Who is sponsoring NCT01812252?

NCT01812252 is sponsored by Fred Hutchinson Cancer Center.

What drugs are being tested in NCT01812252?

Interventions in NCT01812252: Azacitidine (AZC), Decitabine, Quality-of-Life Assessment.

What condition does NCT01812252 study?

NCT01812252 studies Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Myelodysplastic Syndrome, Secondary Myelodysplastic Syndrome.

Is NCT01812252 still recruiting?

NCT01812252 is currently completed. Last updated 15 February 2024.

Are results published for NCT01812252?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-02-15 · How we verify

NCT01812252: ICT-HCT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant

Completed Phase 2 Results posted Last updated 15 February 2024

What this trial tests

Phase 2 trial testing Azacitidine (AZC) in Chronic Myelomonocytic Leukemia in 50 participants. Completed in 26 October 2022.

Timeline

19 August 2013

Primary endpoint
26 October 2022

26 October 2022

Quick facts

Lead sponsor	Fred Hutchinson Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	19 August 2013
Primary completion	26 October 2022
Estimated completion	26 October 2022
Sites	4 locations across United States

Drugs / interventions tested

Azacitidine (AZC) — full drug profile →
Decitabine (decitabine) — full drug profile →
Quality-of-Life Assessment

Conditions studied

Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →
de Novo Myelodysplastic Syndrome — all drugs for de Novo Myelodysplastic Syndrome →
Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →
Secondary Myelodysplastic Syndrome — all drugs for Secondary Myelodysplastic Syndrome →

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Chronic Myelomonocytic Leukemia or de Novo Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Failure-free Survival (Failure Defined as Death or Relapse) Primary · 18 months

18-month failure-free survival (failure defined as death or relapse).

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	6
Arm B (Induction-like Chemotherapy Regimen)	10

Quality of Life Will be Assessed Using the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire (EORTC QLQ-C30) Questionnaire. Secondary · EORTC QLQ-C30 questionnaire will be collected at screening, after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) just prior to stem cell infusion and 100 (± 14) days after stem cell infusion (HSCT).

The European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) (version 3) is a 30-item cancer-specific questionnaire for measuring the health-related quality of life (QOL) in cancer patients. It includes five functioning scales (physical, PF; role, RF; cognitive, CF; emotional, EF; and social, SF), three symptom scales (fatigue, FA; pain, PA; and nausea and vomiting, NV), a global health status/QOL scale (GL), and six single items (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial impact of the disease and treatment). All items em

EORTCQLQ-C30 at Screening 1. Do you have any trouble doing strenuous activities?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	2.27	1 – 4
Arm B (Induction Like Chemotherapy)	1.72	1 – 4

EORTCQLQ-C30 at Pre-Transplant 1. Do you have any trouble doing strenuous activities?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	2.14	1 – 4
Arm B (Induction Like Chemotherapy)	2.0	1 – 4

EORTCQLQ-C30 at post-transplant 1. Do you have any trouble doing strenuous activities?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	2.0	1 – 4
Arm B (Induction Like Chemotherapy)	1.81	1 – 4

EORTCQLQ-C30 at Screening 2. Do you have any trouble taking a long walk?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	2.40	1 – 4
Arm B (Induction Like Chemotherapy)	1.96	1 – 4

EORTCQLQ-C30 at Pre-transplant 2. Do you have any trouble taking a long walk?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	1.85	1 – 4
Arm B (Induction Like Chemotherapy)	1.83	1 – 4

EORTCQLQ-C30 at Post-transplant 2. Do you have any trouble taking a long walk?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	1.9	1 – 4
Arm B (Induction Like Chemotherapy)	1.63	1 – 4

EORTCQLQ-C30 at Screening 3. Do you have any trouble taking a short walk outside of the house?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	1.5	1 – 4
Arm B (Induction Like Chemotherapy)	1.24	1 – 4

EORTCQLQ-C30 at Pre-transplant 3. Do you have any trouble taking a short walk outside of the house?

Group	Value	95% CI
Arm A (Azacitidine or Decitabine)	1.42	1 – 4
Arm B (Induction Like Chemotherapy)	1.30	1 – 4

Quality of Life Will be Assessed Using the EORTC QLQ-HDC29 a Supplementary Module Assessing the Quality of Life During and After High-dose Chemotherapy and Stem Cell Transplantation. Secondary · EORTC QLQ-HDC29 questionnaire will be collected after completion of therapy (HMA 4-6 month, and up to 6 months for induction-like chemotherapy) pre stem cell infusion (HSCT), and 100 (± 14) days post stem cell infusion (HSCT).

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire High Dose Chemotherapy (EORTC QLQ-HDC29) is a treatment-specific quality of life questionnaire that addresses treatment specific side effects as well as emotional, social, and family issues for patients treated with high dose regimens and HCT. The QLQ-HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 single-items; all items employ a 4-point Likert scale, ranging from 1 (not at all) to 4 (very much) with lower scores representing a better outcome and higher scores a worse outcome with

QLQ-HDC 29 Pre-HSCT 31. Have you had soreness in your mouth?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.36	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.08	1 – 4

QLQ-HDC 29 Post-HSCT 31. Have you had soreness in your mouth?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.2	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.0	1 – 4

QLQ-HDC 29 Pre-HSCT 32. Have you had a dry mouth?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.36	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.62	1 – 4

QLQ-HDC 29 Post-HSCT 32. Have you had a dry mouth?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	2.0	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.7	1 – 4

QLQ-HDC 29 Pre-HSCT 33. Have you had trouble swallowing?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.07	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.15	1 – 4

QLQ-HDC 29 Post-HSCT 33. Have you had trouble swallowing?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.2	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.3	1 – 4

QLQ-HDC 29 Pre-HSCT 34. Did food and drink taste different from usual?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.57	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	1.92	1 – 4

QLQ-HDC 29 Post-HSCT 34. Did food and drink taste different from usual?

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	1.9	1 – 4
Arm B (Induction-like Chemotherapy Regimen)	2.2	1 – 4

Overall Survival Secondary · Up to 18 months

The total length of follow-up will be 18 months from the start of treatment (day 1). Four categories were added for participants alive 18 months from start of treatment (day 1) 1) Participants alive after 18 months from start of treatment who received hematopoietic cell transplantation (HCT); 2) Participants alive after 18months from start of treatment who did not receive HCT.; 3) Participants deceased after 18 months from start of treatment who received HCT; 4) Participants deceased after 18 months from start of treatment who did not receive HCT.

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	7
Arm B (Induction-like Chemotherapy Regimen)	10
Arm A (Decitabine or Azacitidine)	2
Arm B (Induction-like Chemotherapy Regimen)	1
Arm A (Decitabine or Azacitidine)	5
Arm B (Induction-like Chemotherapy Regimen)	3
Arm A (Decitabine or Azacitidine)	11
Arm B (Induction-like Chemotherapy Regimen)	11

Number of Patients Who Relapse Post-transplant Secondary · Up to 18 months

To compare which of the two, intensive chemotherapy versus hypomethylating agent-based therapy, have a factor of relapse post hematopoietic cell transplantation (HCT).

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	6
Arm B (Induction-like Chemotherapy Regimen)	3
Arm A (Decitabine or Azacitidine)	6
Arm B (Induction-like Chemotherapy Regimen)	10

Number of Participants Who Received a Hematopoietic Cell Transplantation (HCT). Secondary · Up to 18 months

Frequency at which the participants received a hematopoietic cell transplantation (HCT)

Group	Value	95% CI
Arm A (Decitabine or Azacitidine)	12
Arm B (Induction-like Chemotherapy Regimen)	13
Arm A (Decitabine or Azacitidine)	13
Arm B (Induction-like Chemotherapy Regimen)	12

Sponsor's own description

This randomized clinical trial studies different chemotherapies in treating patients with myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells, and may prevent the myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Allogeneic hematopoietic stem cell transplantation for MDS and CMML: recommendations from an international expert panel.
de Witte T, Bowen D, Robin M, Malcovati L, et al · · 2017 · cited 273× · PMID 28096091 · DOI 10.1182/blood-2016-06-724500
Trial Watch: Chemotherapy with immunogenic cell death inducers.
Vacchelli E, Aranda F, Eggermont A, Galon J, et al · · 2014 · cited 123× · PMID 24800173 · DOI 10.4161/onci.27878
Understanding the Continuum between High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia.
Zavras PD, Sinanidis I, Tsakiroglou P, Karantanos T. · · 2023 · cited 11× · PMID 36902450 · DOI 10.3390/ijms24055018
BMT for Myelodysplastic Syndrome: When and Where and How.
Jain AG, Elmariah H. · · 2021 · cited 11× · PMID 35070975 · DOI 10.3389/fonc.2021.771614
In MDS, is higher risk higher reward?
Sanz GF. · · 2019 · cited 7× · PMID 31808894 · DOI 10.1182/hematology.2019000042
Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?
Brunner AM, Fell G, Steensma DP. · · 2022 · cited 3× · PMID 35143613 · DOI 10.1182/bloodadvances.2021006357
Hypomethylating agents plus venetoclax for high-risk MDS and CMML as bridge therapy to transplant: a GESMD study.
Zugasti I, Lopez-Guerra M, Castaño-Díez S, Esteban D, et al · · 2025 · cited 2× · PMID 40287746 · DOI 10.1186/s40164-025-00652-5
Existing agents, novel agents, or transplantation for high-risk MDS.
Scott BL. · · 2020 · PMID 33275695 · DOI 10.1182/hematology.2020000125

Verify or expand the search:

Other recruiting trials for Chronic Myelomonocytic Leukemia

Currently open trials in the same condition.

NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting
NCT07046078 — Combination Chemotherapy (FLAG-Ida) Followed Immediately by Reduced-Intensity Total Body Radiation Therapy and Donor Hem · Phase 2 · recruiting
NCT06630221 — Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations · Phase 2 · recruiting
NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting

Other Fred Hutchinson Cancer Center trials

Trials by the same sponsor.

NCT07390968 — Self-Amplifying mRNA COVID-19 Vaccine (LUNAR-COV19) Versus Comirnaty Vaccine in Adult Hematopoietic Cell Transplant Pati · Phase 2 · not yet recruiting
NCT07493252 — A Behavioral Application for Improving Smoking Cessation Among Smokers · NA · not yet recruiting
NCT07490860 — A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to · NA · not yet recruiting
NCT07194980 — Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small L · Phase 2 · not yet recruiting
NCT07176000 — Tailored Patient Navigation to Improve the Uptake of Lung Cancer Screening in Tribal Communities in Western Washington S · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01812252 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fred Hutchinson Cancer Center
Last refreshed: 15 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01812252.

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