A Phase 2 interventional study of Bortezomib in Acute Lymphoblastic Leukemia, in Relapse and Acute Lymphoblastic Leukemia With Failed Remission, sponsored by Instituto do Cancer do Estado de São Paulo. Recruiting at 1 site in Brazil. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Instituto do Cancer do Estado de São Paulo · Phase 2, Interventional, and Treatment
Among 36 studies testing bortezomib in Precursor Cell Lymphoblastic Leukemia-Lymphoma — 6 open to participants now, 8 under way, 3 of them phase 3. Bortezomib · Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Among the 36 studies testing bortezomib in Precursor Cell Lymphoblastic Leukemia-Lymphoma, this one is the 14th largest by planned enrollment of the 33 interventional ones that give a count, is the only one that started in 2024, is one of 13 in phase 2, and was the 36th registered.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →6 of the 36 studies testing bortezomib in Precursor Cell Lymphoblastic Leukemia-Lymphoma are open now, in 12 countries. Recruiting first, the newest first:
Children's Cancer Group, China · Sites in China
Martin Schrappe · Sites in Australia, Austria, Czechia and 5 more countries
Charite University, Berlin, Germany · Sites in Australia, Austria, Belgium and 12 more countries
M.D. Anderson Cancer Center · Sites in United States
Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Sites in Armenia, Belarus, Kyrgyzstan and 2 more countries
By country, each count listing its studies:
Bortezomib: first FDA approval 2003 (VELCADE), first EMA approval 2004. What it is approved for, and how studies give it, is on its page →
Of the 370 Precursor Cell Lymphoblastic Leukemia-Lymphoma studies recruiting now, 96 (26%) set no upper age limit and 257 (69%) stop at 75 or younger; 247 take children under 18; 29 take healthy volunteers.
This study: 16 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 21 · Phase 3 3 · Phase 4 1
First in 1999; this study’s year is marked. 1 started in 2024.
This study's planned enrollment of 50 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Median enrollment 36 across the 33 interventional studies. Of the 24 that completed or were terminated, 12 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 36 has an industry lead sponsor. The 10 most frequent:
Instituto do Cancer do Estado de São Paulo is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
Instituto do Cancer do Estado de São Paulo has 2 studies filed under Precursor Cell Lymphoblastic Leukemia-Lymphoma — fewer than ten, so there is no comparison to draw.
2 of the studies testing bortezomib in Precursor Cell Lymphoblastic Leukemia-Lymphoma that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05681260Phase 3Children's Cancer Group, ChinaCapizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) | 2026-12-31 |
| NCT03136146M.D. Anderson Cancer CenterCombination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia | 2027-08-01 |
Among the 36 studies testing bortezomib in Precursor Cell Lymphoblastic Leukemia-Lymphoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a interventional phase II study aiming to examine the complete response rate of a bortezomib-based salvage regimen in adults with refractory or relapsed acute lymphoblastic leukemia (ALL), seeking to compare outcomes with the available literature and with our historical data on relapsed/refractory ALL.
Acute lymphoblastic leukemia (ALL) is a rare neoplasm in adults, with long-term survival rates approaching 50% with current regimens. Although high rates of complete response are achieved with the first-line therapy, many patients are primary refractory or may further relapse. Arguably, these patients have a more resistant disease with higher risk genetic alterations and a much less likely to be cured, which almost always only can be obtained by a following allogeneic hematopoietic stem-cell transplantation (HSCT). Therefore, strategies to salvage patients with detectable disease after induction blocks or with relapsed disease are crucial to prolong survival and potentially cure those patients, working as a bridge therapy to HSCT. Historically, patients with relapsed/refractory ALL have received multidrug regimens based on high-dose cytarabine, such as fludarabine, cytarabine and idarubicin (FLAG-IDA). Those regimens provide a 30-40% complete response rate with non-negligible toxicity. Recently, new targeted agents such as blinatumomab, inotuzumab, and cellular therapies have arisen for B-lineage disease, even though these agents are not available in the public health setting. Previous studies have tested salvage regimens for ALL encompassing proteasome inhibitors plus highly synergistic drugs (dexamethasone, vincristine, asparaginase, doxorubicin), with exciting outcomes in limited case series. For adults, these regimens are less studied. However, preliminary data suggest that they are less toxic and more potent since patients can receive different drug combinations that they had not been exposed to before. The primary objective of this study is to examine the complete response rate of this regimen in our population, aiming to compare with the available literature and with our historical data on relapsed/refractory ALL. Secondary objectives are:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with refractory or relapsed acute lymphoblastic leukemia will receive one-two courses of salvage regimen composed by: * Bortezomib 1.3 mg/m2 I.V. D1,D4,D8,D11; * Vincristine 1.5 mg/m2 I.V. (maximum at 2 mg) - D1, D8,D15,D22; * Doxorubicin 60 mg/m2 I.V. - D1; * Peg-asparaginase 2000 IU/m2 I.V. - D4 and D18; * Dexamethasone 20 mg/m2 P.O. or I.V. (divided BID) - D1-D5 and D15-D19 * Intrathecal chemotherapy: methotrexate 12 mg + dexamethasone 2 mg.
Drug: Bortezomib
Patients should receive one or two courses of this regimen, aiming to achieve complete remission as a bridge to proceed with allogeneic HSCT.
Also known as: Vincristine, Doxorubicin, Peg-asparaginase, Dexamethasone, Methotrexate
Complete response
Disappearance of lymphoid blasts in peripheral blood, with fewer than 5% of lymphoid blasts quantified in the bone marrow aspirate through immunophenotyping.
Time frame: 30 days
Event-free survival
Time interval between study enrollment and the occurrence of an event (non-response, relapse, or death) or last follow-up (censorship).
Time frame: 1 year
Overall survival
Time interval between study enrollment and the occurrence of death or last follow-up (censorship).
Time frame: 1 year
Rate of MRD-negativity
Absence of pathological lymphoid blasts in a bone marrow sample detected through immunophenotyping with a minimum sensitivity of 10-4.
Time frame: 60 days
Rate of allogeneic hematopoietic stem-cell transplantation
Proportion of patients who successfully underwent allogeneic hematopoietic stem-cell transplantation after the study therapy
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Aug 2028, 52 months after the start.
Of 208 non-industry phase 2 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 120. This study's planned 52 months is below that.
Counting every sponsor, half of 226 studies reached it within 74 months; a quarter within 42 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Bortezomib
Precursor Cell Lymphoblastic Leukemia-Lymphoma →
Instituto do Cancer do Estado de São Paulo