Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
With
Ohio State University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males or non-pregnant, non-lactating females, ≥ 18 years of age
Able to understand and willing to sign informed consent.
Histologically confirmed hematologic malignancy that is deemed best treated by RIC allogeneic SCT, including:
Acute myeloid or lymphoblastic leukemia (AML, ALL) with \< 5% blasts in the bone marrow
Myelodysplastic syndrome and intermediate-2 or high-risk IPSS score with \< 5% blasts in the bone marrow
Chronic myelogenous leukemia failing to respond to at least two different tyrosine kinase inhibitors
Multiple myeloma that has relapsed following autologous stem cell transplant
Follicular lymphoma (grades 1, 2, or 3a by WHO criteria) or monocytoid lymphoma that has relapsed following at least two prior chemotherapy regimens and with either no lymph node groups ≥ 3 cm or with a ≥ 50% reduction in estimated lymph node diameter with most recent salvage therapy
Diffuse large B-cell NHL that has relapsed after at least 2 prior chemotherapy regimens (could include high-dose chemotherapy with autologous stem cell rescue) and is still sensitive to chemotherapy by virtue of a PR or CR following most recent salvage chemotherapy
Transformed follicular lymphoma that has achieved a PR or CR following chemotherapy
Mantle cell lymphoma that has relapsed after at least 2 prior chemotherapy regimens (could include high-dose chemotherapy with autologous stem cell rescue)
CLL/SLL/PLL that meets one of the following:
del (17p13.1) in first remission
Response no better than a PR with chemoimmunotherapy or relapse within 2 years of chemoimmunotherapy
Richter's transformation
Complex karyotype
At least 4 weeks beyond prior chemotherapy (excluding steroids), antibody therapy, radiation, or radioimmunoconjugate therapy, and with any kinase inhibitors discontinued at least one week prior to starting the conditioning regimen.
ECOG performance status ≤ 2
Life expectancy of greater than 3 months
Adequate organ function measured by the following within seven days of beginning conditioning:
AST (SGOT) ≤ 3.0 x institutional upper limit of normal (IULN)
Total bilirubin ≤ 1.5 xIULN unless due to Gilbert's disease
Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
DLCO \> 40% with no symptomatic pulmonary disease
LVEF by echocardiogram or MUGA of at least 30%
Women of child bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
Matched (8/8) related or matched unrelated donor identified. Haploidentical or umbilical cord grafts are not allowed.
Donor willing to donate peripheral blood stem cells and meets institutional criteria for stem cell donation.
You may not be if
Prior allogeneic stem cell transplant
Patients requiring a myeloablative conditioning regimen
No suitable donor identified
Prior anaphylactic response or Grade 4 infusion reaction to milatuzumab
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
LVEF \< 30%
Seropositivity for HIV or Hepatitis C
Patients with known CNS lymphoma are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Active secondary malignancies with the exception of non-melanomatous skin cancers or low risk prostate cancer under observation.
