CompletedPhase 2

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

United States24 participantsStarted 2007-04

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response (Complete and Partial Response) in Patients With Myeloid Disorders

Timeframe: Up to 2 years

Trial details

NCT IDNCT00462605

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2017-03-06

View on ClinicalTrials.gov More Adult Acute Lymphoblastic Leukemia in Remission trials