Cyclophosphamide in Treating Patients with Hematological Malignancies after Undergoing Donor Stem Cell Transplant

Inclusion Criteria

• Any patient with a hematological or oncological diagnosis in which allogeneic hematopoietic stem cell transplantation (HSCT) is thought to be beneficial * Patients without morphological or molecular evidence of disease or * For patients with “indolent diseases" if the patient has evidence of disease the disease burden must be minimal (at least partial response [PR]) and the disease must be chemo-responsive; thus for example patients with acute leukemia (not an indolent disease) must be in a morphological complete response (CR) or CR with incomplete platelet recovery (CRp)
• For patients with myelodysplastic syndromes (MDS) the inclusion criteria is specifically as follows: * For patients with refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) or isolated 5q- they can proceed to transplant without any treatment * For patients with refractory anemia with excess blasts-1 (RAEB-1), refractory cytopenia with multilineage dysplasia (RCMD)+/- ringed sideroblasts (RS), or MDS not otherwise specified (NOS) must have stable disease for 6 months (as documented by serial bone marrow examinations) in the absence of any therapy but growth factors or transfusion support; patients who require treatment to "control their disease" must show chemo-responsiveness * For patients with chronic myelomonocytic leukemia (CMML) or RAEB-2 they must demonstrate chemo-responsiveness * Chemo-responsiveness is defined as a blast percentage decrease by at least 5 percentage points and there must be less than 10% blasts after treatment and at the time of transplant, if there are more than 10% blasts at any point during the disease course * Chemo-responsiveness must also include at least one of the following if applicable ** A cytogenetic response ** A well-documented decrease in transfusion requirements
• Patients must have a related donor who is zero, one, two, three, or four antigen mismatched at the HLA-A; B; C; DR loci or an unrelated donor up to a two antigen mismatch; deoxyribonucleic acid (DNA) will be retained by the tissue typing laboratory for possible typing for DQ and DP; when multiple related donor options are available donor selection will be determined the same as in the TJU two-step protocols; when multiple unrelated donors are available care will be made to avoid HLA-A and HLA-B mismatches if possible based on data from the Japanese Marrow Donor Registry studies; an HLA antibody screen will be performed on each patient; the hematopoietic progenitor cells from unrelated donors may be cryopreserved prior to infusion as circumstances require such as during the COVID-19 pandemic; recently published data has shown that cryopreservation has no adverse effect on survival
• Patients with related donors must have a left ventricular ejection fraction (LVEF) of >= 35%; patients with unrelated donors must have an LVEF >= 45%; patients with LVEF =< 50% and all patients with symptoms or history of heart failure or coronary artery disease must have a stress echocardiogram (echo) or equivalent test and a cardiological evaluation
• Patients with related donors must have a diffusion capacity of the lung for carbon monoxide (DLCO) >= 35% of predicted corrected for hemoglobin; patients with unrelated donors must have a DLCO >= 45% of predicted corrected for hemoglobin; for related donors if the DLCO is less than 45% the ejection fraction (EF) must be greater than 45% and vice versa
• Patients with related donors must have an adequate liver function as defined by:
• Serum bilirubin =< 3.0
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 X upper limit of normal
• Patients with unrelated donors must have an adequate liver function as defined by:
• Serum bilirubin =< 1.8
• AST and ALT =< 2.5 X upper limit of normal
• Exceptions may be granted for patients with “benign” liver disorders such as Gilbert’s disease
• Patients with related donors or with unrelated donors must have a creatinine clearance of >= 60 ml/min/1.73 m^2
• Patients with related donors must have a performance status >= 60% (TJU Karnofsky); patients with unrelated donors must have a performance status >= 70% (TJU Karnofsky)
• Patients with related donors must have a hematopoietic cell transplant-co-morbidity index (HCT-CI) score =< 6 points; patients with unrelated donors must have a HCT-CI score =< 5 points
• Patients must be willing to use contraception if they are of childbearing potential
• Patients must be able to give informed consent or have a care-giver who can give consent

Exclusion Criteria

• Patients with related donors who have a combination of performance status of =< 70% (TJU Karnofsky) and an HCT-CI of 4 points or more; patients with unrelated donors with a combination of performance status of =< 80% (TJU Karnofsky) and an HCT-CI of 4 points or more
• Patients with active involvement of the central nervous system with malignancy; this can be documented as an abnormal neurological exam and/or a positive cerebrospinal fluid (CSF) analysis
• Patients with a psychiatric disorder that would preclude patients from complying with the protocol even with a caregiver
• Pregnancy
• Patients with life expectancy of =< 6 months for reasons other than their underlying hematological/oncological disorder
• Patients who have received alemtuzumab or anti-thymocyte globulin (ATG) within 8 weeks of the transplant admission
• Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
• Patients with clinically significant preformed antibodies to their donors
• Patients who require supplemental oxygen other than for sleep apnea will be excluded