4 acute GVHD, or NIH-severe chronic GVHD.

Defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, or death by any cause.

Defined as relapse or progression of underling disease, graft failure, grade III-IV acute GVHD, NIH moderate or severe chronic GVHD, or death by any cause.

Defined as neutrophil count ≥500/mm\^3 for 3 consecutive days post-HCT.

Defined as the evaluation of the time it takes for neutrophil count recovery to occur in the study subjects.

Defined as platelet count ≥20,000/mm\^3 or ≥50,000/mm\^3 with no platelet transfusions within seven days.

Defined as the evaluation of the time it takes for platelet count recovery to occur in the study subjects.

Strata 2 and 3 only. Percent of donor chimerism via peripheral blood

Overall incidence of CRS of any grade and grade 3 or 4 CRS post-transplant

To tabulate adverse events (AEs) experienced by recipients, defined as grade 3-5 unexpected and Grade 5 expected AEs, according to CTCAE version 5.0.

National Marrow Donor Program

Center for International Blood and Marrow Transplant Research

Spots Global Cancer Trial Database for bone marrow hematopoietic stem cell transplantation