Clinical trial · Interventional
Pre-reinductive Decitabine and Vorinostat in Relapsed Lymphoblastic Lymphoma or Acute Lymphoblastic Leukemia
A Therapeutic Trial of Decitabine and Vorinostat in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine and vorinostat may alter the cancer cells by reversing the cancer pathways needed for cell growth. Giving more than one drug (combination chemotherapy) together with decitabine and vorinostat may kill more cancer cells than with chemotherapy alone. PURPOSE: This phase II trial is studying how well giving decitabine and vorinostat together with combination chemotherapy works in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma that has relapsed or not responded to treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| decitabine | Drug | Decitabine | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| imatinib mesylate | Drug | Imatinib Mesylate | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| pegaspargase | Drug | Pegaspargase | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Decitabine / Vorinostat
- description
- This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
- interventionNames
- Drug: cytarabine
- Drug: decitabine
- Drug: doxorubicin hydrochloride
- Drug: imatinib mesylate
- Drug: methotrexate
- Drug: pegaspargase
- Drug: prednisone
- Drug: vincristine sulfate
- Drug: vorinostat
Primary outcomes (1)
- measure
- Response to Treatment
- timeFrame
- Day 33
- description
- Response includes both complete remission (defined as \<5% leukemic blasts in the bone marrow) and partial remission (defined as a greater than 35% reduction in the bone marrow leukemia blast percentage at day 33)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of lymphoblastic lymphoma or acute lymphoblastic leukemia with ≥ 5% blasts in the bone marrow (M2/M3) (with or without extramedullary disease) that meets 1 of the following criteria: * Refractory disease/induction failure (failure to achieve initial remission after 2 lines of induction therapy) * Relapsed disease (in first relapse or higher) * Central nervous system (CNS)-positive disease allowed * Karnofsky performance status (PS) 50-100% (for patients ≥ 16 years of age) OR Lansky PS 50-100% (for patients \< 16 years of age) * Life expectancy ≥ 8 weeks * Creatinine clearance ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows: * 0.4 mg/dL (for patients 1 to 5 months of age) * 0.5 mg/dL (for patients 6 to 11 months of age) * 0.6 mg/dL (for patients 1 year of age) * 0.8 mg/dL (for patients 2 to 5 years of age) * 1.0 mg/dL (for patients 6 to 9 years of age) * 1.2 mg/dL (for patients 10 to 12 years of age) * 1.5 mg/dL (males) or 1.4 mg/dL (females) (for patients 13 to 15 years of age) * 1.7 mg/dL (males) or 1.4 mg/dL (females) (for patients ≥ 16 years of age) * ALT \< 5 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times ULN for age * LVEF ≥ 40% by ECHO/MUGA scan * Shortening fraction \> 29% by ECHO/MUGA scan * Able to swallow capsules * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after completion of study treatment * No untreated positive blood cultures or progressive infections as assessed by radiographic studies * No known allergy to any of the agents or their ingredients used in this study * Patients with clinically significant prior allergies to pegaspargase may be treated with asparaginase-Erwinia, if available * Patients who cannot receive asparaginase on this study (e.g., due to prior pancreatitis, stroke, or other toxicity) are eligible provided they meet all other inclusion/exclusion criteria * Recovered from prior therapy (defined as CTCAE v3.0 toxicity ≤ grade 1) * More than 3 weeks since prior chemotherapy for cancer other than hydroxyurea for patients with WBC \> 10,000/mm³ * At least 7 days since prior hematopoietic growth factors (14 days for pegfilgrastim) * At least 1 month since prior biologic therapy, such as monoclonal antibodies * At least 3 months since prior hematopoietic stem cell transplantation Exclusion Criteria: * Evidence of graft-versus-host disease * Concurrent valproic acid * Concurrent coumadin/warfarin other than a short course administered in a prophylactic setting
References
Publications (1)
- DERIVEDBurke MJ, Lamba JK, Pounds S, Cao X, Ghodke-Puranik Y, Lindgren BR, Weigel BJ, Verneris MR, Miller JS. A therapeutic trial of decitabine and vorinostat in combination with chemotherapy for relapsed/refractory acute lymphoblastic leukemia. Am J Hematol. 2014 Sep;89(9):889-95. doi: 10.1002/ajh.23778. Epub 2014 Jun 27. PMID 24891274