OnCo
trialsTrialPositive

D-ALBA (GIMEMA LAL2116)

The trial that showed Ph-positive ALL can be treated with a pill plus an immunotherapy and no chemotherapy, with 95% of patients alive at 18 months.

63 patients (median age 54): molecular response 60% after two blinatumomab cycles rising with further cycles; 18-month OS 95%, DFS 88%; only half went to transplant. NEJM 2020. Four-year update: OS ~80%, DFS ~75%, with IKZF1-plus and T315I relapses. Successor trials (GIMEMA ALL2820 with ponatinib) and MD Anderson ponatinib-blinatumomab series extend the chemotherapy-free approach.

Setting
Newly diagnosed Ph-positive ALL, adults of all ages: dasatinib induction followed by blinatumomab, no systemic chemotherapy
Phase
Phase 2
Sponsor
GIMEMA
Registry
Headline result
18-month OS 95%, DFS 88%.
Reported
2020
Enrolled
63
Replication
MD Anderson ponatinib + blinatumomab phase 2 (Jabbour et al.) reproduced near-universal molecular remission without chemotherapy; randomised confirmation (GIMEMA ALL2820, EWALL) pending.

Outcomes

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In plain words
What these results mean for people, not percentages
63 people took part
Disease-free survival at 18 monthsprimarysurrogate endpoint
  • 88 out of 100 people alive without the cancer coming back at 18 months with Dasatinib → blinatumomab.
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survival at 18 monthssurvival endpoint
  • 95 out of 100 people alive at 18 months with Dasatinib → blinatumomab.
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
  • There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
  • These results apply to the people the trial enrolled: Newly diagnosed Ph-positive ALL, adults of all ages: dasatinib induction followed by blinatumomab, no systemic chemotherapy. People in a different situation may not see the same effect.
  • Only 63 people took part, so the numbers are less certain than in a large trial.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

63 participants enrolled.

Disease-free survival at 18 monthsprimary
Dasatinib → blinatumomab88 of 100
Overall survival at 18 months
Dasatinib → blinatumomab95 of 100
n = 63
Source
EndpointArmnValueHR (95% CI)pSource
Overall survival at 18 monthsDasatinib → blinatumomab6395%link
Disease-free survival at 18 monthsprimaryDasatinib → blinatumomab88%
Replication
MD Anderson ponatinib + blinatumomab phase 2 (Jabbour et al.) reproduced near-universal molecular remission without chemotherapy; randomised confirmation (GIMEMA ALL2820, EWALL) pending.

Connected

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