Phase 2
Completed N=24
MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
leukemia · Chronic myelomonocytic leukemia · de Novo Myelodysplastic Syndromes · Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Source: ClinicalTrials.gov NCT00462605 ↗
Enrolled (actual)
24
Serious AEs
79.2%
Results posted
Apr 2017
Primary outcomePrimary: Response (Complete and Partial Response) in Patients With Myeloid Disorders — 0; 1; 2; 5 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response (Complete and Partial Response) in Patients With Myeloid Disorders |
0; 1; 2; 5; 2 | — |
| SECONDARY Clinical Activity Assessed by Change in Peripheral Blood Counts |
578; 1137 | — |
| SECONDARY Clinical Activity Assessed by Change in Transfusion Requirements |
— | — |
| SECONDARY Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH) |
— | — |
| SECONDARY Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Newly diagnosed patients are eligible provided they do not qualify for potentially curative intensive chemotherapeutic regimens, including any of the following:
- Patients who have refused chemotherapy for untreated ALL
- Patients who are deemed to be poor candidates medically for ALL induction chemotherapy
- Relatively stable bone marrow function for > 7 days prior to study entry
- WBC count that has not doubled within the past 7 days
- WBC = 30,000/mm³)
- No active CNS disease
- Lumbar puncture with negative cytology required for patients with clinical symptoms of active CNS disease
- Not a candidate for a potentially curative allogeneic stem cell transplantation OR considered a poor candidate for such a procedure due to age, medical comorbidities, or lack of a suitable donor
- Hemoglobin >= 8 g/dL (transfusions allowed)
- Creatinine = 30,000/mm³
- ECOG performance status 0-2
Data sourced from ClinicalTrials.gov (NCT00462605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.