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Compares treatment options for Chronic Myelomonocytic Leukemia
Official title IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
ClinicalTrials.gov ID: NCT06647862
What this study is testing
What is IMM01?
IMM01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic myelomonocytic leukemia.
Also referred to as Timdarpacept.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a randomized, controlled, double-blind, multicenter, phase Ⅲ clinical study to evaluate the efficacy of IMM01(timdarpacept) in combination with azacitidine versus placebo in combination with azacitidine in patients with newly diagnosed chronic leukemia monocytic (CMML1-2).Primary endpoint are Complete remission rate and Overall survival.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old, regardless of gender;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Life expectancy ≥ 12 weeks;
- Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
- White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed).
You likely can't join if
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
- History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
- Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic...
- Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph...
- Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or...
See the full eligibility criteria
- Age ≥ 18 years old, regardless of gender;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Life expectancy ≥ 12 weeks;
- Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
- White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed).
- Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy\<1 cycle, and the washout period should be more than 28 days, which is acceptable.), allogeneic stem cell...
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein;
- History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
- Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN...
- Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma;
- Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer,Surgery-cured prostate cancer and papillary thyroid...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Lanzhou, Gansu, China
- Nanning, Gaungxi, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhujiang, Guangdong, China
- Guangzhou, Guangzhou, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Xiangyang, Hubei, China
- Changsha, Hunan, China
- Changzhou, Jiangsu, China
- Nanjing, Jiangsu, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Lanzhou, Gansu, China; Nanning, Gaungxi, China; Guangzhou, Guangdong, China and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.