Sirolimus and Azacitidine in Treating Patients With High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia That is Recurrent or Not Eligible for Intensive Chemotherapy

NCT01869114 | Completed Phase 2 Results DMC

• 3 other identifiers: 12D.5872012-50JT 3016
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 5

Brief Summary

This phase II trial studies how well sirolimus and azacitidine works in treating patients with high-risk myelodysplastic syndrome or recurrent acute myeloid leukemia. Sirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sirolimus and azacitidine may kill more cancer cells.

Conditions

Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Myelodysplastic Syndrome With Isolated Del(5q); Recurrent Adult Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); 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); de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response

  MDS: Patients meeting an erythroid response, a platelet response, or a neutrophil response will be considered responders. AML: Patients achieving a complete remission (CR), complete response in the absence of a total platelet recovery (CRp), or partial remission (PR) will be considered responders.

  Up to 5 years

Secondary Outcomes (3)

• Number of Participants With Adverse Events

  From the first dose of study drug through 30 days after the last dose of study treatment, an average of 7 months

• Mean Percentage of pS6-positive Blasts as Measured by Intracellular Flow Cytometry

  Up to day 4 before azacitidine administration

• Quality of Life (QOL) Assessed by the European Organization for Research and Treatment of Cancer (EORTC) QOL and the Mental Health Inventory (MHI)

  Up to day 164

Study Arms (3)

High risk Myleodysplastic Syndrome (MDS)

EXPERIMENTAL

Patients receive sirolimus PO on days 1-10 or 1-12 and azacitidine IV on days 4-8, 11, and 12 or days 4-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Sirolimus; Drug: Azacitidine

Acute Myeloid Leukemia (AML)

EXPERIMENTAL

Patients receive sirolimus PO on days 1-10 or 1-12 and azacitidine IV on days 4-8, 11, and 12 or days 4-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Sirolimus; Drug: Azacitidine

MDS or AML with prior Azacitadine therapy

EXPERIMENTAL

Patients receive sirolimus PO on days 1-10 or 1-12 and azacitidine IV on days 4-8, 11, and 12 or days 4-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Sirolimus; Drug: Azacitidine

Interventions

Sirolimus DRUG

Given PO

Also known as: rapamycin, Rapamune

Acute Myeloid Leukemia (AML); High risk Myleodysplastic Syndrome (MDS); MDS or AML with prior Azacitadine therapy

Azacitidine DRUG

Given IV

Also known as: 5-azacytidine, Vidaza

Acute Myeloid Leukemia (AML); High risk Myleodysplastic Syndrome (MDS); MDS or AML with prior Azacitadine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a diagnosis of one of the following:
• MDS (Arm A): High-risk MDS defined as: \>5% blasts in bone marrow and/or the following cytogenetic categories: presence of inv(3)/t(3q)/del(3q), -7/del(7q), complex cytogenetics (3 or more abnormalities)
• AML (Arm B): Relapsed/refractory/unable to tolerate conventional chemotherapy
• MDS or AML as above BUT with prior therapy with Azacitibine (Arm C): Patients who meet criteria for either Arm A or Arm B but have been treated or are currently treated with Azacitibine \*Note: As of July 2018, only high risk MDS patients will be eligible as Arm B is closed. As of October 2017, those patients with MDS who have received prior treatment will now be enrolled in Arm A as Arm C is closed.
• Patients must be ≥ 18 years old
• Patients must have an ECOG performance status of \<= 2 (see Attachment 1).
• Patients must have a life expectancy of at least 4 weeks.
• Patients must be able to consume oral medication.
• Patients must have completed any radiotherapy four weeks prior to study entry, 0-2 weeks for local palliative XRT (small port).
• Patients must have recovered from the toxic effects of any prior chemotherapy to \< Grade 2 (except for alopecia).
• Required initial laboratory values: Creatinine≤ 2.0mg/dL; total or direct bilirubin ≤ 1.5mg/dL (if not due to the leukemia itself or known Gilbert's Syndrome);(as documented by treating physician) SGPT(ALT) ≤ 3xULN; glucose \<200 mg/dL, negative pregnancy test for women of child-bearing potential.
• Patients must be able to sign consent and be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
• Patients may have had a prior stem cell transplant (autologous or allogeneic), however they may not have active GvHD, nor be on any immunosuppression

You may not qualify if:

• Patients must not be receiving any chemotherapy agents (except Hydroxyurea)
• Intrathecal ARA-C and intrathecal methotrexate are permissible (as they are not systemic and only isolated to the central nervous system).
• Patients can not have received more than 3 prior lines of therapy for their hematologic malignancy. Patient may have previously had azacitidine or decitabine will be eligible to enroll on Arm A (MDS)
• Patients must not be receiving growth factors.
• Patients with a current second malignancy requiring systemic therapy, other than non-melanoma skin cancers, are not eligible. If a patient has had a prior second malignancy that is not currently requiring active treatment, the patient will be considered eligible.
• Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, myocardial infarction within the past 6 months or serious uncontrolled cardiac arrhythmia are not eligible.
• Patients may not take any of the following medications while on study, but will be considered eligible if medication is discontinued 72 hrs prior to first dose of Sirolimus:
• Carbamazepine (e.g. Tegretol)
• Rifabutin (e.g. Mycobutin)
• Rifampin (e.g. Rifadin)
• Rifapentine (e.g. Priftin)
• St. John's Wort- may decrease effects of sirolimus by decreasing the amount of sirolimus in the body
• Clarithromycin (e.g. Biaxin)
• Cyclosporin e.g. (Neoral or Sandimmune)
• Diltiazem (e.g. Cardizem)

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University: lead

Study Sites (5)

Jefferson Health NJ Division (Kennedy Hospital)

Sewell, New Jersey, 08012, United States

Location

Abington Hospital - Jefferson Health

Abington, Pennsylvania, 19001, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Health, Aria Hospital

Philadelphia, Pennsylvania, 19124, United States

Location

Jefferson Health, Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

Related Publications (40)

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Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Congenital Abnormalities; Chromosome 5q Deletion Syndrome; Leukemia, Myeloid, Acute

Interventions

Sirolimus; Azacitidine

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Margaret T Kasner, MD
• Organization: Thomas Jefferson University

Margaret.Kasner@jefferson.edu

215-955-3202

Study Officials

• Margaret Kasner, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 5, 2013
• Study Start: July 8, 2013
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-11

Locations

US (5)