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Treatment of Older Adults With Acute Lymphoblastic Leukemia


Phase 2
51 Years
75 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

Treatment of Older Adults With Acute Lymphoblastic Leukemia


- This research study has stages of treatment as follows: 1) Induction 2) Consolidation
1 3) Stem cell of Bone Marrow Transplant (if the participant is eligible). If the
participant does not have a transplant: 4) CNS Therapy 5) Consolidation 2 6)
Continuation Therapy.

- During all phases of study treatment, participants will have additional tests and
procedures to monitor their health and for research purposes. These tests will
include: physical exams, blood tests, bone marrow aspirate/biopsy and EKGs and/or
ECHOs.

- INDUCTION STAGE: This stage lasts for about one month. The study drugs and the way
they are administered are as follows: Prednisone orally on days 1-21 for participants
less than 60 and days 1-7 for participants 60 or greater; Vincristine intravenously on
days 1, 8, 15 and 22; Doxorubicin intravenously on days 1 and 2; PEG-Asparaginase
intravenously on days 7 and 21; Cytarabine intrathecally on day 1; Methotrexate
intrathecally on day 29; Imatinib orally on days 14-29 if participant has the
Philadelphia Chromosome.

- After induction, if there is evidence of ALL in the spinal fluid, participants may need
to receive more intrathecal therapy.

- CONSOLIDATION 1 Therapy: This stage will last about one month. Participants will
receive Consolidation 1 Therapy, regardless of whether or not their ALL is in full
remission after Induction. The study drugs and the way they are administered are as
follows: Prednisone orally days 1-5; Clofarabine intravenously days 1-5;
PEG-Asparaginase intravenously days 1 and 15; Imatinib continues orally for
participants with the Philadelphia Chromosome.

- After the participants blood counts return to normal, their bone marrow will be tested.
If the bone marrow shows remission, participants will proceed to the next stage of the
study. If the bone marrow does not show remission, the participants will no longer
continue on this study.

- STEM CELL or BONE MARROW TRANSPLANTATION: The next stage is stem cell or bone marrow
transplantation if the participant is eligible. If the participant receives a stem
cell transplant, they will receive additional chemotherapy (separate from the study
drugs) followed by an infusion of stem cells. If the participant receives a bone
marrow transplant, they will have a bone marrow aspirate and biopsy 3 months after the
transplant and 12 months from the start fo the induction to monitor the status of the
ALL. If the participant receives a bone marrow or stem cell transplant, they will
continue to be a part of the study, but will not proceed with CNS Therapy,
Consolidation 2 Therapy, and Continuation Therapy.

- CENTRAL NERVOUS SYSTEM (CNS) THERAPY: CNS therapy will begin between 2 and 6 weeks
following the end of Consolidation 1. This stage will last about one month. The study
drugs and the way they are administered are as follows: vincristine intravenously on
day 1; doxorubicin intravenously on day 1; 6 mercaptopurine orally on days 1-14;
prednisone orally on days 1-5; PEG-asparaginase intravenously on days 1 and 15;
methotrexate/cytarabine/prednisone intrathecally weekly for 3 weeks; imatinib orally
continues daily if the participant has the Philadelphia Chromosome.

- Radiation therapy will also be given during this stage of the participant is under 60
years old. The purpose of radiation therapy is to prevent ALL from coming back in the
brain. Radiation will be given in 8 treatments, given once a day, and will be
scheduled with other study treatment.

- CONSOLIDATION 2 THERAPY: This stage begins as soon as CNS Therapy ends and lasts about
8 months. Participants will receive repeated cycles of the study drug treatment about
every 4 weeks. The study drugs and the way they are administered are as follows:
vincristine intravenously on day 1; doxorubicin intravenously on day 1; 6
mercaptopurine orally on days 1-14; prednisone orally days 1-5; PEG-asparaginase orally
on days 1 and 15 (first cycle only); imatinib orally continues daily if the participant
has Philadelphia chromosome.

- CONTINUATION THERAPY: This stage begins at the end of Consolidation 2 Therapy. The
goal of this stage is to get rid of all of the ALL in the body. Participants will
receive repeated cycles of the study drug treatment every 4 weeks. It will last until
the participant has been in remission for 2 years. The study drugs and the way they
are administered are as follows: vincristine intravenously on day 1; mercaptopurine
orally on days 1-14; prednisone orally on days 1-5; methotrexate intravenously on day
15; imatinib orally continues daily if the participant has Philadelphia chromosome.


Inclusion Criteria:



- Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of
any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32),
t(8;22), or t(2;8).

- Patients with mature B-cell ALL will be removed from the protocol as soon as the
diagnosis is made and should be treated on a B-cell leukemia protocol.

- Patients with lymphoblastic lymphoma are also eligible

- No prior anti-leukemic therapy except <1 week of steroids, and/or emergent radiation
therapy to the mediastinum, or hydroxyurea or emergent leukopheresis. Longer steroid
use for diseases other than leukemia is permitted.

- Age 51-75 years

- Ejection fraction > 45%

- Creatinine < 2.0 mg/dl

- Total bilirubin < 3.0 mg/dl

- ECOG Performance Status of 0, 1, 2

- Non-pregnant and non lactating

Exclusion Criteria:

- Known HIV positive

- Comorbid medical condition, in the investigator's opinion, would make participation
in this trial and adherence to the protocol guidelines difficult

- Active psychiatric or mental illness making informed consent or careful clinical
follow-up unlikely

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the feasibility, toxicity and efficacy of this aggressive treatment regimen in adult patients 51-75.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Karen Ballen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

08-356

NCT ID:

NCT00973752

Start Date:

August 2009

Completion Date:

December 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • ALL
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617