Phase 2 Lymphoma Trial, Recruiting NCT06985485 Sponsor: The First Affiliated Hospital of Soochow University Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT06985485
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 60 years of age or older and have been newly diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL)
  • You are between 15 and 59 years old, newly diagnosed with B-ALL, and your doctor has determined you are not healthy enough for intensive chemotherapy due to at least one of the following: low physical functioning, serious heart problems, serious lung problems, serious kidney problems, serious liver problems, an infection that is not responding to treatment, documented memory or thinking problems, or other health conditions that make intensive chemotherapy too risky
  • You are between 15 and 59 years old, newly diagnosed with B-ALL, are physically well enough for intensive chemotherapy, but have personally chosen not to pursue it (for example, due to concerns about side effects, financial or personal reasons, or quality of life preferences)
  • You are 15 years of age or older and your B-ALL has come back or stopped responding to previous chemotherapy, or tests show remaining signs of cancer (called MRD positivity) after prior treatment
  • Your heart is pumping at least 40% of its normal capacity, as confirmed by an ultrasound of the heart
  • Your kidneys are filtering blood at a sufficient level (creatinine clearance of at least 30 mL/min)
  • Your liver function results are within an acceptable range (unless abnormalities are caused by the leukemia itself)
  • You are able to breathe without significant difficulty and maintain adequate oxygen levels without needing extra oxygen
  • You are able to understand and willingly sign a consent form agreeing to take part
  • Your doctor expects you to live for at least 3 more months

Who may not be able to join:

  • The leukemia has spread to your brain, spinal cord, or other areas outside the bone marrow
  • You currently have another active cancer or one that requires treatment
  • You have previously been treated with therapies that target proteins called CD19 or CD22, including certain immunotherapy drugs or CAR-T cell therapies
  • You have taken immune-suppressing medications within the 2 weeks before signing the consent form, or you plan to take them long-term during the study
  • You have significant heart disease that causes symptoms during minimal activity or at rest (confirm with trial site)
  • You have severe chronic liver disease, such as cirrhosis or active hepatitis B or C (though people with certain past hepatitis B or C infections may still be eligible under specific conditions — confirm with trial site)
  • You have a history of a serious liver condition involving blocked blood vessels in the liver (VOD/SOS)
  • You currently have an uncontrolled bacterial, fungal, viral, or other infection, or you have HIV, syphilis, or an active COVID-19 infection
  • You have a history of or currently have a neurological condition such as seizures, stroke, dementia, or certain autoimmune diseases affecting the brain or nervous system
  • You have a primary immune system disorder or an active autoimmune disease
  • You have had a severe allergic reaction to any of the medications used in this study
  • You received a live vaccine within 6 weeks before screening
  • You have a psychiatric condition or other issue that may make it difficult to follow the study requirements
  • You are pregnant, breastfeeding, or are able to have children but are unwilling to use contraception during the study
  • Your doctor has determined for any other reason that this study is not appropriate for you

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Sheng-Li Xue, M.D., The First Affiliated Hospital of Soochow University

Phone: 008651267781139

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
The First Affiliated Hospital of Soochow University
Registry
ClinicalTrials.gov
Start date
17 May 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall Survival(OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov