Hyper-CVAD Regimen in Sequential Combination With Blinatumomab as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia



Status:Recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:14 - Any
Updated:11/8/2018
Start Date:November 1, 2016
End Date:November 2020
Contact:Elias Jabbour, MD
Phone:713-792-4764

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Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia (ALL)

Objectives:

Objectives

Primary Objectives: To evaluate the clinical efficacy of the sequential combination of
hyper-CVAD + blinatumomab in patients with newly diagnosed B-cell acute lymphoblastic
leukemia (ALL) in terms of relapse-free survival (RFS)

Secondary Objectives: To evaluate other efficacy endpoints such as overall survival, overall
response rate, MRD negativity rate as well as the safety of this combination.


Inclusion Criteria:

1. Patients at least 14 years of age with newly diagnosed, previously untreated B-lineage
ALL or lymphoblastic lymphoma, or having achieved CR with one course of induction
chemotherapy. Patients who require steroids, ara-c or hydrea to manage disease
symptoms prior to finalization of diagnosis and treatment plan are allowed and
eligible.

2. Failure to one induction course of chemotherapy (these patients will be analyzed
separately). Patients who require steroids, ara-c or hydrea to manage disease symptoms
prior to finalization of diagnosis and treatment plan are allowed and eligible.

3. Performance status of 0-3

4. Adequate organ function with creatinine less than or equal to 2.0 mg/dL (unless
considered tumor related), bilirubin less than or equal to 2.0 mg/dL (unless
considered tumor related).

5. Adequate cardiac function as assessed by history and physical examination.

6. No active co-existing malignancy with life expectancy less than 12 months, sources for
the determination of clinical significance by the treating physician will be included
in the subject's medical record.

Exclusion Criteria:

1. Pregnant or nursing women.

2. Known to be HIV-positive

3. Ph-positive ALL

4. Active and uncontrolled disease/infection as judged by the treating physician, sources
for the determination of clinical significance by the treating physician will be
included in the subject's medical record

5. Unable or unwilling to sign the consent form

6. Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable
chronic liver disease per treating physician assessment), sources for the
determination of clinical significance by the treating physician will be included in
the subject's medical record

7. History or presence of clinically relevant CNS pathology such as epilepsy, childhood
or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia,
Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
[Patients with CNS involvement of leukemia are NOT excluded.]

8. Current autoimmune disease or history of autoimmune disease with potential CNS
involvement. Auto-immune disease with possible CNS consequences/manifestations such as
such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar
disease, or psychosis.

9. Subjects who weigh less than 45 kg.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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