Key points
- ALL is the most common cancer in children, but it also occurs in adults, and in adults it is harder to treat [1]; newer treatment programmes have greatly improved the results [5, 6, 10].
- The first question is whether the cells carry the Philadelphia chromosome. In this type, which affects about 1 in every 5 adults with ALL, a targeted tablet such as imatinib or dasatinib is added to treatment [1, 11, 13].
- The MRD test, which finds the very few leukaemia cells left after treatment, is the most important guide to further treatment and shows who needs more drugs or a transplant [8, 9, 20].
- Adding blinatumomab to the consolidation phase lengthened patients' lives in adults whose MRD had become negative [10].
- If the disease comes back, newer immunotherapy drugs (blinatumomab and inotuzumab) and CAR-T cell therapy can bring about remission again and open the way to a transplant [15, 16, 18, 20].
What is ALL, and why is it different in adults?
Acute lymphoblastic leukaemia (ALL) is a cancer of the blood and bone marrow: instead of healthy cells, the blood-forming stem cells make large numbers of immature lymphocytes. The more of these cells there are, the less room is left for healthy white cells, red cells and platelets; this is why infection, anaemia and easy bleeding occur [2]. Tiredness, fever or night sweats, easy bruising, breathlessness, weight loss and bone pain are among its symptoms [2]; see the symptoms in What are the symptoms of blood cancer?
ALL is the most common cancer in children, and its treatment in children is one of the great successes of medicine: among more than 21,000 children and teenagers, 9 in every 10 were alive 5 years later [1, 3]. In adults the results are not as good [1]. One reason is that a high-risk genetic change called the Philadelphia chromosome is more common in adults [1]; another is that, with increasing age, the body tolerates intensive treatment less well [4, 5].
With today's treatment programmes, more than half of adults younger than 55 were alive and free of relapse 5 years later; at 55 and older, when intensive treatment is tolerated less well, the figure was about a quarter [4]. Adding newer drugs, described further down, has improved the results further [10].
The story of treatment: from intensive chemotherapy to immunotherapy
For years, treatment of ALL in adults was several cycles of intensive chemotherapy. With one widely used regimen, 9 in every 10 patients went into remission, but only about 4 in every 10 were alive 5 years later [7].
The next big step was treating adults with programmes inspired by children's treatment: drugs such as steroids, vincristine and asparaginase at higher doses [5]. In patients aged 15 to 60, this approach clearly improved the results, at least up to the age of 45 [5]. In teenagers and young adults aged 17 to 39, too, with the children's programme the time free of relapse became more than twice as long as in earlier groups [6].
Then targeted tablets arrived for the Philadelphia-positive type [11, 12]. In recent years immunotherapy drugs have arrived: blinatumomab, which links the patient's immune cells to the leukaemia cells [22]; inotuzumab, an antibody that delivers a powerful drug to the leukaemia cell [16]; and CAR-T cell therapy [18, 19]. These drugs first showed in relapsed disease that they work better than chemotherapy [15, 16], and now blinatumomab has reached first-line treatment too [10].
Philadelphia-positive or negative: why does it matter?
In some patients, a piece of chromosome 9 joins on to chromosome 22 and a new gene called BCR::ABL1 is formed; this is called the "Philadelphia chromosome" [2]. About 1 in every 5 adults with ALL has this change [1]. A similar change is seen in chronic myeloid leukaemia (CML), and the tablets that block the protein made by this gene are also used in Philadelphia-positive ALL [1, 2].
- If it is Philadelphia-positive: the targeted tablet imatinib or dasatinib is given from the start, together with chemotherapy and steroids [11, 13, 2]. In a large study, imatinib with lighter chemotherapy worked as well as intensive treatment and caused fewer deaths in the first phase of treatment [11]. The newer tablet ponatinib, with light chemotherapy, brought more patients into deep remission (MRD-negative) [12]. In smaller studies, combining a targeted tablet with blinatumomab, almost without chemotherapy, gave very good results; this approach is still being studied [13, 14].
- If it is Philadelphia-negative: the main treatment is multi-phase chemotherapy with programmes inspired by children's treatment [5, 6], and in the B-cell type (most patients) blinatumomab is added to the consolidation phase [10]. In the T-cell type, there are fewer treatment options if the disease comes back, so in high-risk patients a transplant is considered already in the first remission [20].
MRD: the remaining cells that decide the course of treatment
When, after the first phase of treatment, leukaemia cells can no longer be seen under the microscope, we say the disease is "in remission". But very sensitive tests on a bone marrow sample can find even 1 leukaemia cell among 10,000 cells; these remaining cells are called MRD [10, 20].
MRD is the strongest predictor of the disease coming back [9]. In a large analysis of more than 2,000 adults, those whose MRD became negative had a much lower risk of relapse and death [8]. About 3 to 5 in every 10 adults who reach remission after chemotherapy are still MRD-positive [9].
The MRD result decides the course of treatment: if MRD stays positive, blinatumomab makes it negative in most patients, and a bone marrow transplant is usually recommended after that [9, 20]. If MRD becomes negative, in the Philadelphia-negative B-cell type, adding blinatumomab to further treatment lengthened life [10]. The test must be done in an experienced laboratory with a standard method [20]; ask how your MRD is measured and at what time points.
The phases of treatment, step by step
- 1
Diagnosis and first tests
Blood tests and a bone marrow sample (usually from the hip bone) identify the type of leukaemia [2]. Genetic tests, including a check for the Philadelphia chromosome, are done, and sometimes a lumbar puncture (a sample of spinal fluid) shows whether the disease has reached the brain and spinal cord [2].
- 2
Induction treatment: reaching remission
The aim of the first phase of treatment is to clear the leukaemia cells from the blood and bone marrow: with several chemotherapy drugs plus steroids and, in the Philadelphia-positive type, plus a targeted tablet [2, 11]. In this phase white cell counts fall very low and the risk of infection and bleeding is high [29, 30]. After it, the bone marrow and MRD are checked again [10, 20].
- 3
Preventing the disease from reaching the brain and spinal cord
Leukaemia cells can hide in the brain and spinal cord, where most drugs do not reach; this is why, at different phases of treatment, chemotherapy is injected directly into the spinal fluid by lumbar puncture [2].
- 4
Consolidation and intensification: several more months of treatment
After remission, several more cycles of chemotherapy destroy the remaining cells [2]. In the Philadelphia-negative B-cell type, cycles of blinatumomab are also added: each cycle is 4 weeks of continuous infusion through a small portable pump, followed by 2 weeks' rest [10, 22]. The first few days of the early cycles are spent in hospital [22].
- 5
Maintenance treatment: tablets at home
- 6
Bone marrow transplant, for some patients
If the disease is high risk, if MRD does not become negative, or if the disease comes back, a stem cell transplant from a donor is recommended [20]. In older people, intensive treatment is tolerated less well and the decision is made with extra care [4, 20]. See: Blood stem cell transplant
If the disease comes back or does not respond to treatment
Blinatumomab
This antibody attaches with one end to the CD19 protein on the leukaemia cell and with the other end to immune T cells, and sets them against the leukaemia cell [22]. In a large study of adults with relapsed or refractory disease, it lengthened life more than chemotherapy and more patients reached complete remission [15]. Its important side effects are fever and low blood pressure (cytokine release syndrome) and nervous system problems such as tremor, confusion or seizures; do not drive during the infusion [22].
Inotuzumab
An antibody that delivers a powerful drug to leukaemia cells that carry the CD22 protein [16]. In a large study, it brought more than twice as many patients into complete remission as chemotherapy [16], and more patients were able to have a transplant [17]. Its important side effect is liver damage, especially blockage of the small veins of the liver, which happens mostly after a transplant [23].
Stem cell transplant
After reaching remission again, a transplant from a donor (a matched brother or sister, an unrelated donor or a half-matched donor) is recommended for most suitable patients [20]. See: The stages of a stem cell transplant
CAR-T cell therapy
The patient's own immune T cells are collected, changed in the laboratory so that they recognise the CD19 protein on the leukaemia cell, and given back to the patient once [18]. In adults with relapsed or refractory disease, 7 or more in every 10 patients went into remission [18, 19], but in some of them the disease came back [20]. After the infusion, stay near the treatment centre for at least 2 weeks and do not drive [27, 28]. See: What is CAR-T cell therapy?
Preventing infection during treatment
In most phases of ALL treatment, white cell counts fall and the body is weak against germs [29]. A few simple steps lower the risk of infection [29]:
- Wash your hands often with soap and water, and ask the people around you to do the same.
- Stay away from people who are ill and from crowded places.
- Cook meat thoroughly and wash fruit and vegetables well.
- Keep your mouth, skin and the catheter or port site clean (Caring for a port or catheter).
During high-risk periods your doctor may give medicines to prevent bacterial, fungal and viral infections; in people who take steroids for a long time, prevention of a type of pneumonia called pneumocystis is also needed [21]. Take these medicines exactly as scheduled. Have vaccines only on the advice of your treatment team, because the vaccine schedule is different for these patients [31]. See: Low blood counts and preventing infection
- "What type of ALL do I have, and does it carry the Philadelphia chromosome?" [1, 2]
- "When and how will my MRD be measured, and how will the result change my treatment?" [20, 10]
- "Is blinatumomab part of my treatment plan?" [10, 22]
- "Might I need a transplant, and should we start looking for a donor now?" [20]
- "What can I do to preserve my fertility before treatment starts?" [32]
When should I call my doctor?
In every phase of treatment: report a temperature of 38 °C or higher, chills or any sign of infection straight away; infection at this time can be dangerous [29]. Also report straight away bleeding that does not stop after a few minutes, blood in the urine or stools, a severe headache or confusion [30]. With blinatumomab: report fever, shaking hands, confusion, difficulty speaking or seizures straight away; do not change the pump settings yourself, and if the pump alarms, call straight away [22]. With inotuzumab: report yellowing of the skin or eyes, swelling or pain in the abdomen and rapid weight gain straight away [23]. With ponatinib: report chest pain or pressure, breathlessness, numbness or weakness on one side of the body, difficulty speaking or leg swelling straight away [24]. After CAR-T: report fever, chills, dizziness, breathlessness, a racing heart or confusion straight away [27]. If you have severe breathlessness, seizures, severe confusion or heavy bleeding, call your local emergency number.
Frequently asked questions
Can ALL in adults be cured?
Yes, in some patients. With today's programmes, more than half of adults under 55 were alive and free of relapse 5 years later [4], and adding blinatumomab in MRD-negative patients lengthened life further [10]. The chance of cure depends on age, the genetic type of the disease and the MRD result [1, 20]. See: Can blood cancer be cured?
How long does ALL treatment take?
What is blinatumomab, and how is it given?
It is an antibody that links immune T cells to leukaemia cells carrying the CD19 protein so that they destroy them [22]. It is infused into a vein continuously for 4 weeks through a small portable pump, followed by 2 weeks' rest [22]. A steroid is given before each cycle, and the first few days of the early cycles are spent in hospital [22].
Does every patient need a bone marrow transplant?
No. A transplant is mainly for people whose disease is high risk, whose MRD does not become negative, or whose disease has come back [20]. In the Philadelphia-positive type, too, with stronger tablets and immunotherapy drugs, the need for a transplant in patients who reach deep remission is being reconsidered [20, 14].
Who is CAR-T for?
For adults whose disease has come back or has not responded to treatment [27, 28]. In the studies most patients went into remission [18, 19], but in some of them the disease comes back [20]. Its important side effects are fever, low blood pressure and nervous system problems, which are managed in specialist centres [27].
Can I have children after treatment?
Many patients can; in one report, most women under 40 who survived acute leukaemia (about 5 in every 6) had their periods again [1]. But treatment can reduce fertility, so raise the ways of preserving fertility (such as freezing sperm or eggs) with your doctor before treatment starts [32]. See: Fertility and sex during cancer treatment
For physicians
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Background and paediatric-inspired regimens: COG (21,626 patients aged 0 to 22 years): 5-year survival 90.4% in 2000 to 2005 [3]. Hyper-CVAD (204 adults, median age 39.5 years, Ph-positive 16%): CR 91%, induction death 6% and 5-year survival 39% [7]. GRAALL-2003 (225 Ph-negative patients aged 15 to 60, median 31 years): CR 93.5%, 42-month EFS and OS 55% and 60%; best age cut-off 45 years, with chemotherapy-related death 23% versus 5% in older patients [5]. GRAALL-2005 (787 patients, median 36.1 years): CR 91.9%, 5-year EFS and OS 52.2% and 58.5%; hyper-C gave no overall benefit; 5-year EFS 55.7% below 55 years versus 25.8% at 55 and older (HR 2.16) [4]. CALGB 10403 (295 evaluable patients aged 17 to 39, median 24 years; doses and schedule identical to COG AALL0232): treatment-related mortality 3%, median EFS 78.1 months versus 30 months in historical controls, 3-year EFS and OS 59% and 73%; obesity and a Philadelphia-like expression signature associated with worse outcomes [6]. Dose: paediatric regimen in adolescents and young adults (CALGB 10403).
MRD: Meta-analysis (16 adult studies, 2076 patients): event-free survival HR for MRD negativity 0.28 and overall survival HR 0.28 [8]. BLAST (116 patients in CR with MRD ≥10⁻³): blinatumomab 15 µg/m² per day; complete MRD response after cycle 1 78%; in 110 Ph-negative patients, 18-month RFS 54% and median OS 36.5 months; in complete MRD responders, RFS 23.6 versus 5.7 months and OS 38.9 versus 12.5 months; grade 3 and 4 neurological events in 10% and 3% [9]. EBMT 2025: MRD is the most important prognostic factor in Ph-negative B-ALL; MRD above 0.01% after 3 blocks of standard therapy is an indication for allogeneic transplant (usually up to age 60); high-risk cytogenetics (low hypodiploidy, KMT2A rearrangement, t(8;14), complex karyotype with 5 or more abnormalities) even when MRD-negative, and Philadelphia-like ALL; change therapy before transplant in persistent or recurrent MRD [20]. Blinatumomab label for MRD ≥0.1% (CR1 or CR2): 28 µg/day (45 kg or more) on days 1 to 28 every 42 days, 1 induction cycle and up to 3 consolidation cycles, with prednisone 100 mg IV premedication [22].
E1910: 488 patients aged 30 to 70 (median 51 years) with BCR::ABL1-negative B-ALL; CR or CRi in 81% (395 of 488); 224 MRD-negative patients (below 0.01% by flow cytometry) were randomly assigned to 4 cycles of consolidation chemotherapy with or without 4 cycles of blinatumomab (28 µg per day for 4 weeks, with a 2-week interval); at a median follow-up of 43 months, 3-year OS 85% versus 68% (HR 0.41; 95% CI 0.23 to 0.73; P=0.002) and 3-year RFS 80% versus 64% (HR 0.53); treatment-related grade 3 or higher neurological or psychiatric adverse events 23% versus 5%; maintenance for 2.5 years from the start of intensification [10]. Label in consolidation: 28 µg/day (below 45 kg: 15 µg/m²/day, maximum 28) by continuous infusion for 28 days with 14 days off; dexamethasone 20 mg IV within 1 hour before the first dose of each cycle; hospitalisation for the first 3 days of cycle 1 and the first 2 days of cycle 2; intrathecal prophylaxis before and during treatment; CRS in 16% of recipients in consolidation and neurological toxicity across the trials about 65% (grade 3 or higher about 13%); avoid driving during the infusion [22]. Dose: blinatumomab in consolidation (E1910).
Philadelphia-positive ALL: GRAAPH-2005 (268 patients, median 47 years): high-dose imatinib with reduced-intensity chemotherapy versus imatinib/hyper-CVAD, CR 98% versus 91% (P=0.006) with fewer induction deaths, major molecular response 66% versus 64%; 5-year EFS and OS 37.1% and 45.6% with no difference between the arms; allogeneic transplant associated with better RFS (HR 0.69) and OS (HR 0.64) [11]. PhALLCON (245 patients, median 54 years, 2:1 allocation): ponatinib 30 mg/day versus imatinib 600 mg/day with reduced-intensity chemotherapy; MRD-negative CR at the end of cycle 3 34.4% versus 16.7% (P=0.002); median EFS not reached with ponatinib and 29 months with imatinib (EFS had not yet reached the prespecified number of events); arterial occlusive events 2.5% versus 1.2% [12]. Ponatinib label: 30 mg once daily with chemotherapy, reduced to 15 mg after MRD-negative CR (BCR::ABL1/ABL1 ≤0.01%) at the end of induction, for up to 20 cycles (accelerated approval); boxed warning for arterial occlusive events, venous thromboembolism, heart failure and hepatotoxicity [24]. D-ALBA (63 patients, median 54 years, range 24 to 82): dasatinib with corticosteroids, then 2 cycles of blinatumomab (more cycles in some patients); CR 98%, molecular response 29% at day 85 and 60% after 2 cycles of blinatumomab; 18-month OS and DFS 95% and 88%; worse outcome with IKZF1 plus; 24 patients had an allogeneic transplant [13]. Ponatinib + blinatumomab (single-centre phase 2): complete molecular response in 33 of 38 evaluable newly diagnosed patients (87%) [14]. Label doses in adult Ph+ ALL: imatinib 600 mg/day (label indication: relapsed or refractory) [25]; dasatinib 140 mg once daily (label indication: resistance or intolerance to prior therapy) [26]. EBMT: with imatinib and chemotherapy, allogeneic transplant in CR1 improves survival and is still indicated; with third-generation TKIs plus novel antibodies and deep MRD negativity, the indication may become more restricted [20]. Doses: imatinib + reduced-intensity chemotherapy · ponatinib (PhALLCON) · dasatinib and blinatumomab (D-ALBA).
Relapsed or refractory B-ALL: TOWER (405 patients, 2:1 allocation): blinatumomab versus chemotherapy, median OS 7.7 versus 4.0 months (HR 0.71), CR with full haematological recovery 34% versus 16% and CR/CRh/CRi 44% versus 25%, 6-month EFS 31% versus 12%; allogeneic transplant 24% in both groups; grade 3 or higher adverse events 87% versus 92% [15]. INO-VATE (326 patients; response analysis in the first 218): CR/CRi 80.7% versus 29.4%, MRD negativity among responders 78.4% versus 28.1%, PFS 5.0 versus 1.8 months (HR 0.45), OS 7.7 versus 6.7 months (HR 0.77; P=0.04) and VOD 11% versus 1% [16]; in the final report, CR/CRi 73.8% versus 30.9%, 2-year OS 22.8% versus 10.0% (HR 0.75), proceeding directly to transplant 39.6% versus 10.5% and VOD/SOS 14.0% versus 2.1% [17]. Inotuzumab label: cycle 1: 0.8 mg/m² on day 1 and 0.5 mg/m² on days 8 and 15 (21 days, up to 28 days); later cycles in CR/CRi: 0.5 mg/m² on days 1, 8 and 15 every 28 days; premedication with a corticosteroid, antipyretic and antihistamine; 2 cycles in transplant candidates (a third cycle if CR/CRi with MRD negativity has not been reached after 2 cycles); VOD risk is higher with conditioning containing two alkylating agents and with bilirubin ≥ the upper limit of normal before transplant [23]. ZUMA-3 (71 patients enrolled, 55 treated, median 40 years): brexucabtagene autoleucel 1 × 10⁶ CAR-positive cells/kg, CR/CRi 71% (CR 56%), median duration of remission 12.8 months and median OS 18.2 months, MRD negativity in 97% of responders, grade 3 or higher CRS 24% and grade 3 or higher neurological events 25%; 18% then had an allogeneic transplant [18]. FELIX (obecabtagene autoleucel; 153 patients enrolled, 127 infused): in cohort 2A overall remission 77% (CR 55%), median EFS 11.9 months and median OS 15.6 months, grade 3 or higher CRS 2.4% and grade 3 or higher ICANS 7.1% [19]; label: a total of 410 × 10⁶ CAR-positive cells given in two infusions on day 1 and day 10 according to the bone marrow blast percentage [28]. Brexucabtagene label: maximum 1 × 10⁸ cells; stay near the treatment centre and avoid driving for at least 2 weeks [27]. EBMT: relapse after CAR-T in 30 to 50% (CD19-negative relapse in up to 40%); molecular MRD positivity after CAR-T or loss of B-cell aplasia without a previous transplant makes a patient a candidate for consolidative allogeneic transplant; lymphodepletion with fludarabine and cyclophosphamide is better than cyclophosphamide alone; in T-ALL, salvage options are limited and transplant in CR1 should be considered in high-risk patients [20]. Doses: inotuzumab (INO-VATE) · brexucabtagene autoleucel (ZUMA-3); CAR-T and blinatumomab toxicity: immunotherapy toxicity lesson; transplant: transplant indications and donor selection.
Supportive care: ASCO/IDSA: antibacterial and antifungal prophylaxis for expected profound and prolonged neutropenia (below 100 neutrophils/µL for more than 7 days); aciclovir for HSV-seropositive patients during leukaemia induction; pneumocystis prophylaxis for regimens with a risk above 3.5% (for example, 20 mg or more of prednisone equivalent daily for 1 month or longer) [21]. See: Infection prevention and vaccination · Fever and neutropenia · Tumour lysis syndrome.
Scientific evidence
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Scientific evidence
10 itemsA pediatric regimen for older adolescents and young adults with acute lymphoblastic leukemia: results of CALGB 10403
Intensified Therapy of Acute Lymphoblastic Leukemia in Adults: Report of the Randomized GRAALL-2005 Clinical Trial
Diagnosis, prognostic factors, and assessment of ALL in adults: 2024 ELN recommendations from a European expert panel
Improved Survival for Children and Adolescents With Acute Lymphoblastic Leukemia Between 1990 and 2005: A Report From the Children's Oncology Group
Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults
Ponatinib vs Imatinib in Frontline Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia
Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia
Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia
KTE-X19 for relapsed or refractory adult B-cell acute lymphoblastic leukaemia: phase 2 results of the single-arm, open-label, multicentre ZUMA-3 study
Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia
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References
32 referencesShow all references, 11 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
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- 31Vaccination of Adults With Cancer: ASCO Guideline
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