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A Therapeutic Trial of Decitabine (Dacogen) and Vorinostat (SAHA) in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) MT2008-29R


Phase 2
2 Years
60 Years
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

A Therapeutic Trial of Decitabine (Dacogen) and Vorinostat (SAHA) in Combination With Chemotherapy (Vincristine, Prednisone, Doxorubicin and PEG-Asparaginase) for Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) MT2008-29R


OBJECTIVES:

Primary

- Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19
and at the end of study treatment for correlative laboratory studies. Samples are
analyzed for hypermethylation at diagnosis and demethylation post-exposure with
decitabine and vorinostat using LINE methylation.

OUTLINE:

Patients receive decitabine IV over 1 hour and oral vorinostat twice daily on days 1-4;
vincristine sulfate IV on days 5, 12, 19, and 26; oral prednisone twice daily on days 5-33;
doxorubicin hydrochloride IV over 15 minutes and cytarabine intrathecally (IT) on day 5;
pegaspargase IV or intramuscularly on days 6, 12, 19, and 26; and methotrexate* IT on days
12 and 33. Patients with Philadelphia chromosome-positive disease may also receive oral
imatinib mesylate once daily on days 5-33.

NOTE: *Patients with central nervous system (CNS)-positive disease also receive methotrexate
IT on days 19 and 26.

Patients undergo blood and bone marrow sample collection at baseline, on day 5, Day 19 and
at the end of study treatment for correlative laboratory studies.

After completion of study treatment, patients are followed for 60 days.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response to Treatment

Outcome Description:

as measured by remission rate at day 33 (< 5% blasts) or day 42 per RECIST criteria

Outcome Time Frame:

Day 33 or Day 42

Safety Issue:

No

Principal Investigator

Michael J. Burke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2008LS112

NCT ID:

NCT00882206

Start Date:

April 2009

Completion Date:

January 2013

Related Keywords:

  • Leukemia
  • Lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent childhood lymphoblastic lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Minnesota Amplatz Children's HospitalMinneapolis, Minnesota  55455