Clinical trial · Interventional
MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
A Phase II Study of and Oral Histone Deacytylase Inhibitor, MS-275 (NSC 706995), in Combination With Sargramostim (GM-CSF, Berlex, Inc.) Treating Relapsed and Refractory Myeloid Malignancies
NCT00462605CI-TRIAL-00028671completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (28)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
| sargramostim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral MS-275 on days 1, 8, 15, and 22. Patients also receive sargramostim (GM-CSF) subcutaneously once daily on days 1-42 in courses 3 and 5 and on days 1-35 in courses 1, 2, 4, and 6. Treatment repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable toxicity. After completion of 2 courses of study therapy, patients who achieve a complete or partial response may receive an additional 4 courses. Patients who maintain stable disease for more than 2 months after completion of 6 courses of study therapy may receive an additional 6 courses at the time of disease progression, provided they meet original eligibility criteria.
- interventionNames
- Drug: entinostat
- Drug: sargramostim
Primary outcomes (1)
- measure
- Response (Complete and Partial Response) in Patients With Myeloid Disorders
- timeFrame
- Up to 2 years
- description
- Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 =\<10,000/mm³ * No uncontrolled peripheral leukemia (i.e., blast count \> 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 =\< 2.0 mg/dL * Bilirubin =\< 1.6 mg/dL (unless secondary to hemolysis) * AST or ALT =\< 3 times upper limit of normal (unless disease-related) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No untreated or progressive infections * No history of intolerance to sargramostim (GM-CSF) * Recovered from all treatment-related toxicities * More than 2 weeks since prior therapy for AML, ALL, or MDS, including chemotherapy, hematopoietic growth factors, or biologic therapy such as monoclonal antibodies * Concurrent hydroxyurea allowed during course 1 for control of leukocytosis if WBC \> 30,000/mm³ * ECOG performance status 0-2
References
Publications (0)
Data not yet available
No reference posted for this study.