MyelofibrosisPhase 1ATIOMNCT05535764
AlloHCT With PegINFa for Myelofibrosis
A Phase 1 study testing Pegylated interferon alpha2a in people with Myelofibrosis, run by University of Utah at 1 site in United States.
Trial summary
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- Pegylated interferon alpha2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Transplant Inclusion Criteria (Step 1)
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary or secondary myelofibrosis.
- Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC)
- Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up.
- Peripheral blood stem cell (PBSC) graft
Show all 47Show fewer
- 10/10 HLA matched related or matched unrelated donor
- ECOG performance status ≤ 2.
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
- Treatment Inclusion Criteria (Step 2)
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary or secondary myelofibrosis.
- Have undergone a myeloablative or reduced-intensity conditioning regimen (MAC or RIC) and be 50-80 days from Day 0 of transplant at initiation of study therapy.
- Peripheral blood stem cell (PBSC) graft
- 10/10 HLA matched related or matched unrelated donor
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined as:
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- Renal:
- ---Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- TSH and T4 within normal limits or adequately controlled thyroid function.
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.
- Male subjects must agree to use a condom during intercourse for the duration of study therapy as described in Section 5.4.1.
- Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Receiving other investigational agents concurrently
- Prior systemic anti-cancer therapy or any investigational therapy within five half-lives prior to starting study treatment.
- Prior radiotherapy within 6 weeks prior to the first dose of study treatment.
- Major surgery within 6 weeks prior to starting study drug or patients who have not fully recovered from major surgery.
- The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Show all 24Show fewer
- Graft-versus-host disease:
- ---Acute or chronic
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
- QTc prolongation defined as a QTcF > 500 ms.
- Known congenital long QT.
- Left ventricular ejection fraction < 55%.
- Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [subjects may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Active infection including HIV, tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice) or hepatitis C.
- --Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
- Autoimmune hepatitis or decompensated hepatic disease
- Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 6.5.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
- History of neuropsychiatric disease, autoimmune disease, or pancreatitis.
- Presence of active interstitial lung disease or pneumonitis, bronchiolitis obliterans, pulmonary hypertension, ulcerative and hemorrhagic/ischemic colitis, and ophthalmologic disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, Rachel.Kingsford@hci.utah.edu
Sagar Patel, MD
About this study
Official title: Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis (ATIOM)
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.
- Conditions
- Myelofibrosis
- Being tested
- Pegylated interferon alpha2a
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated interferon alpha2aDrug
PegINFa will be given once every 2 weeks by subcutaneous administration in the abdomen or thigh.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: All Patients | Experimental | A 3+3 dose de-escalation design will be used to determine the recommended phase 2 dose,while ensuring the safety and tolerability of the treatment. In this trial, the dose determined to be the maximum tolerated dose will be the recommended phase 2 dose and will be utilized in the cohort expansion. Receives: Drug: Pegylated interferon alpha2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
To identify the Recommended Phase 2 Dose (RP2D) of pegylated interferon alfa-2a in subjects undergoing allogeneic hematopoietic cell transplantation for primary or secondary myelofibrosis
Measured: Start of treatment to 86 days after treatment initiation
Secondary outcomes (6)
Assess the safety of pegylated interferon alfa-2a in the study population.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0), seriousness, duration, and relationship to study treatment.
Measured: 3 years
Assess the tolerability of pegylated interferon alfa-2a in the study population.
Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE version 5.0), seriousness, duration, and relationship to study treatment.
Measured: 3 years
Assess the rate of treatment-related mortality in the study population.
Rate of treatment-related mortality which is defined as proportion of deaths in patients who have received at least one dose of study therapy, which is attributed to complications from alloHCT or conditioning therapy (in the absence of myelofibrosis relapse) from 30 days after the end of conditioning therapy to one week after the last dose of study therapy.
Measured: 3 years
Assess Objective Response Rate (ORR) in the study population.
Response rates according to IWG-MRT including, CR, PR, CI, PD, SD, or Relapse.
Measured: 3 Years
Assess leukemia-free survival (LFS) in the study population.
Rate of Leukemia-free survival (LFS) as defined from the day of allogeneic hematopoietic cell transplantation to the time documented disease relapse/progression (date of bone marrow blast count of 20% or greater or date of first peripheral blast count of 20% or greater that was subsequently confirmed to sustain for at least 8 weeks), initiation of non-protocol MF therapy, loss to follow-up, study end, or death from any cause, whichever comes first.
Measured: 3 years
Assess the incidence of acute and/or chronic graft versus host disease (GVHD) in the study population
Cumulative incidence of Glucksberg grade II, III, and IV acute GVHD and incidence of mild, moderate or severe chronic GVHD per NIH grading criteria.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start2 Aug 2023
- Primary completionJan 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Sagar Patel, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535764
- Sponsor's protocol ID
- 149616
- Acronym
- ATIOM
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mesa RA, Silverstein MN, Jacobsen SJ, Wollan PC, Tefferi A. Population-based incidence and survival figures in essential thrombocythemia and agnogenic myeloid metaplasia: an Olmsted County Study, 1976-1995. Am J Hematol. 1999 May;61(1):10-5. doi: 10.1002/(sici)1096-8652(199905)61:13.0.co;2-i.
PubMed 10331505Tefferi A. Primary myelofibrosis: 2019 update on diagnosis, risk-stratification and management. Am J Hematol. 2018 Dec;93(12):1551-1560. doi: 10.1002/ajh.25230. Epub 2018 Oct 26.
PubMed 30039550Ballen KK, Shrestha S, Sobocinski KA, Zhang MJ, Bashey A, Bolwell BJ, Cervantes F, Devine SM, Gale RP, Gupta V, Hahn TE, Hogan WJ, Kroger N, Litzow MR, Marks DI, Maziarz RT, McCarthy PL, Schiller G, Schouten HC, Roy V, Wiernik PH, Horowitz MM, Giralt SA, Arora M. Outcome of transplantation for myelofibrosis. Biol Blood Marrow Transplant. 2010 Mar;16(3):358-67. doi: 10.1016/j.bbmt.2009.10.025. Epub 2009 Oct 30.
PubMed 19879949Patriarca F, Bacigalupo A, Sperotto A, Isola M, Soldano F, Bruno B, van Lint MT, Iori AP, Santarone S, Porretto F, Pioltelli P, Visani G, Iacopino P, Fanin R, Bosi A; GITMO. Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Haematologica. 2008 Oct;93(10):1514-22. doi: 10.3324/haematol.12828. Epub 2008 Aug 25.
PubMed 18728030Gupta V, Malone AK, Hari PN, Ahn KW, Hu ZH, Gale RP, Ballen KK, Hamadani M, Olavarria E, Gerds AT, Waller EK, Costa LJ, Antin JH, Kamble RT, van Besien KM, Savani BN, Schouten HC, Szer J, Cahn JY, de Lima MJ, Wirk B, Aljurf MD, Popat U, Bejanyan N, Litzow MR, Norkin M, Lewis ID, Hale GA, Woolfrey AE, Miller AM, Ustun C, Jagasia MH, Lill M, Maziarz RT, Cortes J, Kalaycio ME, Saber W. Reduced-intensity hematopoietic cell transplantation for patients with primary myelofibrosis: a cohort analysis from the center for international blood and marrow transplant research. Biol Blood Marrow Transplant. 2014 Jan;20(1):89-97. doi: 10.1016/j.bbmt.2013.10.018. Epub 2013 Oct 23.
PubMed 24161923Slot S, Smits K, van de Donk NW, Witte BI, Raymakers R, Janssen JJ, Broers AE, Te Boekhorst PA, Zweegman S. Effect of conditioning regimens on graft failure in myelofibrosis: a retrospective analysis. Bone Marrow Transplant. 2015 Nov;50(11):1424-31. doi: 10.1038/bmt.2015.172. Epub 2015 Aug 3.
PubMed 26237165Chhabra S, Narra RK, Wu R, Szabo A, George G, Michaelis LC, D'Souza A, Dhakal B, Drobyski WR, Fenske TS, Jerkins JH, Pasquini MC, Rizzo RD, Saber W, Shah NN, Shaw BE, Hamadani M, Hari PN. Fludarabine/Busulfan Conditioning-Based Allogeneic Hematopoietic Cell Transplantation for Myelofibrosis: Role of Ruxolitinib in Improving Survival Outcomes. Biol Blood Marrow Transplant. 2020 May;26(5):893-901. doi: 10.1016/j.bbmt.2020.01.010. Epub 2020 Jan 23.
PubMed 31982543Guardiola P, Anderson JE, Bandini G, Cervantes F, Runde V, Arcese W, Bacigalupo A, Przepiorka D, O'Donnell MR, Polchi P, Buzyn A, Sutton L, Cazals-Hatem D, Sale G, de Witte T, Deeg HJ, Gluckman E. Allogeneic stem cell transplantation for agnogenic myeloid metaplasia: a European Group for Blood and Marrow Transplantation, Societe Francaise de Greffe de Moelle, Gruppo Italiano per il Trapianto del Midollo Osseo, and Fred Hutchinson Cancer Research Center Collaborative Study. Blood. 1999 May 1;93(9):2831-8.
PubMed 10216077Jacobson RJ, Salo A, Fialkow PJ. Agnogenic myeloid metaplasia: a clonal proliferation of hematopoietic stem cells with secondary myelofibrosis. Blood. 1978 Feb;51(2):189-94.
PubMed 620081Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.
PubMed 29217781Wang X, Ye F, Tripodi J, Hu CS, Qiu J, Najfeld V, Novak J, Li Y, Rampal R, Hoffman R. JAK2 inhibitors do not affect stem cells present in the spleens of patients with myelofibrosis. Blood. 2014 Nov 6;124(19):2987-95. doi: 10.1182/blood-2014-02-558015. Epub 2014 Sep 5.
PubMed 25193869Pizzi M, Silver RT, Barel A, Orazi A. Recombinant interferon-alpha in myelofibrosis reduces bone marrow fibrosis, improves its morphology and is associated with clinical response. Mod Pathol. 2015 Oct;28(10):1315-23. doi: 10.1038/modpathol.2015.93. Epub 2015 Aug 14.
PubMed 26271725Liu E, Jelinek J, Pastore YD, Guan Y, Prchal JF, Prchal JT. Discrimination of polycythemias and thrombocytoses by novel, simple, accurate clonality assays and comparison with PRV-1 expression and BFU-E response to erythropoietin. Blood. 2003 Apr 15;101(8):3294-301. doi: 10.1182/blood-2002-07-2287. Epub 2002 Dec 19.
PubMed 12515724King KY, Matatall KA, Shen CC, Goodell MA, Swierczek SI, Prchal JT. Comparative long-term effects of interferon alpha and hydroxyurea on human hematopoietic progenitor cells. Exp Hematol. 2015 Oct;43(10):912-918.e2. doi: 10.1016/j.exphem.2015.05.013. Epub 2015 Jun 11.
PubMed 26072330Xiong Z, Liu E, Yan Y, Silver RT, Yang F, Chen IH, Chen Y, Verstovsek S, Wang H, Prchal J, Yang XF. An unconventional antigen translated by a novel internal ribosome entry site elicits antitumor humoral immune reactions. J Immunol. 2006 Oct 1;177(7):4907-16. doi: 10.4049/jimmunol.177.7.4907.
PubMed 16982933
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis (ATIOM)
- ClinicalTrials.gov ID
- NCT05535764
- Acronym / sponsor ID
- ATIOM / 149616
- Conditions
- Myelofibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Huntsman Cancer Institute
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: All Patients | Experimental | Drug: Pegylated interferon alpha2aA 3+3 dose de-escalation design will be used to determine the recommended phase 2 dose,while ensuring the safety and tolerability of the treatment. In this trial, the dose determined to be the maximum tolerated dose will be the recommended phase 2 dose and will be utilized in the cohort expansion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (47 listed)
- Pre-Transplant Inclusion Criteria (Step 1)
- Male or female subject aged ≥ 18 years.
- Diagnosis of primary or secondary myelofibrosis.
- Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC)
- Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up.
Key exclusion criteria (24 listed)
- Receiving other investigational agents concurrently
- Prior systemic anti-cancer therapy or any investigational therapy within five half-lives prior to starting study treatment.
- Prior radiotherapy within 6 weeks prior to the first dose of study treatment.
- Major surgery within 6 weeks prior to starting study drug or patients who have not fully recovered from major surgery.
- The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated interferon alpha2aPegINFa will be given once every 2 weeks by subcutaneous administration in the abdomen or thigh. | Drug | Treatment: All Patients |
Primary outcome
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period
Time frame: Start of treatment to 86 days after treatment initiation
To identify the Recommended Phase 2 Dose (RP2D) of pegylated interferon alfa-2a in subjects undergoing allogeneic hematopoietic cell transplantation for primary or secondary myelofibrosis
6 secondary outcomes
Assess the safety of pegylated interferon alfa-2a in the study population.
Time frame: 3 years
Assess the tolerability of pegylated interferon alfa-2a in the study population.
Time frame: 3 years
Assess the rate of treatment-related mortality in the study population.
Time frame: 3 years
Assess Objective Response Rate (ORR) in the study population.
Time frame: 3 Years
Assess leukemia-free survival (LFS) in the study population.
Time frame: 3 years
Assess the incidence of acute and/or chronic graft versus host disease (GVHD) in the study population
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 10331505Mesa RA, Silverstein MN, Jacobsen SJ, Wollan PC, Tefferi A. Population-based incidence and survival figures in essential thrombocythemia and agnogenic myeloid metaplasia: an Olmsted County Study, 1976-1995. Am J Hematol. 1999 May;61(1):10-5. doi: 10.1002/(sici)1096-8652(199905)61:13.0.co;2-i.
- Background: PubMed 30039550Tefferi A. Primary myelofibrosis: 2019 update on diagnosis, risk-stratification and management. Am J Hematol. 2018 Dec;93(12):1551-1560. doi: 10.1002/ajh.25230. Epub 2018 Oct 26.
- Background: PubMed 19879949Ballen KK, Shrestha S, Sobocinski KA, Zhang MJ, Bashey A, Bolwell BJ, Cervantes F, Devine SM, Gale RP, Gupta V, Hahn TE, Hogan WJ, Kroger N, Litzow MR, Marks DI, Maziarz RT, McCarthy PL, Schiller G, Schouten HC, Roy V, Wiernik PH, Horowitz MM, Giralt SA, Arora M. Outcome of transplantation for myelofibrosis. Biol Blood Marrow Transplant. 2010 Mar;16(3):358-67. doi: 10.1016/j.bbmt.2009.10.025. Epub 2009 Oct 30.
- Background: PubMed 18728030Patriarca F, Bacigalupo A, Sperotto A, Isola M, Soldano F, Bruno B, van Lint MT, Iori AP, Santarone S, Porretto F, Pioltelli P, Visani G, Iacopino P, Fanin R, Bosi A; GITMO. Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Haematologica. 2008 Oct;93(10):1514-22. doi: 10.3324/haematol.12828. Epub 2008 Aug 25.
- Background: PubMed 24161923Gupta V, Malone AK, Hari PN, Ahn KW, Hu ZH, Gale RP, Ballen KK, Hamadani M, Olavarria E, Gerds AT, Waller EK, Costa LJ, Antin JH, Kamble RT, van Besien KM, Savani BN, Schouten HC, Szer J, Cahn JY, de Lima MJ, Wirk B, Aljurf MD, Popat U, Bejanyan N, Litzow MR, Norkin M, Lewis ID, Hale GA, Woolfrey AE, Miller AM, Ustun C, Jagasia MH, Lill M, Maziarz RT, Cortes J, Kalaycio ME, Saber W. Reduced-intensity hematopoietic cell transplantation for patients with primary myelofibrosis: a cohort analysis from the center for international blood and marrow transplant research. Biol Blood Marrow Transplant. 2014 Jan;20(1):89-97. doi: 10.1016/j.bbmt.2013.10.018. Epub 2013 Oct 23.
- Background: PubMed 26237165Slot S, Smits K, van de Donk NW, Witte BI, Raymakers R, Janssen JJ, Broers AE, Te Boekhorst PA, Zweegman S. Effect of conditioning regimens on graft failure in myelofibrosis: a retrospective analysis. Bone Marrow Transplant. 2015 Nov;50(11):1424-31. doi: 10.1038/bmt.2015.172. Epub 2015 Aug 3.
- Background: PubMed 31982543Chhabra S, Narra RK, Wu R, Szabo A, George G, Michaelis LC, D'Souza A, Dhakal B, Drobyski WR, Fenske TS, Jerkins JH, Pasquini MC, Rizzo RD, Saber W, Shah NN, Shaw BE, Hamadani M, Hari PN. Fludarabine/Busulfan Conditioning-Based Allogeneic Hematopoietic Cell Transplantation for Myelofibrosis: Role of Ruxolitinib in Improving Survival Outcomes. Biol Blood Marrow Transplant. 2020 May;26(5):893-901. doi: 10.1016/j.bbmt.2020.01.010. Epub 2020 Jan 23.
- Background: PubMed 10216077Guardiola P, Anderson JE, Bandini G, Cervantes F, Runde V, Arcese W, Bacigalupo A, Przepiorka D, O'Donnell MR, Polchi P, Buzyn A, Sutton L, Cazals-Hatem D, Sale G, de Witte T, Deeg HJ, Gluckman E. Allogeneic stem cell transplantation for agnogenic myeloid metaplasia: a European Group for Blood and Marrow Transplantation, Societe Francaise de Greffe de Moelle, Gruppo Italiano per il Trapianto del Midollo Osseo, and Fred Hutchinson Cancer Research Center Collaborative Study. Blood. 1999 May 1;93(9):2831-8.
- Background: PubMed 620081Jacobson RJ, Salo A, Fialkow PJ. Agnogenic myeloid metaplasia: a clonal proliferation of hematopoietic stem cells with secondary myelofibrosis. Blood. 1978 Feb;51(2):189-94.
- Background: PubMed 29217781Ianotto JC, Chauveau A, Boyer-Perrard F, Gyan E, Laribi K, Cony-Makhoul P, Demory JL, de Renzis B, Dosquet C, Rey J, Roy L, Dupriez B, Knoops L, Legros L, Malou M, Hutin P, Ranta D, Benbrahim O, Ugo V, Lippert E, Kiladjian JJ. Benefits and pitfalls of pegylated interferon-alpha2a therapy in patients with myeloproliferative neoplasm-associated myelofibrosis: a French Intergroup of Myeloproliferative neoplasms (FIM) study. Haematologica. 2018 Mar;103(3):438-446. doi: 10.3324/haematol.2017.181297. Epub 2017 Dec 7.
- Background: PubMed 25193869Wang X, Ye F, Tripodi J, Hu CS, Qiu J, Najfeld V, Novak J, Li Y, Rampal R, Hoffman R. JAK2 inhibitors do not affect stem cells present in the spleens of patients with myelofibrosis. Blood. 2014 Nov 6;124(19):2987-95. doi: 10.1182/blood-2014-02-558015. Epub 2014 Sep 5.
- Background: PubMed 26271725Pizzi M, Silver RT, Barel A, Orazi A. Recombinant interferon-alpha in myelofibrosis reduces bone marrow fibrosis, improves its morphology and is associated with clinical response. Mod Pathol. 2015 Oct;28(10):1315-23. doi: 10.1038/modpathol.2015.93. Epub 2015 Aug 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sagar Patel, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pegylated interferon alpha2a in people with Myelofibrosis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kingsford (801-585-0115, Rachel.Kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period (time frame: Start of treatment to 86 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05535764, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.