Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT02303821) enrolled 141 participants across eight groups. The trial was testing carfilzomib — a medicine given at different doses — in combination with other treatments for acute lymphoblastic leukaemia (a type of blood cancer). The study had two parts: a Phase 1b section (35 participants across six smaller groups) that tested different dose levels to examine how the drug behaved in the body, and a Phase 2 section (106 participants split into a B-cell group of 62 and a T-cell group of 44) that looked at response rates and side effects at the highest dose tested. The reported data shows that in the Phase 1b dose-finding part, the peak level of carfilzomib measured in participants' blood (the highest concentration recorded after a dose) ranged from around 445 ng/mL in one lower-dose group up to 11,200 ng/mL in the highest-dose group. The proportion of Phase 1b participants whose leukaemia showed no detectable cancer cells in the bone marrow by the end of the initial treatment cycle ranged from 20% to 40% depending on the dose group. The proportion who reached very low levels of remaining cancer cells (a measure called minimal residual disease) was reported as 0% in most groups, with 14.3% and 25% recorded in two of the mid-range dose groups. The reported data shows that in the Phase 2 part, all 61 B-cell participants and all 44 T-cell participants who received the study drug experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred during or after treatment). Of those, 50 B-cell and 39 T-cell participants experienced events considered related to the study drugs, and 15 B-cell and 3 T-cell participants experienced serious adverse events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 1 Lymphoma Trial, Completed
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 21 years old or younger when you were first diagnosed with ALL (acute lymphoblastic leukemia), and at least 1 year old (or at least 1 month old for Phase 2) when starting treatment in the study
- You have been diagnosed with ALL that has come back or has not responded to treatment, with a significant number of leukemia cells still found in your bone marrow
- Your leukemia previously went into remission at least once, but has since returned or stopped responding to treatment
- For B-cell ALL (Phase 2): your leukemia came back after you received a specific type of targeted treatment such as blinatumomab, inotuzumab, or CAR-T therapy
- Your body has fully recovered from the side effects of any previous cancer treatments before joining the study
- Your kidneys are working well enough, based on blood tests showing normal or near-normal kidney function
- Your liver is working well enough, based on blood tests showing normal or near-normal liver function
- Your heart is working well enough, with the heart pumping or squeezing normally (confirm with trial site)
- You are able to carry out some daily activities on your own, based on a standard health scale used by doctors
- Doctors expect you to live for more than 6 weeks at the time of screening (Phase 2)
- A parent or legal guardian has given written permission for you to take part if you are too young to consent yourself, and you have also given your written agreement where required
Who may not be able to join:
- You have a known allergy to any of the drugs used in the study, including the main study drug (carfilzomib) or a substance called Captisol used to prepare it
- You have a history of moderate or severe inflammation of the pancreas (pancreatitis)
- You have previously been treated with the study drug carfilzomib (Phase 2)
- You have had a stem cell transplant using your own cells within the past 6 weeks, or a transplant using someone else's cells within the past 3 months
- You are currently experiencing graft-versus-host disease (a complication after a donor stem cell transplant) that needs medication to treat it
- You stopped taking medications to suppress your immune system after a transplant complication less than 30 days ago
- You have a current bacterial or fungal infection within the past 14 days before joining the study
- You have an active viral infection such as HIV, active Hepatitis B, active Hepatitis C, or active CMV (cytomegalovirus)
- You have Down Syndrome
- You have another active cancer at the same time
- You have heart rhythm problems or an abnormal heart electrical reading on a specific test (ECG) (confirm with trial site)
- You are pregnant, breastfeeding, or planning to become pregnant during the study or for several months after finishing treatment
- You are a woman who could become pregnant and are not willing to use a reliable form of birth control during and after treatment
- You are a man with a partner who could become pregnant and are not willing to use a condom during and after treatment
- You are a man who is unwilling to avoid donating sperm during and for 6 months after treatment
- You are currently taking part in another clinical trial, or finished one less than 14 days ago
- You received certain cancer treatments too recently before the study start date (different waiting times apply depending on the type of treatment — confirm with trial site)
- You have unresolved side effects from previous cancer treatment that have not settled down enough (confirm with trial site)
- You only have leukemia outside the bone marrow with no bone marrow involvement (Phase 2)
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1b: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs); Phase 1b: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs); Phase 2: Percentage of Participants With Complete Remission (CR) After Induction Therapy
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.