MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

This phase II trial is studying how well giving MS-275 together with GM-CSF works in treating patients with myelodysplastic syndrome and/or relapsed or refractory acute myeloid leukemia. MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving MS-275 together with GM-CSF may be an effective treatment for myelodysplastic syndrome and acute myeloid leukemia

Key facts

Study ID

NCT00462605

Run by

National Cancer Institute (NCI)

People needed

24

Starts

2007-04-01

Expected to finish

2011-03-01

Last updated by the study team

2017-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following diseases by bone marrow aspiration and/or biopsy:
• Myelodysplastic syndromes (MDS) meeting the following criteria:
• Must have 1 of the following subtypes:
• Refractory anemia (RA) (no RA with 5q-syndrome),
• RA with ringed sideroblasts or
• Refractory cytopenia with multilineage dysplasia
• Myelodysplastic syndromes (MDS) meeting the following criteria:
• Must have 1 of the following subtypes:
• Refractory cytopenia with multilineage dysplasia and ringed sideroblasts,
• RA with excess blasts (RAEB)-1, RAEB-2,
• Myelodysplastic syndromes, unclassified or
• Chronic myelomonocytic leukemia
• International Prognostic Scoring System score of intermediate-2 or high-risk
• Acute myeloid leukemia (AML) meeting 1 of the following criteria:
• Relapsed or refractory AML, including any of the following subtypes:
• * AML with recurrent cytogenetic abnormalities (i.e., AML with 11q23 [MLL] abnormalities)
• AML with multilineage dysplasia
• AML that is therapy-related
• AML, not otherwise categorized (M0 [minimally differentiated], M1 [without maturation], M2 [with maturation], M4 [myelomonocytic leukemia], M5 [monoblastic/monocytic leukemia], M6 [erythroid leukemia], and M7 [megakaryoblastic leukemia])
• Untreated AML
• Newly diagnosed patients are eligible provided they do not qualify for potentially curative intensive chemotherapeutic regimens
• Acute lymphocytic leukemia (ALL) meeting 1 of the following criteria:
• Relapsed or refractory ALL
• Patients with any measurable residual disease are eligible, including cytogenetic abnormalities
• Untreated ALL

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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