Protocol

RELHEM: A Pilot Pharmacokinetic, Pharmacodynamic, and Feasibility Study of Sorafenib in Combination with Cytarabine and Clofarabine in Patients with Refractory or Relapsed Hematologic Malignancies

Diseases

Leukemias / Lymphomas : Acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (both AML and ALL), AML w/prior myelodysplastic syndrome (MDS), myelodysplastic / myeloproliferative neoplasms, biphenotypic leukemia

Description

This is a preliminary study to describe the qualities of the toxicity profile of the drug sorafenib and to determine the maximum tolerated dose of sorafenib and clofarabine when given in combination with cytarabine and determine the feasibility of administering this drug combination. Participants in this study have relapsed (disease has returned) or refractory (disease is not responding to treatment) hematologic malignancies including acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (both AML and ALL), AML with prior myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, and biphenotypic leukemia.

Relapse is defined as the reappearance (in a patient who has previously achieved remission) of leukemic blasts in the peripheral blood or ≥5% blasts in the bone marrow, not attributable to any other cause (e.g., bone marrow regeneration).

Refractory disease is defined by the persistence of leukemic blasts after 1 or more courses of induction chemotherapy.


Objectives


Eligibility

Patients must have a diagnosis of acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (either AML or ALL), AML with prior myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, or biphenotypic leukemia. Patients with treatment-related AML (t-AML) will be eligible, provided they meet all other eligibility criteria. Current disease status must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life. Patients must meet one of the following criteria:

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).


Contact

Hiroto Inaba, MD, PhD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN  38105  USA
Voice:   1-866-2ST-JUDE  (1-866-278-5833)
FAX:     901-521-9005

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org


The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.