Ibrutinib in Treating Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Conditions

• Adult B Acute Lymphoblastic Leukemia
• Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34;q11.2); BCR-ABL1
• Recurrent Adult Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ibrutinib — DRUG
  Given orally 560 mg daily (dispensed as 4 x 140-mg capsules)
• Laboratory Biomarker Analysis — OTHER
  Correlative studies

Study Details

This phase II trial studies how well ibrutinib works in treating patients with B-cell acute lymphoblastic leukemia that has come back after treatment or has not responded to other treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date

Apr 30, 2014

Status verified

Nov 2016

Primary completion

Nov 30, 2015

Completion

Nov 30, 2015

Study Design

Enrollment

3 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (ibrutinib)
  Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 3 months after treatment ]

Locations (8)

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