New drug cocktail aims to improve remission in older leukemia patients
NCT ID NCT02494882
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This phase I trial tests the safety of adding ruxolitinib to a standard combination of dasatinib and dexamethasone for adults aged 40 and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study starts with a low dose of ruxolitinib and gradually increases it to find the safest dose. All three drugs have been used before in humans, but this is the first time they are combined for this condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ruxolitinib, Dasatinib, Dexamethasone
- What this could lead to
- If this combination proves safe, it could lead to a more effective remission induction therapy for older adults with Ph+ ALL.
- What could go wrong
- This is a small, early-phase safety study, so the combination may not work better than standard treatments and could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Jun 2015
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient able to give informed consent. * Patients \>/= 18 years with the following disease will be eligible * Newly diagnosed Ph+ ALL, previously untreated, except for the below allowances * Previously received HpyerCVAD cycle 1A+/- cycle 1B * Previously received Induction Phase 1 +/- Induction Phase II of BFM-modeled (Pediatric of Pediatric-Inspired) ALL regimen * Previously received other representative (modified from HyperCVAD, BFM, or AML-like) ALL induction course, including ABL TKI plus corticosteroid. * If the patient has received any of the above prior therapy, they may be enrolled, regardless of remission status. * Relapsed PH+ ALL, with no prior exposure to dasatinib and without known ABL kinase mutations predited to be resistant to dasatibin (e.g. L248R, L248V, Q252H, E255K, V299L, T315A, T315I, F317C, F317L, F317S, F317V) * Relapsed or refractory Ph-like ALL without prior exposure to dasatibin and with mutations or rearrangements of genes conferring sensitivity to dasatibin (ABL, CSF1R, PDGFRB) or ruxolitinib (CRLF2, JAK3, EPOR, TSLP) * Newly diagnosed or relapsed CML in lymphoid blast crisis * Confirmation of Philadelphia chromosome positivity by cytogenetics (karyotype/FISH) and/or molecular tests (BCR-ABL1 transcripts) * Acceptable end-organ function, except for documented exclusions for organ function compromise due to ALL itself * ECOG performance status ≤ 2 * Men and women of childbearing potential must be willing to practice an effective method of birth control during treatment and for at least 4 months following treatment on study Exclusion Criteria: * Ph-negative ALL * Patients with dominant leukemic clone bearing documented bcr-abl mutations enabling bcr-abl TKI resistance at diagnosis * Mature B-cell (Burkitt's) ALL * Serum creatinine \> 1.5x ULN and calculated creatinine clearance, based on a 24-hour urine collection, \< 30 mL/min--unless related to ALL/tumor lysis syndrome and able to be corrected * Direct Bilirubin \> 2x ULN; AST/ALT \> 10x ULN, unless related to ALL liver infiltration. * Pregnant women or women who are breast-feeding * Patients with HIV, Hepatitis B, or Hepatitis C * Pre-treatment QTcF \> 480 msecs * A "washout" period of at least 14 days from last previous cytotoxic chemotherapy will be required prior to starting treatment on this protocol. No "washout" period will be required for previous bcr-abl TKI therapy given with the aforementioned previous chemotherapy cycles. Hydroxyurea and corticosteroids may be given as bridge therapy up until 24 hours prior to initiating protocol treatment. * Active malignancy requiring treatment other than ALL within two years prior to start of treatment, with the exception of basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, localized prostate cancer, or DCIS or LCIS of the breast * Active, uncontrolled infection, any other concurrent disease, or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator * Unable to tolerate anti-viral and anti- Pneumocystis jirovecii prophylaxis while on pre-phase and remission induction therapy * Unable to tolerate gastrointestinal prophylaxis therapy with sucralfate while on pre-phase and remission induction therapy. Or severe pre-existing GI disorder that requires PPI or H2 receptor antagonist therapy be uninterrupted
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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