Recurrent Small Lymphocytic Lymphoma Clinical Trial
Official title:
A Phase II, Non-Randomized, Single Institution, Clinical Trial of Signal Transduction Inhibitors, Ibrutinib or Idelalisib, to Treat Patients With Persistent or Relapsed B-Cell Malignancies Following Allogeneic Hematopoietic Cell Transplantation
This phase II trial studies how well ibrutinib or idelalisib works in treating patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or non-Hodgkin lymphoma that is persistent or has returned (relapsed) after donor stem cell transplant. Ibrutinib and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To improve the outcomes of patients who have progressed or relapsed lymphoma or chronic
lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)/prolymphocytic leukemia (PLL)
within 180 days following allogeneic hematopoietic cell transplant (HCT) compared to
historical data: 12-month overall survival.
SECONDARY OBJECTIVES:
I. To describe the safety profile observed in these populations.
II. Estimate the overall response rate (complete response [CR] + partial response [PR]) by
standard morphologic, flow cytometric, imaging, and molecular techniques.
III. Assess progression free-survival.
IV. Define incidences of grade III-IV toxicities and infections.
V. Estimate incidence of relapse and non-relapse mortality.
VI. Estimate incidences of grade II-III and III-IV acute graft-versus-host disease (GVHD) and
chronic GVHD.
OUTLINE:
Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28 or idelalisib PO twice
daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
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